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Genistein in Preventing Breast Cancer in Women at High Risk for Breast Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00290758
Collaborator
(none)
126
Enrollment
1
Location
2
Arms
42
Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized phase II trial is studying how well genistein works in preventing breast cancer in women at high risk for breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of genistein may prevent breast cancer in women at high risk for breast cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PRIMARY OBJECTIVE:
  1. Determine the effect of genistein on the proliferation of breast epithelial cells obtained by fine needle aspiration (FNA), as measured by Ki-67 labeling index, in women who are at high risk for breast cancer.
SECONDARY OBJECTIVE:
  1. Determine the effect of this drug on cellular and molecular parameters using epithelial cells obtained by FNA, nipple aspirate fluid, and blood from these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to menopausal status (premenopausal vs postmenopausal) and history of breast cancer (no history of breast cancer vs history of estrogen receptor [ER] positive breast cancer vs history of ER negative breast cancer). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral genistein once daily.

ARM II: Patients receive oral placebo once daily.

In both arms, treatment continues for up to 6 months in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed at 30-37 days.

Study Design

Study Type:
Interventional
Actual Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Phase IIB Trial of G-2535 (Unconjugated Isoflavones-100) in Women at High Risk for Breast Cancer
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (genistein)

Patients receive oral genistein once daily for up to 6 months.

Drug: genistein
Given orally
Other Names:
  • CI 75610
  • genisteol
  • genisterin
  • prunetol
  • sophoricol

    • Other: laboratory biomarker analysis
    Correlative studies
    Placebo Comparator: Arm II (placebo)

    Patients receive oral placebo once daily for up to 6 months.

    Drug: placebo
    Given orally
    Other Names:
  • PLCB

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling [6 months - baseline]

      Breast epithelial tissue samples are used to measure the expression of the cell proliferation marker Ki-67, by counting the percentage of positive MIB-1 immunostained cells, denoted the Ki-67 labeling index. Mean change in the Ki-67 labeling index is assessed from baseline to 6 month follow up.

    Secondary Outcome Measures

    1. Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF) [6 months - baseline]

      Mean change in the concentration of EGF found in nipple aspirate fluid is assessed from baseline to 6 month follow up.

    2. Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells. [6 months - baseline]

      Cytologic atypia evaluation was performed on Papanicolau stained Thin Prep slides using standard criteria, which were also used for spectral spatial imaging. Cell clusters were used to generate image stacks with the Nuance LCTF-based imaging system (CRI Inc). The image data was collected as percent pixels assigned as "atypical". Mean change in the percent pixels assigned "atypical" is assessed from baseline to 6 month follow up.

    3. Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Estradiol [6 months - baseline]

      Mean change in concentration of estradiol measured in nipple aspiration fluid assessed from baseline to 6 month follow up.

    4. Monitor Drug Delivery by Measuring Plasma Genistein by HPLC [6 months - baseline]

      Drug delivery is measured be concentration of genistein in plasma using High Performance Liquid Chromatography (HPLC). Mean change in concentration of plasma genistein is assessed from baseline to 6 month follow up.

    5. Plasma Concentration of Sex Hormone Binding Globulin (SHBG) [6 months - baseline]

    6. Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D [6 months - baseline]

      Mean change in concentration of Cathepsin D measured in nipple aspiration fluid assessed from baseline to 6 month follow up.

    7. Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2 [6 month - baseline]

      Mean change in concentration of protein ps2 measured in nipple aspiration fluid assessed from baseline to 6 month follow up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • No known soy intolerance

    • At increased risk of developing breast cancer in >= 1 previously unaffected breast, as defined by any of the following:

    • Estimated 5-year risk of developing breast cancer using the Gail model, as defined by 1 of the following:

    • Gail score >= 1.66%

    • Gail score >= 0.1% for women age 20-29 years

    • Gail score >= 1.0% for women age 30-39 years

    • Estimated 5-year risk of developing breast cancer using the Claus model:

