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Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00455533
Collaborator
(none)
384
Enrollment
50
Locations
2
Arms
26
Duration (Months)
7.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as discover new biomarkers that could identify patients who are more likely to respond to ixabepilone than standard paclitaxel based therapy.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
384 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women With Early Stage Breast Cancer
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Drug: Ixabepilone
Intravenous Solution, intravenous (IV), 40mg/m², Day 1 every 21 days, 12 Weeks
Other Names:
  • Epothilone
  • IXEMPRA®
  • BMS-247550

    • Drug: Cyclophosphamide
    Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks

    Drug: Doxorubicin
    Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 Weeks
    Active Comparator: B

    Drug: Paclitaxel
    Intravenous Solution, IV, 80mg/m², Weekly, 12 Weeks

    Drug: Cyclophosphamide
    Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks

    Drug: Doxorubicin
    Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 Weeks

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving Pathologic Complete Response (pCR) [at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)]

      The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.

    2. Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations [pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.]

      Beta III tubulin positivity determined by cross-validation method. Optimal cutoff: ≥46% tumor cells staining at 2 plus or 3 plus intensity (corresponding Beta III tubulin positivity=39.4%). Pre-specified cutoff of Beta III tubulin positivity: ≥50% 2plus or 3plus cells (corresponding prevalence=38.5%). Optimal cutoffs for TACC3 and CAPG positivity determined by cross-validation method: 6.889 and 6.844 [log2 normalized intensity units], respectively (corresponding to prevalence rates of 43.3% and 44.3%).

    3. Percentage of Participants Achieving Pathologic Complete Response (pCR) in 20- and 26-Gene Model Subgroups [pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.]

      For each of the 2 biomarker sets (20-gene or 26-gene), a multi-gene model was built using penalized logistic regression on all pharmacogenomic evaluable subjects for each treatment arm separately. Receiver Operating Characteristic (ROC) plots for separate arm using 5 fold cross validation were generated. ROC for separate arms using cross over were also added. Further analysis on the multiple gene models (as mentioned in the SAP) was planned only based on the initial findings from the 2 ROC plots. For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.

    Secondary Outcome Measures

    1. Percentage of Participants Achieving Clinical Objective Response [after the last dose of either ixabepilone or paclitaxel (at 12 weeks) but before surgery (4-6 weeks after the last dose of 12 weeks of therapy)]

      Clinical response was defined as the number of participants who achieved modified World Health Organization's tumor response criteria of clinical complete response (complete disappearance of all clinically palpable detectable malignant disease and/or disappearance of radiological evidence of tumor in the breast and ipsilateral axillary lymph nodes) or clinical partial response (clinical evidence of a reduction in total tumor size of >= 50% in the overall sum of the products of diameters of breast and axillary lesions), divided by the number of randomized participants in that arm.

    2. Percentage of Participants Requiring Breast Conservation Surgery [at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)]

      Number of randomized participants requiring breast conservation surgery following study treatment.

    3. Percentage of Participants Achieving Combined pCR and Minimal Residual Cancer Burden (RCB) 1 [at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)]

      Combined pCR and RCB-1 was defined as participants with no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of DCIS in the breast plus subjects with RCB-1 following the RCB calculation based on data entered by the investigator sites in each arm.

    4. Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR [pCR evaluated at time of surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.]

      Relevance of biomarker in differentiation between ixabepilone & paclitaxel evaluated by logistic regression with pCR as response. Statistical analyses include: 1) the likelihood ratio test between the full model (PCR~Biomarker:Treatment:estrogen receptor [ER]) & reduced model (PCR~Treatment:ER); 2) the likelihood ratio test between the full model (PCR~Biomarker:Treatment) & reduced model (PCR~Biomarker+Treatment); 3) the contrast of the interaction between treatment & biomarker expression within ER Negative subjects from the full model(PCR~Biomarker:Treatment:ER). A:B represents A,B & A*B.

    5. Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 [pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.]

      Relevance of biomarker in differentiation between ixabepilone & paclitaxel evaluated by logistic regression with pCR/RCB1 as response. Statistical analyses include: 1) likelihood ratio test between the full model (pCR/RCB1~Biomarker:Treatment: ER) & reduced model (pCR/RCB1~Treatment:ER); 2) likelihood ratio test between the full model (pCR/RCB1 Biomarker:Treatment) & reduced model (pCR/RCB1~Biomarker+Treatment); 3) contrast of the interaction between treatment & biomarker expression within ER Negative subjects from the full model (pCR/RCB1~Biomarker:Treatment:ER). A:B represents A,B & A*B.

    6. Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-Specified Thresholds [: pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.]

      Percentage of participants with pCR in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.

    7. Percentage of Participants With pCR/RCB1 and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds [pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.]

      Percentage of participants with pCR/RCB1 in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score .

    8. Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds, Estrogen-Receptor (ER) Negative Participants [pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.]

      Percentage of ER negative participants with pCR and MDR1 immunohistochemistry (IHC) positivity using 2 pre-specified thresholds, stratified by biomarker status. The first pre-specified threshold for MDR1-positivity (Mem)=Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.

    9. Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants) [pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy and mRNA samples obtained prior to treatment]

      Percentage of participants having the following optimal biomarker thresholds as computed from the cross-validation method (cutoff of biomarker positive [with 90% confidence interval by Bootstrap method]): Beta 3 Tubulin IHC (45.866 [5, 83.9]); TACC3 mRNA (6.714 [6.312, 7.192]); CAPG mRNA (6.739 [5.728, 7.298]). Optimal thresholds for a 20-gene model and a 26-gene model were also planned; however, these were not determined because preliminary analyses did not indicate that they would not differentiate pCR rates between treatment arm.

    10. Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants [prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy]

      AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. By Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grades

    11. Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class [prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy]

      MCT=musculoskeletal and connective tissue, GDASC=general disorders and administration site conditions, RTM=respiratory, thoracic and mediastinal disorders, NBMUCP=neoplasms benign, malignant and unspecified (including cysts and polyps). Drug related adverse events are those events with relationship to study therapy of certain, probable, possible or missing. Subjects may have more than one event within a class. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)

    12. On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase [prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase]

      AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)

    13. On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase [prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of study therapy during ixabepilone or paclitaxel treatment phase]

      Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)

    14. On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase [prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase]

      AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)

    15. Number of Participants by Dose for AC [12 weeks (4 3-week cycles)]

    16. Number of Participants by Dose for Ixabepilone/Paclitaxel [12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)]

    17. Reason for First Dose Reduction of AC [12 weeks (4 3-week cycles)]

    18. Reason for First Dose Reduction of Ixabepilone/Paclitaxel [12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)]

    19. Number of Participants With Course Delay and Reason for Delay for AC [12 weeks (4 3-week cycles)]

    20. Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel [12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    Inclusion criteria

    • Histologically confirmed primary invasive adenocarcinoma of the breast , T2-3, N0-3, M0, with tumor size of ≥ 2 cm

    • All patients with early stage breast adenocarcinoma may enroll irrespective of receptor status

    • No prior treatment for breast cancer excluding therapy for DCIS

    • Karnofsky performance status of 80 - 100

    • left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multiple gated acquisition (MUGA)

    • Adequate hematologic, hepatic and renal function

    Exclusion Criteria

    • women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy during and up to 8 weeks after the last dose of the investigational drug

    • Women who are pregnant or breastfeeding

    • Inflammatory or metastatic breast cancer

    • Unfit for breast and/or axillary surgery

    • Evidence of baseline sensory or motor neuropathy

    • Significant history of cardiovascular disease, serious intercurrent illness or infections including known human immu immunodeficiency virus (HIV) infection

    • History of prior anthracycline therapy Allergies to any study medication or Cremophor® EL

