Ixabepilone + Carboplatin Metastatic Breast Cancer

• Sponsor: US Oncology Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01075100
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 103
• Locations: 59
• Arm: 1
• Duration (Months): 41
• Patients Per Site: 1.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Ixabepilone adds significantly to the antitumor effectiveness of capecitabine in both ER+ and triple negative breast cancer. Ixabepilone has substantial antitumor activity in taxane-refractory patients and novel combinations are needed in this poor prognosis population. Carboplatin in combination with gemcitabine or paclitaxel has activity in metastatic breast cancer (MBC); there is also demonstrated activity of the gemcitabine/carboplatin combination in the ER+ versus triple negative subsets. A Phase I study of ixabepilone plus carboplatin in solid tumor patients demonstrated the safety of this combination at the doses and schedule proposed for this Phase II trial (BMS data on file).

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Drug: Ixabepilone; Drug: Carboplatin	Phase 2

Detailed Description

This is a Phase II, open label, nonrandomized, parallel, noncomparative, study of 2 groups (as stratified below). All patients will receive ixabepilone 20 mg/m2 on Days 1 and 8 and carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle. Patients will be stratified by either hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]- (n=50) or triples negative ER-/PR-/HER2- (n=53). If one group fulfills their accrual goal first, registration into that strata will be stopped and only patients meeting stratification requirements for the other group will be registered.

Study Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Ixabepilone Plus Carboplatin in Patients With Metastatic Breast Cancer: The ECLIPSE Study
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Weekly Ixabepilone +carboplatin Subjects will receive ixabepilone and carboplatin on Days 1 and 8 of each 21-day cycle.	Drug: Ixabepilone; 20 mg/m2 on Days 1 and 8; Other Names: Ixempra azaepothilone B ; Drug: Carboplatin; carboplatin AUC=2.5 on Days 1 and 8; Other Names: Paraplatin

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate (ORR) [24 months]

   Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]) and ER-/PR-HER2-, separately). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary Outcome Measures

1. Clinical Benefit Rate (CBR) [24 months]

   Clinical benefit rate (CBR) defined as objective response rate (ORR, CR + PR) + SD >= 6 months

2. Progression-free Survival (PFS) [24 months]

   PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

3. Overall Survival (OS) [24 months]

   OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

4. Time to Response [24 months]

   For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.

5. Duration of Response [30 months]

   The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

Male or female patients will be eligible for inclusion in this study if they meet all of the following criteria:

1. Has measurable metastatic and or locally unresectable breast cancer with documented HER2 negative (-) disease

2. Has at least 1 measurable lesion per RECIST criteria (lesions that can be accurately measured in at least 1 dimension (longest diameter (LD) to be recorded) as ≥20 mm with conventional techniques (CT, MRI, X-ray) or as ≥10 mm with spiral CT scan). Irradiated lesions cannot be used to assess response but can be used to assess progression.

3. Has received up to 2 (0 to 2) prior chemotherapy regimens for metastatic disease with the following conditions:

•Has had no prior treatment with ixabepilone or platinum agents

1. Has had no adjuvant chemotherapy within the 6 months prior to study, but may have received prior anthracyclines and/or taxanes as adjuvant chemotherapy

2. 3 weeks or more have elapsed since last chemotherapy treatment and any related toxicities have resolved to <Grade 1; at least 30 days must have passed since any investigational product has been administered and associated toxicities must have resolved to <Grade 1 (if applicable).

3. Has an ECOG Performance Status (PS) 0-2

4. Is ≥18 years of age

5. Has a life expectancy of at least 12 weeks

6. Has laboratory values of:

White blood cell (WBC) count ≥3000 x 106/L Absolute neutrophil count (ANC) ≥1500 x 106/L Hemoglobin ≥9 g/dL Total bilirubin ≤1x upper limit of normal (ULN) AST and ALT ≤2.5 x ULN Alkaline phosphatase ≤2.5 x ULN; up to 5xULN if elevation is due to bone disease Serum creatinine ≤1.5 mg/dL Calculated creatinine clearance >50 mL/min (based on Cockroft and Gault method [Appendix III]) Platelet count ≥100,000 x 106/L

1. If patient has had radiation therapy, it has been completed >3 weeks prior to the start of study treatment. NOTE: Previously irradiated lesions will not be evaluable. However, these patients will still be eligible.

2. Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential [not surgically sterilized and between menarche and 1 year postmenopause

3. If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 3 months thereafter

4. Has signed the most recent Patient Informed Consent Form

5. Has signed a Patient Authorization Form Note: Having tissue available is not an inclusion criterion in this study; however, available tissue will be collected (see Section 8) if possible.

Exclusion Criteria:

A patient will be excluded from this study if he or she meets any of the following criteria:

1. Had prior treatment with ixabepilone or other epothilones

2. Had prior radiation to ≥30% of major bone marrow containing areas (pelvis, lumbar spine)

3. Has ER+ and/or PR+ disease that has not progressed on hormone therapy, unless the patient has life-threatening or rapidly progressing visceral disease

4. Has HER2+ disease (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells]), a FISH result of more than 6 HER2 gene copies per nucleus or a FISH ratio (HER2 gene signals to chromosome 17 signals of >2.2)

5. Has only lytic bone disease or nonmeasurable disease only

6. Has a known, prior, severe (NCI CTCAE Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor®EL (polyoxyethylated castor oil) or has history of severe allergic reactions to cisplatin or other platinum-containing compounds

7. Has been treated previously with a platinum-containing agent

8. Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Washout periods for these prior therapies are specified in Section 5.

9. Is receiving concurrent investigational therapy or has received such therapy within the 30 days prior to dosing Day 1

10. Has neuropathy (motor or sensory) >Grade 1

11. Has evidence of CNS involvement requiring radiation or steroid treatment. Patients with stable brain metastases who are off steroids at least 2 weeks are eligible.

12. Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection

13. Has clinically relevant coagulopathy either secondary to hepatic dysfunction or an underlying condition requiring therapeutic anticoagulation (specifically, A-fib, history of DVT). A daily aspirin or Plavix for CAD are permitted.

14. Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs

15. Is a pregnant or breast feeding woman

16. Is unable to comply with the requirements of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematology Oncology Associates	Phoenix	Arizona	United States	85012
2	Arizona Oncology Associates, PC - NAHOA	Sedona	Arizona	United States	86336
3	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona	United States	85704
4	Southwest Cancer care	Murrieta	California	United States	92562
5	Rocky Mountain Cancer Centers	Denver	Colorado	United States	80220
6	Florida Cancer Institute - New Hope	Hudson	Florida	United States	34667
7	Melbourne Internal Medicine Associates	Melbourne	Florida	United States	32901
8	Florida Institute of Research, Medicine & Surgery	Ocoee	Florida	United States	34761
9	Cancer Care & Hematology Specialists of Chicagoland	Niles	Illinois	United States	60714
10	Central Indiana Cancer Centers	Carmel	Indiana	United States	46032
11	Alliance Hematology Oncology, P.A.	Westminster	Maryland	United States	21157
12	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota	United States	55404
13	Maryland Oncology Hematology, PA The Medical Pavillion at Howard County	Columbia	Missouri	United States	21044
14	Missouri Cancer Associates	Columbia	Missouri	United States	65201
15	Kansas City Cancer Center, LLC	Kansas City	Missouri	United States	64131
16	St. Joseph Oncology, Inc.	St. Joseph	Missouri	United States	64507
17	Comprehensive Cancer Care Centers of Nevada	Henderson	Nevada	United States	89074
18	Hematology-Oncology Associates of Northern NJ, PA Carol G. Simon Cancer Center	Morristown	New Jersey	United States	07962
19	Ruth Oratz MD	New York	New York	United States	10016
20	Interlakes Oncology & Hematology, P.C	Rochester	New York	United States	14623
21	Raleigh Hematology Oncology Associates	Raleigh	North Carolina	United States	27607
22	Dayton Oncology & Hematology, P.A. Greater Dayton Cancer Center	Kettering	Ohio	United States	45409
23	Northwest Cancer Specialists, PC	Portland	Oregon	United States	97213
24	Medical Oncology Associates of Wyoming Valley, PC	Kingston	Pennsylvania	United States	18704
25	Cancer Centers of the Carolinas	Greenville	South Carolina	United States	29605
26	Texas Oncology - Abilene	Abilene	Texas	United States	79606
27	Texas Oncology - Amarillo	Amarillo	Texas	United States	79106
28	Texas Oncology - Austin Midtown	Austin	Texas	United States	78705
29	Texas Oncology - Bedford	Bedford	Texas	United States	76022
30	Texas Oncology Medical City Dallas	Dallas	Texas	United States	75230
31	Texas Oncology-Dallas Presbyterian Hospital	Dallas	Texas	United States	75231
32	Texas Oncology-Methodist Charlton Cancer Center	Dallas	Texas	United States	75237
33	Texas Oncology	Dallas	Texas	United States	75246
34	Texas Oncology- Denton South	Denton	Texas	United States	76210
35	Texas Oncology-Fort Worth 12 Ave	Fort Worth	Texas	United States	76104
36	Texas Oncology-Memorial City	Houston	Texas	United States	77024
37	Texas Oncology- Lewisville	Lewisville	Texas	United States	75067
38	Texas Oncology-Longview Cancer Center	Longview	Texas	United States	75601
39	Texas Oncology-McAllen South Second Street	McAllen	Texas	United States	78509
40	Texas Oncology-Mesquite	Mesquite	Texas	United States	75150
41	Texas Oncology-Midland Allison Cancer Center	Midland	Texas	United States	79701
42	Texas Oncology- Odessa West Texas Cancer Center	Odessa	Texas	United States	79761
43	Paris Regional Cancer Center	Paris	Texas	United States	75460
44	Cancer Care Centers of South Texas	San Antonio	Texas	United States	78217
45	Cancer Care Centers of South Texas-HOAST	San Antonio	Texas	United States	78229
46	Texas Cancer Center - Sherman	Sherman	Texas	United States	75090
47	Texas Oncology - Sugar Land	Sugar Land	Texas	United States	77479
48	Texas Oncology-Tyler	Tyler	Texas	United States	75702
49	Texas Oncology-Waco	Waco	Texas	United States	76712
50	Texas Oncology Wichita Falls Texoma Cancer Center	Wichita Falls	Texas	United States	76310
51	Virginia Oncology Associates	Norfolk	Virginia	United States	23502
52	Highline Medical Oncology	Burien	Washington	United States	98166
53	Puget Sound Cancer Centers	Edmonds	Washington	United States	98026
54	Columbia Basin Hematology & Oncology	Kennewick	Washington	United States	99336
55	Puget Sound Cancer Centers	Seattle	Washington	United States	98133
56	Cancer Care Northwest	Spokane	Washington	United States	99202
57	Evergreen Hematology & Oncology	Spokane	Washington	United States	99218
58	Yakima Valley Memorial Hospital/North Star Lodge	Yakima	Washington	United States	98902
59	Raleigh Regional Cancer Center dba Beckley Oncology Associates Inc.	Beckley	West Virginia	United States	25801

Sponsors and Collaborators

• US Oncology Research
• Bristol-Myers Squibb

Investigators

• Principal Investigator: Cynthia R Osborne, MD, US Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Oncology Research
• ClinicalTrials.gov Identifier: NCT01075100
• Other Study ID Numbers: 08007
• First Posted: Feb 24, 2010
• Last Update Posted: Dec 7, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by US Oncology Research: metastatic; breast; cancer
• Additional relevant MeSH terms: Breast Neoplasms; Carboplatin

Study Results

Participant Flow

Arm/Group Title	Triple Negative	HR Positive
Arm/Group Description	ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.	ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
Period Title: Overall Study
STARTED	49	54
COMPLETED	0	1
NOT COMPLETED	49	53

Baseline Characteristics

Arm/Group Title	Triple Negative	HR Positive	Total
Arm/Group Description	ER-/PR-/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.	ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.	Total of all reporting groups
Overall Participants	49	54	103
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.0 (9.0)	56.7 (10.6)	55.9 (9.9)
Sex: Female, Male (Count of Participants)
Female	49 100%	54 100%	103 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	33 67.3%	39 72.2%	72 69.9%
Hispanic	2 4.1%	2 3.7%	4 3.9%
Hawaiian	0 0%	1 1.9%	1 1%
Black	14 28.6%	10 18.5%	24 23.3%
Asian	0 0%	2 3.7%	2 1.9%
Region of Enrollment (participants) [Number]
United States	49 100%	54 100%	103 100%