    • Claus score >= 1.66%

    • Claus score >= 0.1% for women age 20-29 years

    • Claus score >= 1.0% for women age 30-39 years

    • Prior diagnosis of unilateral in situ or invasive breast cancer OR history of atypical hyperplasia, BRCA 1 and/or BRCA 2 positivity

    • History of lobular carcinoma in situ

    • No evidence of breast cancer, as determined by a negative mammogram within the past 6 months and a history and physical

    • No previously diagnosed breast cancer unless all systemic therapy (including endocrine therapy) was completed at least 1 year ago

    • Pre- or postmenopausal

    • ECOG performance status 0-1

    • Hemoglobin > 10.0 g/dL

    • Platelet count > 100,000/mm^3

    • Absolute neutrophil count > 1,000/mm^3

    • Creatinine < 2.0 mg/dL

    • SGPT < 82 U/L

    • SGOT < 68 U/L

    • Bilirubin < 3 mg/dL* [Note: * Patients with a higher level of bilirubin due to a familial metabolism may be eligible at the discretion of the investigator]

    • Life expectancy > 2 years

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective barrier contraception

    • Must be willing to keep a dietary diary

    • No venous thrombosis within the past year

    • No unrecognized or poorly controlled thyroid disease

    • No other cancer within the past 5 years except nonmelanomatous skin cancer or noninvasive cervical cancer

    • No other medical condition that, in the opinion of the investigator, would jeopardize either the patient or the integrity of the data obtained

    • None of the following for >= 2 weeks before the first random fine needle aspiration and during study participation:

    • Oral contraceptives

    • Soy supplements

    • High soy-containing foods

    • Fish oil supplements

    • Multivitamins

    • Vitamins C and E

    • Daily aspirin or nonsteroidal

    • Anti-inflammatory drugs

    • No other concurrent investigational agents

    • No concurrent warfarin or other blood thinners

    • Female patient

    Exclusion Criteria:

    Women previously diagnosed with breast cancer will not be eligible unless all systemic therapy (including endocrine therapy) was completed at least one year previously

    • Currently pregnant, or planning to become pregnant during the study period

    • History of venous thrombosis within past year

    • Medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained

    • History of other cancer within the past five years, excluding non-melanomatous skin cancer, and non-invasive cervical cancer

    • Known soy intolerance

    • Unrecognized or uncontrolled thyroid disease, subjects may be on synthroid, but thyroid function must be in normal range or the patient's physician must document that the patient's thyroid is controlled.

    • Currently receiving any other investigational agents

    • Currently on coumadin, or other blood thinners

    • History of breast augmentation implants.

    • Rusults from patients who have <4000 epithelial cells in either the first or the second random Fine-needle aspiration (rFNA) will not be included in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Chicago Illinois United States 60611

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Seema Khan, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00290758
    Other Study ID Numbers:
    • NCI-2009-00840
    • NCI-2009-00840
    • CDR0000652922
    • NCI-04B3
    • NWU03-1-04
    • N01CN35157
    First Posted:
    Feb 13, 2006
    Last Update Posted:
    Feb 8, 2017
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Genistein

    Study Results

    Participant Flow

    Recruitment Details Study opened to accrual January 6, 2006. Study closed to accrual August 27, 2008. Subjects were recruited from the Lynn Sage Comprehensive Breast Center of Northwestern University, through ads on public transportation, through website and flyer distributions.
    Pre-assignment Detail Potential subjects underwent a 2 week washout period of soy products, vitamins, and daily aspirin prior to a screening random fine need aspiration (rFNA) of the breast(s). Subjects for which 4,000 or more epithelial cells were obtained the first or second rFNA were considered eligible for study participation.
    Arm/Group Title Arm A (Genistein) Arm B (Placebo)
    Arm/Group Description Patients received oral genistein once daily for 6 months Patients received oral placebo once daily for 6 months
    Period Title: Pre-Intervention rFNA Through Follow-Up
    STARTED 62 64
    First rFNA Tissue Collection 62 64
    Randomization 62 62
    Treatment 61 64
    Post Intervention Follow-Up 55 54
    COMPLETED 55 54
    NOT COMPLETED 7 10
    Period Title: Pre-Intervention rFNA Through Follow-Up
    STARTED 55 54
    COMPLETED 49 49
    NOT COMPLETED 6 5