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Comprehensive Cancer Center Palm Springs California United States 92262
    2 Northwest Oncology & Hematology Associates Coral Spring Florida United States 33065
    3 Florida Cancer Research Institute Davie Florida United States 33328
    4 Medical Specialists Of Palm Beaches Lake Worth Florida United States 33467
    5 Moffitt Cancer Center Tampa Florida United States 33612
    6 University Medical Center, Inc Louisville Kentucky United States 40202
    7 University Of New Mexico Cancer Center Albuquerque New Mexico United States 87131
    8 Albert Einstein Cancer Center Bronx New York United States 10461
    9 Virginia Mason Medical Center Seattle Washington United States 98101
    10 Providence Cancer Center Spokane Washington United States 99204
    11 Local Institution Capital Federal Buenos Aires Argentina 1417
    12 Local Institution Capital Federal Buenos Aires Argentina 1425
    13 Local Institution Buenos Aires Argentina 1180AAX
    14 Local Institution Buenos Aires Argentina 1650
    15 Local Institution Salzburg Austria 5020
    16 Local Institution Vienna Austria 1090
    17 Local Institution Wien Austria 1090
    18 Local Institution Bordeaux France 33000
    19 Local Institution Saint Herblain France 44805
    20 Local Institution Duesseldorf Germany 40235
    21 Local Institution Erlangen Germany 91054
    22 Local Institution Jena Germany 07743
    23 Local Institution New Delhi Delhi India 110 095
    24 Local Institution Bangalore Karnataka India 560029
    25 Local Institution Trivandrum Kerala India 695011
    26 Local Institution Pune Maharashtra India 411001
    27 Local Institution Bhopal India 462001
    28 Local Institution Hyderabad India 500 004
    29 Local Institution Mumbai India 400012
    30 Local Institution Vellore India 632004
    31 Local Institution Bologna Italy 40138
    32 Local Institution Seoul Korea, Republic of 135-710
    33 Local Institution Seoul Korea, Republic of 135-720
    34 Local Institution Callao Peru 2
    35 Local Institution Lima Peru 34
    36 Local Institution Lima Peru LIMA 11
    37 Local Institution Cebu City Philippines 6000
    38 Local Institution Davao City Philippines 8000
    39 Local Institution Quezon City Philippines 1114
    40 Local Institution Kazan Russian Federation 420029
    41 Local Institution Moscow Russian Federation 129128
    42 Local Institution St Petersburg Russian Federation 197022
    43 Local Institution Singapore Singapore 308433
    44 Local Institution Barcelona Spain 08035
    45 Local Institution Jaen Spain 23007
    46 Local Institution Lleida Spain 25198
    47 Local Institution Taipei Taiwan 100
    48 Local Institution Taipei Taiwan 11217
    49 Local Institution Nottingham Nottinghamshire United Kingdom NG5 1PB
    50 Local Institution Coventry Warwickshire United Kingdom CV22DX

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00455533
    Other Study ID Numbers:
    • CA163-100
    • EUDRACT 2006-003047-24
    First Posted:
    Apr 3, 2007
    Last Update Posted:
    Feb 24, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by Bristol-Myers Squibb
    Early Breast Cancer
    Additional relevant MeSH terms:
    Breast Neoplasms
    Paclitaxel
    Epothilones
    Cyclophosphamide
    Doxorubicin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail A total of 384 participants were enrolled in this study; 71 did not receive any study medication.
    Arm/Group Title Doxorubicin / Cyclophosphamide (AC) Ixabepilone Paclitaxel
    Arm/Group Description 60 mg/m^2 doxorubicin and 600 mg/m^2 cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks). ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) Paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Period Title: Period One: Initial Chemotherapy
    STARTED 313 0 0
    COMPLETED 295 0 0
    NOT COMPLETED 18 0 0
    Period Title: Period One: Initial Chemotherapy
    STARTED 0 145 144
    COMPLETED 0 139 138
    NOT COMPLETED 0 6 6