Outcome Measures

1. Primary Outcome

Title	Objective Response Rate (ORR)
Description	Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]) and ER-/PR-HER2-, separately). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Evaluable population

Arm/Group Title	Triple Negative	HR Positive
Arm/Group Description	ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.	ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
Measure Participants	46	53
Number (95% Confidence Interval) [percentage of participants]	30.4 62%	34 63%

2. Secondary Outcome

Title	Clinical Benefit Rate (CBR)
Description	Clinical benefit rate (CBR) defined as objective response rate (ORR, CR + PR) + SD >= 6 months
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Evaluable population

Arm/Group Title	Triple Negative	HR Positive
Arm/Group Description	ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.	ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
Measure Participants	46	53
Number (95% Confidence Interval) [percentage of participants]	41.3 84.3%	56.6 104.8%

3. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Triple Negative	HR Positive
Arm/Group Description	ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.	ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
Measure Participants	49	54
Median (95% Confidence Interval) [months]	7.6	7.6

4. Secondary Outcome

Title	Overall Survival (OS)
Description	OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Triple Negative	HR Positive
Arm/Group Description	ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.	ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
Measure Participants	49	54
Median (95% Confidence Interval) [months]	12.5	17.9

5. Secondary Outcome

Title	Time to Response
Description	For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Patients who achieve a major objective response (CR or PR).

Arm/Group Title	Triple Negative	HR Positive
Arm/Group Description	ER-/PR-/HER2- patients who receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.	ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
Measure Participants	14	18
Median (Full Range) [months]	1.27	1.60

6. Secondary Outcome

Title	Duration of Response
Description	The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.
Time Frame	30 months

Outcome Measure Data

Analysis Population Description

Patients who achieved CR or PR.

Arm/Group Title	Triple Negative	HR Positive
Arm/Group Description	ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.	ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
Measure Participants	14	18
Median (Full Range) [months]	6.68	5.92