    Baseline Characteristics

    Arm/Group Title Arm A Arm B Total
    Arm/Group Description Patients receive oral genistein once daily for up to 6 months. Patients receive oral placebo once daily for up to 6 months. Total of all reporting groups
    Overall Participants 62 64 126
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    61
    98.4%
    63
    98.4%
    124
    98.4%
    >=65 years
    1
    1.6%
    1
    1.6%
    2
    1.6%
    Gender (Count of Participants)
    Female
    62
    100%
    64
    100%
    126
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    3.2%
    2
    3.1%
    4
    3.2%
    Not Hispanic or Latino
    60
    96.8%
    62
    96.9%
    122
    96.8%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    1
    1.6%
    0
    0%
    1
    0.8%
    Black or African American
    7
    11.3%
    12
    18.8%
    19
    15.1%
    White
    54
    87.1%
    52
    81.3%
    106
    84.1%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling
    Description Breast epithelial tissue samples are used to measure the expression of the cell proliferation marker Ki-67, by counting the percentage of positive MIB-1 immunostained cells, denoted the Ki-67 labeling index. Mean change in the Ki-67 labeling index is assessed from baseline to 6 month follow up.
    Time Frame 6 months - baseline

    Outcome Measure Data

    Analysis Population Description
    Participants who had more than 4,000 epithelial cells in rFNA samples at both baseline and 6 month follow up, met the criteria for compliance, and were available for evaluation of Ki-67 labeling index at both time points. Analysis performed by menopause and cancer status.
    Arm/Group Title Arm A (Genistein) Arm B (Placebo)
    Arm/Group Description Patients receive oral genistein once daily for up to 6 months. Patients receive oral placebo once daily for up to 6 months.
    Measure Participants 49 49
    Postmenopausal with ER- Cancer
    .325
    (.343)
    .289
    (.541)
    Postmenopausal with ER+ Cancer
    -.418
    (.191)
    -.461
    (.458)
    Postmenopausal Without Cancer
    -.092
    (.525)
    -.122
    (.735)
    Premonopausal with ER- Cancer
    -.335
    (.930)
    .873
    (.786)
    Premenopausal with ER+ Cancer
    -.387
    (.806)
    -.204
    (1.329)
    Premenopausal without cancer
    1.171
    (2.922)
    0.557
    (1.546)
    2. Secondary Outcome
    Title Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF)
    Description Mean change in the concentration of EGF found in nipple aspirate fluid is assessed from baseline to 6 month follow up.
    Time Frame 6 months - baseline

    Outcome Measure Data

    Analysis Population Description
    NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in EGF concentration available for 43 participants. Analysis performed by menopause and cancer status.
    Arm/Group Title Arm A (Genistein) Arm B (Placebo)
    Arm/Group Description Patients received oral genistein once daily for 6 months Patients received oral placebo once daily for 6 months
    Measure Participants 23 20
    Postmenopausal with ER- Cancer
    -133.07
    (308.28)
    Postmenopausal with ER+ Cancer
    -197.8
    (16.01)
    Postmenopausal without cancer
    201.05
    (380.72)
    -38.74
    (226.18)
    Premenopausal with ER- Cancer
    -93.23
    (0)
    37.38
    (69.11)
    Premenopausal with ER+ Cancer
    20.63
    (0)
    Premenopausal without cancer
    -9.16
    (296.55)
    -9.26
    (175.57)
    3. Secondary Outcome
    Title Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells.
    Description Cytologic atypia evaluation was performed on Papanicolau stained Thin Prep slides using standard criteria, which were also used for spectral spatial imaging. Cell clusters were used to generate image stacks with the Nuance LCTF-based imaging system (CRI Inc). The image data was collected as percent pixels assigned as "atypical". Mean change in the percent pixels assigned "atypical" is assessed from baseline to 6 month follow up.
    Time Frame 6 months - baseline