    Baseline Characteristics

    Arm/Group Title Ixabepilone (Randomized Population) Paclitaxel (Randomized Population) Total
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks Total of all reporting groups
    Overall Participants 148 147 295
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    48.0
    46.0
    48.0
    Age, Customized (participants) [Number]
    <65 years
    134
    90.5%
    137
    93.2%
    271
    91.9%
    >=65 years
    14
    9.5%
    10
    6.8%
    24
    8.1%
    <50 years
    85
    57.4%
    82
    55.8%
    167
    56.6%
    >=50 years
    63
    42.6%
    65
    44.2%
    128
    43.4%
    Sex: Female, Male (Count of Participants)
    Female
    148
    100%
    147
    100%
    295
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (participants) [Number]
    White
    74
    50%
    76
    51.7%
    150
    50.8%
    Black/African American
    7
    4.7%
    4
    2.7%
    11
    3.7%
    Asian Indian
    22
    14.9%
    28
    19%
    50
    16.9%
    Chinese
    16
    10.8%
    12
    8.2%
    28
    9.5%
    Asian Other
    17
    11.5%
    14
    9.5%
    31
    10.5%
    Unknown or Not Reported
    12
    8.1%
    13
    8.8%
    25
    8.5%
    Karnofsky Performance Status-Baseline (participants) [Number]
    100 - Normal no complaints; no evidence of disease
    107
    72.3%
    103
    70.1%
    210
    71.2%
    90 - Normal activity; minor signs of disease
    28
    18.9%
    39
    26.5%
    67
    22.7%
    80 - Activity with effort; some signs of disease
    13
    8.8%
    5
    3.4%
    18
    6.1%
    70 - Unable to carry on normal activity
    0
    0%
    0
    0%
    0
    0%
    <=60 Needs increasing assistance up to Death (0)
    0
    0%
    0
    0%
    0
    0%
    Menopausal Status (Number) [Number]
    Pre-Menopausal
    71
    48%
    75
    51%
    146
    49.5%
    Peri-Menopausal
    6
    4.1%
    6
    4.1%
    12
    4.1%
    Post-Menopausal
    67
    45.3%
    64
    43.5%
    131
    44.4%
    Not Reported
    4
    2.7%
    2
    1.4%
    6
    2%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Achieving Pathologic Complete Response (pCR)
    Description The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.
    Time Frame at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 148 147
    Number (90% Confidence Interval) [Percentage of Participants]
    24.3
    16.4%
    25.2
    17.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8921
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8966
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.96
    Confidence Interval (2-Sided) 90%
    0.60 to 1.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter difference in pCR
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -7.9 to 6.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference in pCR rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.
    2. Secondary Outcome
    Title Percentage of Participants Achieving Clinical Objective Response
    Description Clinical response was defined as the number of participants who achieved modified World Health Organization's tumor response criteria of clinical complete response (complete disappearance of all clinically palpable detectable malignant disease and/or disappearance of radiological evidence of tumor in the breast and ipsilateral axillary lymph nodes) or clinical partial response (clinical evidence of a reduction in total tumor size of >= 50% in the overall sum of the products of diameters of breast and axillary lesions), divided by the number of randomized participants in that arm.
    Time Frame after the last dose of either ixabepilone or paclitaxel (at 12 weeks) but before surgery (4-6 weeks after the last dose of 12 weeks of therapy)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 148 147
    Number (90% Confidence Interval) [Percentage of Participants]
    81.1
    54.8%
    77.6
    52.8%
    3. Secondary Outcome
    Title Percentage of Participants Requiring Breast Conservation Surgery
    Description Number of randomized participants requiring breast conservation surgery following study treatment.
    Time Frame at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 148 147
    Number (90% Confidence Interval) [Percentage of Participants]
    41.9
    28.3%
    32.7
    22.2%
    4. Secondary Outcome
    Title Percentage of Participants Achieving Combined pCR and Minimal Residual Cancer Burden (RCB) 1
    Description Combined pCR and RCB-1 was defined as participants with no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of DCIS in the breast plus subjects with RCB-1 following the RCB calculation based on data entered by the investigator sites in each arm.
    Time Frame at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 148 147
    Number (90% Confidence Interval) [Percentage of Participants]
    30.4
    20.5%
    33.3
    22.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6186
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5806
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.86
    Confidence Interval (2-Sided) 90%
    0.56 to 1.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter difference
    Estimated Value -2.5
    Confidence Interval (2-Sided) 90%
    -11 to 6.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference in pCR/RCB-I rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.
    5. Secondary Outcome
    Title Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR
    Description Relevance of biomarker in differentiation between ixabepilone & paclitaxel evaluated by logistic regression with pCR as response. Statistical analyses include: 1) the likelihood ratio test between the full model (PCR~Biomarker:Treatment:estrogen receptor [ER]) & reduced model (PCR~Treatment:ER); 2) the likelihood ratio test between the full model (PCR~Biomarker:Treatment) & reduced model (PCR~Biomarker+Treatment); 3) the contrast of the interaction between treatment & biomarker expression within ER Negative subjects from the full model(PCR~Biomarker:Treatment:ER). A:B represents A,B & A*B.
    Time Frame pCR evaluated at time of surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Randomized Participants
    Arm/Group Description
    Measure Participants 295
    ABCB1 (209993_at)
    245
    165.5%
    ABCB1 /// ABCB4 (209994_s_at)
    245
    165.5%
    BRCA1 (211851_x_at)
    245
    165.5%
    BRCA1 (204531_s_at)
    245
    165.5%
    ERCC1 (203719_at)
    245
    165.5%
    ERCC1 (203720_s_at)
    245
    165.5%
    GTSE1 (204315_s_at)
    245
    165.5%
    GTSE1 (204317_at)
    245
    165.5%
    GTSE1 (215942_s_at)
    245
    165.5%
    GTSE1 (204318_s_at)
    245
    165.5%
    GTSE1 (211040_x_at)
    245
    165.5%
    KLK10 (209792_s_at)
    245
    165.5%
    KLK10 (215808_at)
    245
    165.5%
    KLK5 (222242_s_at)
    245
    165.5%
    KLK6 (204733_at)
    245
    165.5%
    RRM1 (201476_s_at)
    245
    165.5%
    RRM1 (201477_s_at)
    245
    165.5%
    TUBB (211714_x_at)
    245
    165.5%
    TUBB (212320_at)
    245
    165.5%
    TUBB (209026_x_at)
    245
    165.5%
    TUBB1 (208601_s_at)
    245
    165.5%
    TUBB2A (204141_at)
    245
    165.5%
    TUBB2A /// TUBB2B (209372_x_at)
    245
    165.5%
    TUBB2B (214023_x_at)
    245
    165.5%
    TUBB2C (208977_x_at)
    245
    165.5%
    TUBB2C (213726_x_at)
    245
    165.5%
    TUBB4 (212664_at)
    245
    165.5%
    TUBB6 (209191_at)
    245
    165.5%
    TYMS (202589_at)
    245
    165.5%
    TYMS (217684_at)
    245
    165.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ABCB1 (209993_at)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4115
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ABCB1 209993_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1629
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ABCB1 209993_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5074
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ABCB1 /// ABCB4 209994_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5530
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ABCB1 /// ABCB4 209994_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1845
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ABCB1 /// ABCB4 209994_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3538
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments BRCA1 211851_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9751
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments BRCA1 211851_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8874
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments BRCA1 211851_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6907
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments BRCA1 204531_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8052
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments BRCA1 204531_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5031
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments BRCA1 204531_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7588
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ERCC1 203719_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1542
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ERCC1 203719_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0235
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ERCC1 203719_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3612
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ERCC1 203720_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1840
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ERCC1 203720_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0942
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ERCC1 203720_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5327
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204315_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8847
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204315_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8947
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204315_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4085
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204317_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1119
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204317_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0250
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204317_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3569
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 215942_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4103
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 215942_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1490
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 215942_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5590
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204318_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4796
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204318_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2794
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204318_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1646
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 211040_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0782
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 211040_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1407
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 211040_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2369
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK10 209792_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7756
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK10 209792_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2623
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK10 209792_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3147
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK10 215808_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2885
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK10 215808_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7187
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK10 215808_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6017
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK5 222242_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4500
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK5 222242_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0952
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK5 222242_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7069
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK6 204733_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4767
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK6 204733_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6191
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK6 204733_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5276
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments RRM1 201476_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3323
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments RRM1 201476_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1025
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments RRM1 201476_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1715
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments RRM1 201477_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1070
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments RRM1 201477_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2751
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments RRM1 201477_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0276
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 211714_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1689
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 211714_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0769
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 211714_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1058
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 212320_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6406
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 212320_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1733
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 212320_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2631
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 209026_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2170
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 209026_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0868
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 209026_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1117
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB1 (208601_s_at)
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4943
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB1 208601_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5190
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB1 208601_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7350
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2A 204141_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3820
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2A 204141_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9290
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2A 204141_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0699
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2A /// TUBB2B 209372_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3515
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2A /// TUBB2B 209372_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2128
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2A /// TUBB2B 209372_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1275
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2B 214023_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2158
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2B 214023_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0266
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2B 214023_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3636
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2C 208977_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9479
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2C 208977_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3753
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2C 208977_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5477
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2C 213726_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4760
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2C 213726_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3314
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2C 213726_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1005
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB4 212664_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1180
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB4 212664_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1580
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB4 212664_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4385
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB6 209191_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7324
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB6 209191_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2657
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB6 209191_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5637
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TYMS 202589_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4473
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TYMS 202589_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3292
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TYMS 202589_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2054
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TYMS 217684_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5226
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TYMS 217684_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1720
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TYMS 217684_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3346
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    6. Secondary Outcome
    Title Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1
    Description Relevance of biomarker in differentiation between ixabepilone & paclitaxel evaluated by logistic regression with pCR/RCB1 as response. Statistical analyses include: 1) likelihood ratio test between the full model (pCR/RCB1~Biomarker:Treatment: ER) & reduced model (pCR/RCB1~Treatment:ER); 2) likelihood ratio test between the full model (pCR/RCB1 Biomarker:Treatment) & reduced model (pCR/RCB1~Biomarker+Treatment); 3) contrast of the interaction between treatment & biomarker expression within ER Negative subjects from the full model (pCR/RCB1~Biomarker:Treatment:ER). A:B represents A,B & A*B.
    Time Frame pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Randomized Participants
    Arm/Group Description
    Measure Participants 295
    ABCB1 (209993_at)
    245
    165.5%
    ABCB1 /// ABCB4 (209994_s_at)
    245
    165.5%
    BRCA1 (211851_x_at)
    245
    165.5%
    BRCA1 (204531_s_at)
    245
    165.5%
    ERCC1 (203719_at)
    245
    165.5%
    ERCC1 (203720_s_at)
    245
    165.5%
    GTSE1 (204315_s_at)
    245
    165.5%
    GTSE1 (204317_at)
    245
    165.5%
    GTSE1 (215942_s_at)
    245
    165.5%
    GTSE1 (204318_s_at)
    245
    165.5%
    GTSE1 (211040_x_at)
    245
    165.5%
    KLK10 (209792_s_at)
    245
    165.5%
    KLK10 (215808_at)
    245
    165.5%
    KLK5 (222242_s_at)
    245
    165.5%
    KLK6 (204733_at)
    245
    165.5%
    RRM1 (201476_s_at)
    245
    165.5%
    RRM1 (201477_s_at)
    245
    165.5%
    TUBB (211714_x_at)
    245
    165.5%
    TUBB (212320_at)
    245
    165.5%
    TUBB (209026_x_at)
    245
    165.5%
    TUBB1 (208601_s_at)
    245
    165.5%
    TUBB2A (204141_at)
    245
    165.5%
    TUBB2A /// TUBB2B (209372_x_at)
    245
    165.5%
    TUBB2B (214023_x_at)
    245
    165.5%
    TUBB2C (208977_x_at)
    245
    165.5%
    TUBB2C (213726_x_at)
    245
    165.5%
    TUBB4 (212664_at)
    245
    165.5%
    TUBB6 (209191_at)
    245
    165.5%
    TYMS (202589_at)
    245
    165.5%
    TYMS (217684_at)
    245
    165.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ABCB1 209993_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5604
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ABCB1 209993_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2715
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ABCB1 209993_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5268
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ABCB1 /// ABCB4 209994_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6058
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ABCB1 /// ABCB4 209994_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1918
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ABCB1 /// ABCB4 209994_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6712
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments BRCA1 211851_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9195
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments BRCA1 211851_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7021
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments BRCA1 211851_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3910
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments BRCA1 204531_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2909
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments BRCA1 204531_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3336
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments BRCA1 204531_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2360
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ERCC1 203719_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0281
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ERCC1 203719_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0434
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ERCC1 203719_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0283
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ERCC1 203720_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0151
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ERCC1 203720_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1999
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments ERCC1 203720_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0146
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204315_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1185
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204315_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8705
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204315_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0284
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204317_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0399
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204317_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0136
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204317_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0576
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 215942_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2245
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 215942_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1388
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 215942_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0692
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204318_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1058
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204318_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2688
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 204318_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0192
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 211040_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0033
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 211040_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2053
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments GTSE1 211040_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0032
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK10 209792_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6783
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK10 209792_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1630
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK10 209792_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2944
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK10 215808_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3727
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK10 215808_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8796
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK10 215808_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8344
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK5 222242_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2700
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK5 222242_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2624
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK5 222242_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0830
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK6 204733_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0849
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK6 204733_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6578
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments KLK6 204733_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0396
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments RRM1 201476_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1657
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments RRM1 201476_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0675
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments RRM1 201476_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1071
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments RRM1 201477_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0142
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments RRM1 201477_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2465
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments RRM1 201477_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 211714_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1231
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 211714_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0849
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 211714_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2740
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 212320_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2383
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 212320_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0644
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 212320_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2866
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 209026_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1259
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 209026_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0718
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB 209026_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3170
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB1 208601_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7844
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB1 208601_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4688
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB1 208601_s_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8553
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2A 204141_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6926
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2A 204141_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2222
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2A 204141_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4676
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2A /// TUBB2B 209372_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2036
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2A /// TUBB2B 209372_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4197
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2A /// TUBB2B 209372_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0776
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2B 214023_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4076
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2B 214023_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0629
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2B 214023_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2547
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2C 208977_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7125
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2C 208977_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6001
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2C 208977_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5398
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2C 213726_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3970
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2C 213726_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5085
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB2C 213726_x_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1213
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB4 212664_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0999
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB4 212664_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1201
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB4 212664_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1172
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB6 209191_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6596
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB6 209191_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3289
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TUBB6 209191_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3657
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TYMS 202589_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0275
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TYMS 202589_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3946
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TYMS 202589_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0074
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TYMS 217684_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2341
    Comments P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TYMS 217684_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0933
    Comments P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection Ixabepilone
    Comments TYMS 217684_at
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2016
    Comments P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)
    Method Regression, Logistic
    Comments p-value not adjusted for multiple comparison
    7. Secondary Outcome
    Title Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-Specified Thresholds
    Description Percentage of participants with pCR in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.
    Time Frame : pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.