Adverse Events

Time Frame	During the whole treatment period, up to 30 days following last dose.
Adverse Event Reporting Description	For treated patients only, assessed at each treatment visit.
Arm/Group Title	Triple Negative		HR Positive
Arm/Group Description	ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.		ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
All Cause Mortality
	Triple Negative		HR Positive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Triple Negative		HR Positive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/48 (20.8%)		5/53 (9.4%)
Blood and lymphatic system disorders
NEUTROPENIA	1/48 (2.1%)	1	1/53 (1.9%)	1
THROMBOCYTOPENIA	0/48 (0%)	0	1/53 (1.9%)	1
VOLUME BLOOD DECREASED	1/48 (2.1%)	1	0/53 (0%)	0
Cardiac disorders
FIBRILLATION ATRIAL	1/48 (2.1%)	1	0/53 (0%)	0
HYPOTENSION	1/48 (2.1%)	2	0/53 (0%)	0
Gastrointestinal disorders
ABDOMINAL PAIN	1/48 (2.1%)	1	0/53 (0%)	0
APPETITE DECREASED	0/48 (0%)	0	1/53 (1.9%)	1
DEHYDRATION	4/48 (8.3%)	4	0/53 (0%)	0
DIARRHEA	4/48 (8.3%)	4	0/53 (0%)	0
NAUSEA	3/48 (6.3%)	3	1/53 (1.9%)	1
VOMITING	2/48 (4.2%)	2	1/53 (1.9%)	1
General disorders
FEVER	1/48 (2.1%)	1	1/53 (1.9%)	1
RIGORS	0/48 (0%)	0	1/53 (1.9%)	1
WEAKNESS GENERALIZED	1/48 (2.1%)	1	0/53 (0%)	0
Infections and infestations
BACTERIAL RESISTANCE	0/48 (0%)	0	1/53 (1.9%)	1
SEPSIS	1/48 (2.1%)	1	1/53 (1.9%)	1
Metabolism and nutrition disorders
HYPOKALEMIA	1/48 (2.1%)	1	0/53 (0%)	0
HYPONATREMIA	1/48 (2.1%)	1	0/53 (0%)	0
Nervous system disorders
DIZZINESS	1/48 (2.1%)	1	0/53 (0%)	0
Renal and urinary disorders
RENAL INSUFFICIENCY	1/48 (2.1%)	1	0/53 (0%)	0
Respiratory, thoracic and mediastinal disorders
EMBOLISM PULMONARY	0/48 (0%)	0	1/53 (1.9%)	1
PNEUMONIA	0/48 (0%)	0	1/53 (1.9%)	1
RESPIRATION RATE DECREASED	0/48 (0%)	0	1/53 (1.9%)	1
SHORTNESS OF BREATH	1/48 (2.1%)	1	0/53 (0%)	0
Other (Not Including Serious) Adverse Events
	Triple Negative		HR Positive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	44/48 (91.7%)		52/53 (98.1%)
Blood and lymphatic system disorders
ANEMIA	27/48 (56.3%)	58	28/53 (52.8%)	103
EDEMA	1/48 (2.1%)	1	3/53 (5.7%)	3
LEUCOPENIA	6/48 (12.5%)	13	14/53 (26.4%)	58
NEUTROPENIA	31/48 (64.6%)	99	39/53 (73.6%)	184
THROMBOCYTOPENIA	16/48 (33.3%)	44	25/53 (47.2%)	65
Gastrointestinal disorders
ABDOMINAL PAIN	6/48 (12.5%)	6	5/53 (9.4%)	6
ANOREXIA	6/48 (12.5%)	8	13/53 (24.5%)	18
CONSTIPATION	6/48 (12.5%)	6	13/53 (24.5%)	17
DEHYDRATION	1/48 (2.1%)	1	7/53 (13.2%)	12
DIARRHEA	13/48 (27.1%)	18	15/53 (28.3%)	22
DYSGUESIA	6/48 (12.5%)	6	8/53 (15.1%)	12
DYSPEPSIA	1/48 (2.1%)	1	3/53 (5.7%)	3
GASTROESOPHAGEAL REFLUX	2/48 (4.2%)	2	3/53 (5.7%)	3
NAUSEA	23/48 (47.9%)	40	31/53 (58.5%)	47
VOMITING	8/48 (16.7%)	12	19/53 (35.8%)	26
General disorders
CHILLS	3/48 (6.3%)	3	0/53 (0%)	0
FATIGUE	18/48 (37.5%)	29	31/53 (58.5%)	58
FEVER	3/48 (6.3%)	3	3/53 (5.7%)	3
PAIN	2/48 (4.2%)	2	5/53 (9.4%)	6
WEAKNESS	4/48 (8.3%)	6	2/53 (3.8%)	2
WEIGHT LOSS	3/48 (6.3%)	3	3/53 (5.7%)	3
Immune system disorders
ALLERGIC REACTION	3/48 (6.3%)	3	5/53 (9.4%)	6
Infections and infestations
MUCOSITIS	1/48 (2.1%)	1	3/53 (5.7%)	4
Metabolism and nutrition disorders
HYPOKALEMIA	3/48 (6.3%)	4	3/53 (5.7%)	4
HYPOMAGNESAEMIA	3/48 (6.3%)	3	1/53 (1.9%)	2
Musculoskeletal and connective tissue disorders
ARTHRALGIA	0/48 (0%)	0	4/53 (7.5%)	6
MUSCLE WEAKNESS	3/48 (6.3%)	8	1/53 (1.9%)	1
MYALGIA	2/48 (4.2%)	3	5/53 (9.4%)	5
PAIN BACK	0/48 (0%)	0	3/53 (5.7%)	3
Nervous system disorders
DIZZINESS	2/48 (4.2%)	2	4/53 (7.5%)	4
NEUROPATHY	22/48 (45.8%)	35	27/53 (50.9%)	51
Skin and subcutaneous tissue disorders
ALOPECIA	15/48 (31.3%)	16	20/53 (37.7%)	22
NAIL DISORDER	3/48 (6.3%)	4	6/53 (11.3%)	7
RASH	0/48 (0%)	0	5/53 (9.4%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.