    Outcome Measure Data

    Analysis Population Description
    Randomized participants with non-missing pCR and biomarker expression
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 111 117
    Mem+Cyto Threshold/Negative Biomarker Status
    0.143
    0.1%
    0.288
    0.2%
    Mem+Cyto Threshold/Positive Biomarker Status
    0.323
    0.2%
    0.259
    0.2%
    Mem Threshold/Negative Biomarker Status
    0.228
    0.2%
    0.284
    0.2%
    Mem Threshold/Negative Biomarker Status
    0.316
    0.2%
    0.2
    0.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments Mem+Cyto Threshold/Negative Biomarker Status
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference (bootstrap method)
    Estimated Value -0.145
    Confidence Interval (2-Sided) 90%
    -0.27 to -0.017
    Parameter Dispersion Type:
    Value:
    Estimation Comments ixabepilone - paclitaxel
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments Mem+Cyto Threshold/Positive Biomarker STatus
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference (bootstrap method)
    Estimated Value 0.064
    Confidence Interval (2-Sided) 90%
    -0.064 to 0.197
    Parameter Dispersion Type:
    Value:
    Estimation Comments ixabepilone - paclitaxel
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments Membrane Threshold/Negative Biomarker Status
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference (bootstrap method)
    Estimated Value -0.056
    Confidence Interval (2-Sided) 90%
    -0.152 to 0.046
    Parameter Dispersion Type:
    Value:
    Estimation Comments ixabepilone - paclitaxel
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments Membrane Threshold/Positive Biomarker Status
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference (bootstrap method)
    Estimated Value 0.116
    Confidence Interval (2-Sided) 90%
    -0.13 to 0.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments ixabepilone - paclitaxel
    8. Secondary Outcome
    Title Percentage of Participants With pCR/RCB1 and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds
    Description Percentage of participants with pCR/RCB1 in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score .
    Time Frame pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.

    Outcome Measure Data

    Analysis Population Description
    Randomized participants with non-missing pCR/RCB1 and biomarker expression
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 111 117
    Mem+Cyto Threshold/Negative Biomarker Status
    0.224
    0.2%
    0.339
    0.2%
    Mem+Cyto Threshold/Positive Biomarker Status
    0.371
    0.3%
    0.362
    0.2%
    Mem Threshold/Negative Biomarker Status
    0.304
    0.2%
    0.363
    0.2%
    Mem Threshold/Negative Biomarker Status
    0.316
    0.2%
    0.267
    0.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments Mem+Cyto/Negative Biomarker Status
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference (bootstrap method)
    Estimated Value -0.114
    Confidence Interval (2-Sided) 90%
    -0.258 to 0.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments ixabepilone - paclitaxel
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments Mem+Cyto Threshold/Positive Biomarker Status
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter DIfference (bootstrap method)
    Estimated Value 0.009
    Confidence Interval (2-Sided) 90%
    -0.137 to 0.155
    Parameter Dispersion Type:
    Value:
    Estimation Comments ixabepilone - paclitaxel
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments Membrane Threshold/Negative Biomarker Status
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference (bootstrap method)
    Estimated Value -0.058
    Confidence Interval (2-Sided) 90%
    -0.167 to 0.053
    Parameter Dispersion Type:
    Value:
    Estimation Comments ixabepilone - paclitaxel
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments Membrane Threshold/Positive Biomarker Status
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference (bootstrap method)
    Estimated Value 0.049
    Confidence Interval (2-Sided) 90%
    -0.227 to 0.309
    Parameter Dispersion Type:
    Value:
    Estimation Comments ixabepilone - paclitaxel
    9. Secondary Outcome
    Title Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds, Estrogen-Receptor (ER) Negative Participants
    Description Percentage of ER negative participants with pCR and MDR1 immunohistochemistry (IHC) positivity using 2 pre-specified thresholds, stratified by biomarker status. The first pre-specified threshold for MDR1-positivity (Mem)=Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.
    Time Frame pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.

    Outcome Measure Data

    Analysis Population Description
    Randomized estrogen negative participants with non-missing pCR and biomarker expression
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 64 70
    Mem+Cyto Threshold/Negative Biomarker Status
    0.192
    0.1%
    0.483
    0.3%
    Mem+Cyto Threshold/Positive Biomarker Status
    0.447
    0.3%
    0.341
    0.2%
    Mem Threshold/Negative Biomarker Status
    0.327
    0.2%
    0.417
    0.3%
    Mem Threshold/Negative Biomarker Status
    0.417
    0.3%
    0.3
    0.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments Mem+Cyto Threshold/Negative Biomarker Status
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference (bootstrap method)
    Estimated Value -0.29
    Confidence Interval (2-Sided) 90%
    -0.482 to -0.094
    Parameter Dispersion Type:
    Value:
    Estimation Comments ixabepilone - paclitaxel
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments Mem+Cyto Threshold/Positive Biomarker Status
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference (boostrap method)
    Estimated Value 0.106
    Confidence Interval (2-Sided) 90%
    -0.073 to 0.291
    Parameter Dispersion Type:
    Value:
    Estimation Comments ixabepilone - paclitaxel
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments Membrane Threshold/Negative Biomarker Status
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference (bootstrap method)
    Estimated Value -0.09
    Confidence Interval (2-Sided) 90%
    -0.236 to 0.067
    Parameter Dispersion Type:
    Value:
    Estimation Comments ixabepilone - paclitaxel
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Ixabepilone, Paclitaxel
    Comments Mem+Cyto Threshold/Positive Biomarker Status
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference (bootsrap method)
    Estimated Value 0.117
    Confidence Interval (2-Sided) 90%
    -0.218 to 0.469
    Parameter Dispersion Type:
    Value:
    Estimation Comments ixabepilone - paclitaxel
    10. Secondary Outcome
    Title Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants)
    Description Percentage of participants having the following optimal biomarker thresholds as computed from the cross-validation method (cutoff of biomarker positive [with 90% confidence interval by Bootstrap method]): Beta 3 Tubulin IHC (45.866 [5, 83.9]); TACC3 mRNA (6.714 [6.312, 7.192]); CAPG mRNA (6.739 [5.728, 7.298]). Optimal thresholds for a 20-gene model and a 26-gene model were also planned; however, these were not determined because preliminary analyses did not indicate that they would not differentiate pCR rates between treatment arm.
    Time Frame pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy and mRNA samples obtained prior to treatment

    Outcome Measure Data

    Analysis Population Description
    Randomized participants with non-missing pCR and biomarker expressions. n=the number of participants with specific biomarker expression.
    Arm/Group Title Randomized Participants
    Arm/Group Description Randomized Participants with non-missing pCR and biomarker expression
    Measure Participants 245
    Beta 3 Tubulin IHC (n=231)
    0.394
    0.3%
    Beta 3 Tubulin IHC H-Score (n=231)
    0.299
    0.2%
    Beta 3 Tubulin mRNA (n=245)
    0.392
    0.3%
    TACC3 mRNA (n=245)
    0.514
    0.3%
    CAPG mRNA (n=245)
    0.486
    0.3%
    11. Secondary Outcome
    Title Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants
    Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. By Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grades
    Time Frame prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 148 147
    Death
    0
    0%
    2
    1.4%
    Any SAE, Grade (Gr) 1 (mild)
    0
    0%
    0
    0%
    Any SAE, Grade 2 (moderate)
    2
    1.4%
    0
    0%
    Any SAE, Grade 3 (severe)
    8
    5.4%
    6
    4.1%
    Any SAE, Grade 4 (life-threatening)
    6
    4.1%
    3
    2%
    Any SAE, Grade 5 (death)
    0
    0%
    1
    0.7%
    Any SAE, Grade Unknown
    1
    0.7%
    1
    0.7%
    AE Leading to Discontinuation, Grade 1 (mild)
    0
    0%
    0
    0%
    AE Leading to Discontinuation, Grade 2 (moderate)
    3
    2%
    8
    5.4%
    AE Leading to Discontinuation, Grade 3 (severe)
    7
    4.7%
    4
    2.7%
    AE Leading to Discon, Grade 4 (life-threatening)
    4
    2.7%
    1
    0.7%
    Any Drug-Related AE, Grade 1 (mild)
    24
    16.2%
    40
    27.2%
    Any Drug-Related AE, Grade 2 (moderate)
    45
    30.4%
    54
    36.7%
    Any Drug-Related AE, Grade 3 (severe)
    46
    31.1%
    24
    16.3%
    Any Drug-Related AE, Grade 4 (life-threatening)
    15
    10.1%
    3
    2%
    TNAE: Peripheral Sensory Neuropathy,Grade 1 (mild)
    36
    24.3%
    46
    31.3%
    TNAE:Peripheral Sensory Neuropathy,Gr 2 (moderate)
    21
    14.2%
    21
    14.3%
    TNAE: Peripheral Sensory Neuropathy, Gr 3 (severe)
    6
    4.1%
    5
    3.4%
    TNAE: Peripheral Sensory Neuropathy, Grade 4
    0
    0%
    0
    0%
    TNAE: Myalgia, Grade 1 (mild)
    18
    12.2%
    13
    8.8%
    TNAE: Myalgia, Grade 2 (moderate)
    19
    12.8%
    5
    3.4%
    TNAE: Myalgia, Grade 3 (severe)
    4
    2.7%
    1
    0.7%
    TNAE: Myalgia, Grade 4 (life-threatening)
    0
    0%
    0
    0%
    TNAE: Arthralgia, Grade 1 (mild)
    15
    10.1%
    12
    8.2%
    TNAE: Arthralgia, Grade 2 (moderate)
    18
    12.2%
    2
    1.4%
    TNAE: Arthralgia, Grade 3 (severe)
    1
    0.7%
    0
    0%
    TNAE: Arthralgia, Grade 4 (life-threatening)
    0
    0%
    0
    0%
    TNAE: Bone Pain, Grade 1 (mild)
    10
    6.8%
    5
    3.4%
    TNAE: Bone Pain, Grade 2 (moderate)
    11
    7.4%
    1
    0.7%
    TNAE: Bone Pain, Grade 3 (severe)
    7
    4.7%
    0
    0%
    TNAE: Bone Pain, Grade 4 (life-threatening)
    0
    0%
    0
    0%
    TNAE: Fatigue, Grade 1 (mild)
    11
    7.4%
    12
    8.2%
    TNAE: Fatigue, Grade 2 (moderate)
    11
    7.4%
    10
    6.8%
    TNAE: Fatigue, Grade 3 (severe)
    5
    3.4%
    2
    1.4%
    TNAE: Fatigue, Grade 4 (life-threatening)
    0
    0%
    0
    0%
    TNAE: Diarrhea, Grade 1 (mild)
    19
    12.8%
    11
    7.5%
    TNAE: Diarrhea, Grade 2
    4
    2.7%
    5
    3.4%
    TNAE: Diarrhea, Grade 3 (severe)
    2
    1.4%
    2
    1.4%
    TNAE: Diarrhea, Grade 4 (life-threatening)
    0
    0%
    0
    0%
    TNAE: Nausea, Grade 1 (mild)
    18
    12.2%
    16
    10.9%
    TNAE: Nausea, Grade 2
    6
    4.1%
    1
    0.7%
    TNAE: Nausea, Grade 3 (severe)
    1
    0.7%
    0
    0%
    TNAE: Nausea, Grade 4 (life-threatening)
    0
    0%
    0
    0%
    TNAE: Musculoskeletal Pain, Grade 1 (mild)
    9
    6.1%
    4
    2.7%
    TNAE: Musculoskeletal Pain, Grade 2 (moderate)
    5
    3.4%
    1
    0.7%
    TNAE: Musculoskeletal Pain, Grade 3 (severe)
    1
    0.7%
    1
    0.7%
    TNAE: Musculoskeletal Pain,Gr 4 (life-threatening)
    0
    0%
    0
    0%
    12. Secondary Outcome
    Title Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class
    Description MCT=musculoskeletal and connective tissue, GDASC=general disorders and administration site conditions, RTM=respiratory, thoracic and mediastinal disorders, NBMUCP=neoplasms benign, malignant and unspecified (including cysts and polyps). Drug related adverse events are those events with relationship to study therapy of certain, probable, possible or missing. Subjects may have more than one event within a class. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)
    Time Frame prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy

    Outcome Measure Data

    Analysis Population Description
    Ixabepilone- and Paclitaxel-treated participants
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 145 144
    Any Drug-Related AEs, Grade (Gr) 1
    5
    3.4%
    8
    5.4%
    Any Drug-Related AEs, Gr 2
    56
    37.8%
    69
    46.9%
    Any Drug-Related AEs, Gr 3
    55
    37.2%
    32
    21.8%
    Any Drug-Related AEs, Gr 4
    22
    14.9%
    23
    15.6%
    Any Drug-Related AEs, Gr 5
    0
    0%
    0
    0%
    Gastrointestinal Disorder AEs, Gr 1
    54
    36.5%
    52
    35.4%
    Gastrointestinal Disorder AEs, Gr 2
    42
    28.4%
    44
    29.9%
    Gastrointestinal Disorder AEs, Gr 3
    10
    6.8%
    6
    4.1%
    Gastrointestinal Disorder AEs, Gr 4
    0
    0%
    0
    0%
    Gastrointestinal Disorder AEs, Gr 5
    0
    0%
    0
    0%
    MCT Disorder AEs, Gr 1 (spell out)
    36
    24.3%
    28
    19%
    MCT Disorder AEs, Gr 2
    44
    29.7%
    12
    8.2%
    MCT Disorder AEs, Gr 3
    12
    8.1%
    3
    2%
    MCT Disorder AEs, Gr 4
    0
    0%
    0
    0%
    MCT Disorder AEs, Gr 5
    0
    0%
    0
    0%
    GDASC AEs, Gr 1 (spell out)
    51
    34.5%
    47
    32%
    GDASC AEs, Gr 2
    28
    18.9%
    23
    15.6%
    GDASC AEs, Gr 3
    9
    6.1%
    6
    4.1%
    GDASC AEs, Gr 4
    0
    0%
    0
    0%
    GDASC AEs, Gr 5
    0
    0%
    0
    0%
    Skin and Subcutaneous Tissue Disorder AEs, Gr 1
    25
    16.9%
    29
    19.7%
    Skin and Subcutaneous Tissue Disorder AEs, Gr 2
    60
    40.5%
    70
    47.6%
    Skin and Subcutaneous Tissue Disorder AEs, Gr 3
    3
    2%
    2
    1.4%
    Skin and Subcutaneous Tissue Disorder AEs, Gr 4
    0
    0%
    0
    0%
    Skin and Subcutaneous Tissue Disorder AEs, Gr 5
    0
    0%
    0
    0%
    Nervous System Disorder AEs, Gr 1
    45
    30.4%
    52
    35.4%
    Nervous System Disorder AEs, Gr 2
    27
    18.2%
    25
    17%
    Nervous System Disorder AEs, Gr 3
    7
    4.7%
    6
    4.1%
    Nervous System Disorder AEs, Gr 4
    0
    0%
    1
    0.7%
    Nervous System Disorder AEs, Gr 5
    0
    0%
    0
    0%
    Blood & Lymphatic System Disorder AEs, Gr 1
    4
    2.7%
    2
    1.4%
    Blood & Lymphatic System Disorder AEs, Gr 2
    13
    8.8%
    15
    10.2%
    Blood & Lymphatic System Disorder AEs, Gr 3
    20
    13.5%
    15
    10.2%
    Blood & Lymphatic System Disorder AEs, Gr 4
    15
    10.1%
    21
    14.3%
    Blood & Lymphatic System Disorder AEs, Gr 5
    0
    0%
    0
    0%
    Laboratory Investigation AEs, Gr 1
    11
    7.4%
    5
    3.4%
    Laboratory Investigation AEs, Gr 2
    5
    3.4%
    10
    6.8%
    Laboratory Investigation AEs, Gr 3
    7
    4.7%
    9
    6.1%
    Laboratory Investigation AEs, Gr 4
    6
    4.1%
    3
    2%
    Laboratory Investigation AEs, Gr 5
    0
    0%
    0
    0%
    Metabolism & Nutrition Disorder AEs, Gr 1
    13
    8.8%
    8
    5.4%
    Metabolism & Nutrition Disorder AEs, Gr 2
    9
    6.1%
    8
    5.4%
    Metabolism & Nutrition Disorder AEs, Gr 3
    0
    0%
    1
    0.7%
    Metabolism & Nutrition Disorder AEs, Gr 4
    0
    0%
    0
    0%
    Metabolism & Nutrition Disorder AEs, Gr 5
    0
    0%
    0
    0%
    RTM Disorder AEs, Gr 1 (spell out)
    18
    12.2%
    17
    11.6%
    RTM Disorder AEs, Gr 2
    1
    0.7%
    6
    4.1%
    RTM Disorder AEs, Gr 3
    1
    0.7%
    1
    0.7%
    RTM Disorder AEs, Gr 4
    1
    0.7%
    3
    2%
    RTM Disorder AEs, Gr 5
    0
    0%
    0
    0%
    Infections & Infestations AEs, Gr 1
    9
    6.1%
    6
    4.1%
    Infections & Infestations AEs, Gr 2
    8
    5.4%
    7
    4.8%
    Infections & Infestations AEs, Gr 3
    3
    2%
    1
    0.7%
    Infections & Infestations AEs, Gr 4
    0
    0%
    1
    0.7%
    Infections & Infestations, Gr 5
    0
    0%
    0
    0%
    Psychiatric Disorder AEs, Gr 1
    13
    8.8%
    15
    10.2%
    Psychiatric Disorder AEs, Gr 2
    3
    2%
    2
    1.4%
    Psychiatric Disorder AEs, Gr 3
    2
    1.4%
    0
    0%
    Psychiatric Disorder AEs, Gr 4
    0
    0%
    0
    0%
    Psychiatric Disorder AEs, Gr 5
    0
    0%
    0
    0%
    Vascular Disorder AEs, Gr 1
    12
    8.1%
    17
    11.6%
    Vascular Disorder AEs, Gr 2
    5
    3.4%
    3
    2%
    Vascular Disorder AEs, Gr 3
    1
    0.7%
    0
    0%
    Vascular Disorder AEs, Gr 4
    0
    0%
    2
    1.4%
    Vascular Disorder AEs, Gr 5
    0
    0%
    0
    0%
    Eye Disorder AEs, Gr 1
    14
    9.5%
    10
    6.8%
    Eye Disorder AEs, Gr 2
    1
    0.7%
    1
    0.7%
    Eye Disorder AEs, Gr 3
    0
    0%
    0
    0%
    Eye Disorder AEs, Gr 4
    0
    0%
    0
    0%
    Eye Disorder AEs, Gr 5
    0
    0%
    0
    0%
    Immune System Disorder AEs, Gr 1
    3
    2%
    2
    1.4%
    Immune System Disorder AEs, Gr 2
    2
    1.4%
    0
    0%
    Immune System Disorder AEs, Gr 3
    0
    0%
    0
    0%
    Immune System Disorder AEs, Gr 4
    2
    1.4%
    0
    0%
    Immune System Disorder AEs, Gr 5
    0
    0%
    0
    0%
    Reproductive System and Breast Disorders, Gr 1
    2
    1.4%
    1
    0.7%
    Reproductive System and Breast Disorders, Gr 2
    3
    2%
    1
    0.7%
    Reproductive System and Breast Disorders, Gr 3
    1
    0.7%
    0
    0%
    Reproductive System and Breast Disorders, Gr 4
    0
    0%
    0
    0%
    Reproductive System and Breast Disorders, Gr 5
    0
    0%
    0
    0%
    Cardiac Disorder AEs, Gr 1
    1
    0.7%
    3
    2%
    Cardiac Disorder AEs, Gr 2
    0
    0%
    2
    1.4%
    Cardiac Disorder AEs, Gr 3
    3
    2%
    0
    0%
    Cardiac Disorder AEs, Gr 4
    0
    0%
    1
    0.7%
    Cardiac Disorder AEs, Gr 5
    0
    0%
    0
    0%
    Ear and Labyrinth Disorder AEs, Gr 1
    1
    0.7%
    4
    2.7%
    Ear and Labyrinth Disorder AEs, Gr 2
    3
    2%
    0
    0%
    Ear and Labyrinth Disorder AEs, Gr 3
    0
    0%
    0
    0%
    Ear and Labyrinth Disorder AEs, Gr 4
    0
    0%
    0
    0%
    Ear and Labyrinth Disorder AEs, Gr 5
    0
    0%
    0
    0%
    Renal and Urinary Disorder AEs, Gr 1
    2
    1.4%
    1
    0.7%
    Renal and Urinary Disorder AEs, Gr 2
    0
    0%
    0
    0%
    Renal and Urinary Disorder AEs, Gr 3
    0
    0%
    0
    0%
    Renal and Urinary Disorder AEs, Gr 4
    0
    0%
    0
    0%
    Renal and Urinary Disorder AEs, Gr 5
    0
    0%
    0
    0%
    Injury, Poisoning&Procedural Complication AEs,Gr 1
    0
    0%
    1
    0.7%
    Injury, Poisoning&Procedural Complication AEs,Gr 2
    1
    0.7%
    0
    0%
    Injury, Poisoning&Procedural Complication AEs,Gr 3
    0
    0%
    0
    0%
    Injury, Poisoning&Procedural Complication AEs,Gr 4
    0
    0%
    0
    0%
    Injury, Poisoning&Procedural Complication AEs,Gr 5
    0
    0%
    0
    0%
    Hepatobiliary Disorder AEs, Gr 1
    0
    0%
    0
    0%
    Hepatobiliary Disorder AEs, Gr 2
    0
    0%
    0
    0%
    Hepatobiliary Disorder AEs, Gr 3
    0
    0%
    0
    0%
    Hepatobiliary Disorder AEs, Gr 4
    0
    0%
    1
    0.7%
    Hepatobiliary Disorder AEs, Gr 5
    0
    0%
    0
    0%
    NBMUCP AEs, Gr 1
    0
    0%
    0
    0%
    NBMUCP AEs, Gr 2
    0
    0%
    1
    0.7%
    NBMUCP AEs, Gr 3
    0
    0%
    0
    0%
    NBMUCP AEs, Gr 4
    0
    0%
    0
    0%
    NBMUCP AEs, Gr 5
    0
    0%
    0
    0%
    13. Secondary Outcome
    Title On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase
    Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)
    Time Frame prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase

    Outcome Measure Data

    Analysis Population Description
    Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded.
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 143 143
    White Blood Cells (WBC), Grade 0
    32
    21.6%
    32
    21.8%
    WBC, Grade 1
    27
    18.2%
    63
    42.9%
    WBC, Grade 2
    32
    21.6%
    41
    27.9%
    WBC, Grade 3
    44
    29.7%
    7
    4.8%
    WBC, Grade 4
    8
    5.4%
    0
    0%
    WBC, Grade 1-4
    111
    75%
    111
    75.5%
    WBC, Grade 3-4
    52
    35.1%
    7
    4.8%
    Absolute Neutrophil Count (ANC), Grade 0
    33
    22.3%
    66
    44.9%
    ANC, Grade 1
    23
    15.5%
    41
    27.9%
    ANC, Grade 2
    28
    18.9%
    24
    16.3%
    ANC, Grade 3
    36
    24.3%
    12
    8.2%
    ANC, Grade 4
    23
    15.5%
    0
    0%
    ANC, Grade 1-4
    110
    74.3%
    77
    52.4%
    ANC, Grade 3-4
    59
    39.9%
    12
    8.2%
    Platelets, Grade 0
    109
    73.6%
    134
    91.2%
    Platelets, Grade 1
    33
    22.3%
    6
    4.1%
    Platelets, Grade 2
    0
    0%
    2
    1.4%
    Platelets, Grade 3
    1
    0.7%
    1
    0.7%
    Platelets, Grade 4
    0
    0%
    0
    0%
    Platelets, Grade 1-4
    34
    23%
    9
    6.1%
    Platelets, Grade 3-4
    1
    0.7%
    1
    0.7%
    Hemoglobin, Grade 0
    13
    8.8%
    8
    5.4%
    Hemoglobin, Grade 1
    77
    52%
    91
    61.9%
    Hemoglobin, Grade 2
    51
    34.5%
    37
    25.2%
    Hemoglobin, Grade 3
    2
    1.4%
    6
    4.1%
    Hemoglobin, Grade 4
    0
    0%
    1
    0.7%
    Hemoglobin, Grade 1-4
    130
    87.8%
    135
    91.8%
    Hemoglobin, Grade 3-4
    2
    1.4%
    7
    4.8%
    14. Primary Outcome
    Title Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations
    Description Beta III tubulin positivity determined by cross-validation method. Optimal cutoff: ≥46% tumor cells staining at 2 plus or 3 plus intensity (corresponding Beta III tubulin positivity=39.4%). Pre-specified cutoff of Beta III tubulin positivity: ≥50% 2plus or 3plus cells (corresponding prevalence=38.5%). Optimal cutoffs for TACC3 and CAPG positivity determined by cross-validation method: 6.889 and 6.844 [log2 normalized intensity units], respectively (corresponding to prevalence rates of 43.3% and 44.3%).
    Time Frame pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.

    Outcome Measure Data

    Analysis Population Description
    For all subgroups other than Beta-III positive/negative subgroup based on a pre-determined cutoff, results were estimated using a cross-validation method (a resampling based technique, making individual sample size [N] not applicable).
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 148 147
    Beta-III positive subgroup (cross-validation)
    35.9
    24.3%
    36.1
    24.6%
    Beta-III negative subgroup (cross-validation)
    17.4
    11.8%
    22.4
    15.2%
    Beta-III positive subgroup (n=43, 42)
    34.9
    23.6%
    35.7
    24.3%
    Beta-III negative subgroup (n=71, 75)
    18.3
    12.4%
    22.7
    15.4%
    TACC3 positive subgroup (cross-validation)
    30.1
    20.3%
    29.4
    20%
    TACC3 negative subgroup (cross-validation)
    19.8
    13.4%
    27.0
    18.4%
    CAPG positive subgroup (cross-validation)
    30.7
    20.7%
    35.3
    24%
    CAPG negative subgroup (cross-validation)
    20.4
    13.8%
    20.7
    14.1%
    15. Secondary Outcome
    Title On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase
    Description Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)
    Time Frame prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of study therapy during ixabepilone or paclitaxel treatment phase

    Outcome Measure Data

    Analysis Population Description
    Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded; n=number of participants with specific laboratory evaluation.
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 143 143
    ALT, Grade 0 (n=142, 140)
    72
    48.6%
    52
    35.4%
    ALT, Grade 1 (n=142, 140)
    54
    36.5%
    59
    40.1%
    ALT, Grade 2 (n=142, 140)
    13
    8.8%
    22
    15%
    ALT, Grade 3 (n=142, 140)
    3
    2%
    7
    4.8%
    ALT, Grade 4 (n=142, 140)
    0
    0%
    0
    0%
    ALT, Grade 1-4 (n=142, 140)
    70
    47.3%
    88
    59.9%
    ALT, Grade 3-4 (n=142, 140)
    3
    2%
    7
    4.8%
    AST, Grade 0 (n=141, 140)
    85
    57.4%
    64
    43.5%
    AST, Grade 1 (n=141, 140)
    51
    34.5%
    64
    43.5%
    AST, Grade 2 (n=141, 140)
    4
    2.7%
    9
    6.1%
    AST, Grade 3 (n=141, 140)
    1
    0.7%
    3
    2%
    AST, Grade 4 (n=141, 140)
    0
    0%
    0
    0%
    AST, Grade 1-4 (n=141, 140)
    56
    37.8%
    76
    51.7%
    AST, Grade 3-4 (n=141, 140)
    1
    0.7%
    3
    2%
    Alkaline Phosphatase, Grade 0 (n=141, 140)
    114
    77%
    117
    79.6%
    Alkaline Phosphatase, Grade 1 (n=141, 140)
    27
    18.2%
    23
    15.6%
    Alkaline Phosphatase, Grade 2 (n=141, 140)
    0
    0%
    0
    0%
    Alkaline Phosphatase, Grade 3 (n=141, 140)
    0
    0%
    0
    0%
    Alkaline Phosphatase, Grade 4 (n=141, 140)
    0
    0%
    0
    0%
    Alkaline Phosphatase, Grade 1-4 (n=141, 140)
    27
    18.2%
    23
    15.6%
    Alkaline Phosphatase, Grade 3-4 (n=141, 140)
    0
    0%
    0
    0%
    Total Bilirubin, Grade 0 (n=142, 140)
    137
    92.6%
    131
    89.1%
    Total Bilirubin, Grade 1 (n=142, 140)
    4
    2.7%
    8
    5.4%
    Total Bilirubin, Grade 2 (n=142, 140)
    0
    0%
    0
    0%
    Total Bilirubin, Grade 3 (n=142, 140)
    1
    0.7%
    0
    0%
    Total Bilirubin, Grade 4 (n=142, 140)
    0
    0%
    1
    0.7%
    Total Bilirubin, Grade 1-4 (n=142, 140)
    5
    3.4%
    9
    6.1%
    Total Bilirubin, Grade 3-4 (n=142, 140)
    1
    0.7%
    1
    0.7%
    16. Secondary Outcome
    Title On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase
    Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)
    Time Frame prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase

    Outcome Measure Data

    Analysis Population Description
    Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded.
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 142 139
    Creatinine, Grade 0
    136
    91.9%
    135
    91.8%
    Creatinine, Grade 1
    6
    4.1%
    3
    2%
    Creatinine, Grade 2
    0
    0%
    1
    0.7%
    Creatinine, Grade 3
    0
    0%
    0
    0%
    Creatinine, Grade 4
    0
    0%
    0
    0%
    Creatinine, Grade 1-4
    6
    4.1%
    4
    2.7%
    Creatinine, Grade 3-4
    0
    0%
    0
    0%
    17. Secondary Outcome
    Title Number of Participants by Dose for AC
    Description
    Time Frame 12 weeks (4 3-week cycles)

    Outcome Measure Data

    Analysis Population Description
    ixabepilone- and paclitaxel-treated participants
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 145 144
    Dose 1 (Week 3)
    145
    98%
    144
    98%
    Dose 2 (Week 6)
    145
    98%
    144
    98%
    Dose 3 (Week 9)
    145
    98%
    142
    96.6%
    Dose 4 (Week 12)
    143
    96.6%
    141
    95.9%
    18. Secondary Outcome
    Title Number of Participants by Dose for Ixabepilone/Paclitaxel
    Description
    Time Frame 12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)

    Outcome Measure Data

    Analysis Population Description
    ixabepilone- and paclitaxel-treated participants
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 145 144
    Dose 1 (Week 3, ixabepilone; Week 1 paclitaxel)
    145
    98%
    144
    98%
    Dose 2 (Week 6, ixabepilone; Week 2 paclitaxel)
    139
    93.9%
    142
    96.6%
    Dose 3 (Week 9, ixabepilone; Week 3 paclitaxel)
    130
    87.8%
    139
    94.6%
    Dose 4 (Week 12, ixabepilone; Week 4 paclitaxel)
    124
    83.8%
    139
    94.6%
    Dose 5 (Week 5 paclitaxel)
    0
    0%
    135
    91.8%
    Dose 6 (Week 6 paclitaxel)
    0
    0%
    135
    91.8%
    Dose 7 (Week 7 paclitaxel)
    0
    0%
    132
    89.8%
    Dose 8 (Week 8 paclitaxel)
    0
    0%
    131
    89.1%
    Dose 9 (Week 9 paclitaxel)
    0
    0%
    129
    87.8%
    Dose 10 (Week 10 paclitaxel)
    0
    0%
    128
    87.1%
    Dose 11 (Week 11 paclitaxel)
    0
    0%
    123
    83.7%
    Dose 12 (Week 12 paclitaxel)
    0
    0%
    118
    80.3%
    19. Secondary Outcome
    Title Reason for First Dose Reduction of AC
    Description
    Time Frame 12 weeks (4 3-week cycles)

    Outcome Measure Data

    Analysis Population Description
    ixabepilone- and paclitaxel-treated participants with at least 2 courses of AC
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 145 144
    Participants with at least 1 dose reduction of AC
    5
    3.4%
    7
    4.8%
    Adverse Event
    1
    0.7%
    3
    2%
    Hematologic Toxicity
    3
    2%
    3
    2%
    Non-Hematologic Toxicity
    0
    0%
    1
    0.7%
    Not Reported
    1
    0.7%
    0
    0%
    20. Secondary Outcome
    Title Reason for First Dose Reduction of Ixabepilone/Paclitaxel
    Description
    Time Frame 12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)

    Outcome Measure Data

    Analysis Population Description
    ixabepilone- and paclitaxel-treated participants with at least 2 courses of Ixabepilone/Paclitaxel
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 145 144
    Participants with at least 1 dose reduction
    18
    12.2%
    18
    12.2%
    Adverse Event
    10
    6.8%
    3
    2%
    Hematologic Toxicity
    2
    1.4%
    0
    0%
    Non-Hematologic Toxicity
    0
    0%
    4
    2.7%
    Not Reported
    1
    0.7%
    2
    1.4%
    Peripheral Neuropathy
    5
    3.4%
    9
    6.1%
    21. Secondary Outcome
    Title Number of Participants With Course Delay and Reason for Delay for AC
    Description
    Time Frame 12 weeks (4 3-week cycles)

    Outcome Measure Data

    Analysis Population Description
    ixabepilone- and paclitaxel-treated participants with at least 2 courses of AC
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 145 144
    Participants with at least 1 dose delay
    41
    27.7%
    43
    29.3%
    Administrative Reason
    5
    3.4%
    6
    4.1%
    Adverse Event
    6
    4.1%
    10
    6.8%
    Hematologic Toxicity
    17
    11.5%
    10
    6.8%
    Non-Hematologic Toxicity
    3
    2%
    2
    1.4%
    Not Reported
    14
    9.5%
    16
    10.9%
    Other
    3
    2%
    1
    0.7%
    Subject Request
    2
    1.4%
    0
    0%
    22. Secondary Outcome
    Title Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel
    Description
    Time Frame 12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)

    Outcome Measure Data

    Analysis Population Description
    ixabepilone- and paclitaxel-treated participants with at least 2 courses of Ixabepilone/Paclitaxel
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 145 144
    Participants with at least 1 dose delay
    31
    20.9%
    51
    34.7%
    Administrative Reason
    3
    2%
    5
    3.4%
    Adverse Event
    6
    4.1%
    15
    10.2%
    Hematologic Toxicity
    10
    6.8%
    15
    10.2%
    Non-Hematologic Toxicity
    0
    0%
    7
    4.8%
    Not Reported
    13
    8.8%
    8
    5.4%
    Other
    3
    2%
    8
    5.4%
    Peripheral Neuropathy
    0
    0%
    1
    0.7%
    Subject Request
    0
    0%
    3
    2%
    23. Primary Outcome
    Title Percentage of Participants Achieving Pathologic Complete Response (pCR) in 20- and 26-Gene Model Subgroups
    Description For each of the 2 biomarker sets (20-gene or 26-gene), a multi-gene model was built using penalized logistic regression on all pharmacogenomic evaluable subjects for each treatment arm separately. Receiver Operating Characteristic (ROC) plots for separate arm using 5 fold cross validation were generated. ROC for separate arms using cross over were also added. Further analysis on the multiple gene models (as mentioned in the SAP) was planned only based on the initial findings from the 2 ROC plots. For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.
    Time Frame pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.

    Outcome Measure Data

    Analysis Population Description
    For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    Measure Participants 0 0

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Adverse events are reported for randomized population.
    Arm/Group Title Ixabepilone Paclitaxel
    Arm/Group Description ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks) paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
    All Cause Mortality
    Ixabepilone Paclitaxel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Ixabepilone Paclitaxel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 17/145 (11.7%) 11/144 (7.6%)
    Blood and lymphatic system disorders
    ANAEMIA 0/145 (0%) 1/144 (0.7%)
    LEUKOPENIA 2/145 (1.4%) 0/144 (0%)
    NEUTROPENIA 1/145 (0.7%) 0/144 (0%)
    LEUKOCYTOSIS 1/145 (0.7%) 0/144 (0%)
    THROMBOCYTOPENIA 1/145 (0.7%) 0/144 (0%)
    FEBRILE NEUTROPENIA 1/145 (0.7%) 1/144 (0.7%)
    THROMBOTIC THROMBOCYTOPENIC PURPURA 0/145 (0%) 1/144 (0.7%)
    DISSEMINATED INTRAVASCULAR COAGULATION 0/145 (0%) 1/144 (0.7%)
    Cardiac disorders
    CARDIAC FAILURE 1/145 (0.7%) 0/144 (0%)
    ATRIAL FIBRILLATION 1/145 (0.7%) 0/144 (0%)
    CARDIO-RESPIRATORY ARREST 0/145 (0%) 1/144 (0.7%)
    Gastrointestinal disorders
    VOMITING 2/145 (1.4%) 0/144 (0%)
    DIARRHOEA 4/145 (2.8%) 0/144 (0%)
    ABDOMINAL PAIN 1/145 (0.7%) 0/144 (0%)
    GALLSTONE ILEUS 0/145 (0%) 1/144 (0.7%)
    General disorders
    FATIGUE 2/145 (1.4%) 1/144 (0.7%)
    PYREXIA 0/145 (0%) 3/144 (2.1%)
    SUDDEN DEATH 0/145 (0%) 1/144 (0.7%)
    OEDEMA PERIPHERAL 0/145 (0%) 1/144 (0.7%)
    Hepatobiliary disorders
    HYPERBILIRUBINAEMIA 0/145 (0%) 1/144 (0.7%)
    Immune system disorders
    ANAPHYLACTIC SHOCK 1/145 (0.7%) 0/144 (0%)
    ANAPHYLACTIC REACTION 1/145 (0.7%) 0/144 (0%)
    Infections and infestations
    SEPSIS 0/145 (0%) 1/144 (0.7%)
    PNEUMONIA 1/145 (0.7%) 1/144 (0.7%)
    URINARY TRACT INFECTION 0/145 (0%) 1/144 (0.7%)
    RESPIRATORY TRACT INFECTION 0/145 (0%) 1/144 (0.7%)
    Injury, poisoning and procedural complications
    OVERDOSE 3/145 (2.1%) 0/144 (0%)
    MEDICATION ERROR 0/145 (0%) 1/144 (0.7%)
    LOWER LIMB FRACTURE 1/145 (0.7%) 0/144 (0%)
    Investigations
    HAEMOGLOBIN DECREASED 0/145 (0%) 1/144 (0.7%)
    Metabolism and nutrition disorders
    HYPOALBUMINAEMIA 0/145 (0%) 1/144 (0.7%)
    Musculoskeletal and connective tissue disorders
    MYALGIA 1/145 (0.7%) 1/144 (0.7%)
    Nervous system disorders
    HEADACHE 0/145 (0%) 1/144 (0.7%)
    SOMNOLENCE 1/145 (0.7%) 0/144 (0%)
    ENCEPHALOPATHY 1/145 (0.7%) 0/144 (0%)
    CRANIAL NEUROPATHY 0/145 (0%) 1/144 (0.7%)
    NEUROPATHY PERIPHERAL 1/145 (0.7%) 0/144 (0%)
    CEREBRAL VENOUS THROMBOSIS 0/145 (0%) 1/144 (0.7%)
    PERIPHERAL SENSORY NEUROPATHY 2/145 (1.4%) 1/144 (0.7%)
    DEPRESSED LEVEL OF CONSCIOUSNESS 1/145 (0.7%) 0/144 (0%)
    Respiratory, thoracic and mediastinal disorders
    COUGH 1/145 (0.7%) 0/144 (0%)
    ASTHMA 0/145 (0%) 1/144 (0.7%)
    HYPOXIA 0/145 (0%) 1/144 (0.7%)
    DYSPNOEA 0/145 (0%) 3/144 (2.1%)
    PNEUMONITIS 0/145 (0%) 1/144 (0.7%)
    OROPHARYNGEAL PAIN 0/145 (0%) 1/144 (0.7%)
    PULMONARY EMBOLISM 1/145 (0.7%) 1/144 (0.7%)
    NON-CARDIOGENIC PULMONARY OEDEMA 0/145 (0%) 1/144 (0.7%)
    ACUTE RESPIRATORY DISTRESS SYNDROME 0/145 (0%) 1/144 (0.7%)
    Skin and subcutaneous tissue disorders
    RASH 1/145 (0.7%) 0/144 (0%)
    URTICARIA 1/145 (0.7%) 0/144 (0%)
    EXFOLIATIVE RASH 0/145 (0%) 1/144 (0.7%)
    Vascular disorders
    HYPOTENSION 1/145 (0.7%) 1/144 (0.7%)
    PERIPHERAL ISCHAEMIA 0/145 (0%) 1/144 (0.7%)
    Other (Not Including Serious) Adverse Events
    Ixabepilone Paclitaxel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 128/145 (88.3%) 117/144 (81.3%)
    Blood and lymphatic system disorders
    NEUTROPENIA 28/145 (19.3%) 15/144 (10.4%)
    Gastrointestinal disorders
    NAUSEA 27/145 (18.6%) 18/144 (12.5%)
    VOMITING 14/145 (9.7%) 5/144 (3.5%)
    DIARRHOEA 24/145 (16.6%) 19/144 (13.2%)
    STOMATITIS 6/145 (4.1%) 11/144 (7.6%)
    CONSTIPATION 9/145 (6.2%) 9/144 (6.3%)
    General disorders
    PAIN 10/145 (6.9%) 8/144 (5.6%)
    FATIGUE 27/145 (18.6%) 24/144 (16.7%)
    PYREXIA 6/145 (4.1%) 10/144 (6.9%)
    ASTHENIA 13/145 (9%) 10/144 (6.9%)
    MUCOSAL INFLAMMATION 9/145 (6.2%) 2/144 (1.4%)
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED 8/145 (5.5%) 12/144 (8.3%)
    ASPARTATE AMINOTRANSFERASE INCREASED 4/145 (2.8%) 9/144 (6.3%)
    Metabolism and nutrition disorders
    DECREASED APPETITE 12/145 (8.3%) 9/144 (6.3%)
    Musculoskeletal and connective tissue disorders
    MYALGIA 43/145 (29.7%) 18/144 (12.5%)
    BONE PAIN 30/145 (20.7%) 6/144 (4.2%)
    ARTHRALGIA 34/145 (23.4%) 15/144 (10.4%)
    PAIN IN EXTREMITY 8/145 (5.5%) 7/144 (4.9%)
    MUSCULOSKELETAL PAIN 16/145 (11%) 7/144 (4.9%)
    Nervous system disorders
    HEADACHE 6/145 (4.1%) 9/144 (6.3%)
    DYSGEUSIA 2/145 (1.4%) 8/144 (5.6%)
    PARAESTHESIA 10/145 (6.9%) 4/144 (2.8%)
    NEUROPATHY PERIPHERAL 24/145 (16.6%) 23/144 (16%)
    PERIPHERAL SENSORY NEUROPATHY 27/145 (18.6%) 44/144 (30.6%)
    Psychiatric disorders
    INSOMNIA 16/145 (11%) 17/144 (11.8%)
    Respiratory, thoracic and mediastinal disorders
    COUGH 7/145 (4.8%) 19/144 (13.2%)
    Skin and subcutaneous tissue disorders
    RASH 13/145 (9%) 16/144 (11.1%)
    ALOPECIA 4/145 (2.8%) 9/144 (6.3%)
    NAIL DISORDER 7/145 (4.8%) 12/144 (8.3%)
    Vascular disorders
    HOT FLUSH 8/145 (5.5%) 12/144 (8.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

    Results Point of Contact

    Name/Title BMS Study Director
    Organization Bristol-Myers Squibb
    Phone
    Email Clinical.Trials@bms.com
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00455533
    Other Study ID Numbers:
    • CA163-100
    • EUDRACT 2006-003047-24
    First Posted:
    Apr 3, 2007
    Last Update Posted:
    Feb 24, 2016
    Last Verified:
    Jan 1, 2016