    Outcome Measure Data

    Analysis Population Description
    Analysis performed by menopause and cancer status.
    Arm/Group Title Arm A (Genistein) Arm B (Placebo)
    Arm/Group Description Patients receive oral genistein once daily for up to 6 months. Patients receive oral placebo once daily for up to 6 months.
    Measure Participants 49 49
    Postmenopausal with ER- Cancer
    -1.25
    (0.96)
    0
    (0)
    Postmenopausal with ER+ Cancer
    -3.00
    (2.12)
    -.40
    (0.89)
    Postmenopausal Without Cancer
    -0.50
    (1.87)
    0
    (1.45)
    Premenopausal with ER- Cancer
    0.50
    (0.71)
    0
    (0)
    Premenopausal with ER+ Cancer
    0.50
    (1.29)
    -0.75
    (0.96)
    Premenopausal without cancer
    0.17
    (2.42)
    0.95
    (2.18)
    4. Secondary Outcome
    Title Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Estradiol
    Description Mean change in concentration of estradiol measured in nipple aspiration fluid assessed from baseline to 6 month follow up.
    Time Frame 6 months - baseline

    Outcome Measure Data

    Analysis Population Description
    NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in estradiol concentration available for 40 participants. Analysis performed by menopause and cancer status.
    Arm/Group Title Arm I (Genistein) Arm II (Placebo)
    Arm/Group Description Patients receive oral genistein once daily for up to 6 months. Patients receive oral placebo once daily for up to 6 months.
    Measure Participants 21 19
    Postmenopausal with ER- Cancer
    2251.92
    (292.66)
    Postmenopausal with ER+ Cancer
    -497.3
    (0)
    Postmenopausal Without Cancer
    -354.39
    (643.44)
    925.83
    (955.71)
    Premenopausal with ER- Cancer
    -129.58
    (0)
    -36.38
    (16.42)
    Premenopausal without cancer
    -591.81
    (992.24)
    6.31
    (394.74)
    5. Secondary Outcome
    Title Monitor Drug Delivery by Measuring Plasma Genistein by HPLC
    Description Drug delivery is measured be concentration of genistein in plasma using High Performance Liquid Chromatography (HPLC). Mean change in concentration of plasma genistein is assessed from baseline to 6 month follow up.
    Time Frame 6 months - baseline

    Outcome Measure Data

    Analysis Population Description
    Analysis performed by menopause and cancer status.
    Arm/Group Title Arm A (Genistein) Arm B (Placebo)
    Arm/Group Description Patients received oral genistein once daily for 6 months Patients received oral placebo once daily for 6 months
    Measure Participants 49 49
    Postmenopausal with ER- Cancer
    368.62
    (389.24)
    0
    (0)
    Postmenopausal with ER+ Cancer
    65.20
    (92.20)
    0
    (0)
    Postmenopausal Without Cancer
    190.42
    (226.17)
    0.65
    (2.52)
    Premenopausal with ER- Cancer
    472.09
    (350.16)
    4.56
    (6.44)
    Premenopausal with ER+ Cancer
    423.12
    (359.00)
    3.80
    (4.40)
    Premenopausal without cancer
    269.88
    (250.43)
    3.57
    (14.99)
    6. Secondary Outcome
    Title Plasma Concentration of Sex Hormone Binding Globulin (SHBG)
    Description
    Time Frame 6 months - baseline

    Outcome Measure Data

    Analysis Population Description
    Plasma concentration of SHBG was not available for 1 patient in Arm A. Analysis performed by menopause and cancer status.
    Arm/Group Title Arm A (Genistein) Arm B (Placebo)
    Arm/Group Description Patients receive oral genistein once daily for up to 6 months. Patients receive oral placebo once daily for up to 6 months.
    Measure Participants 48 49
    Postmenopausal with ER- Cancer
    7.39
    (28.64)
    22.07
    (50.65)
    Postmenopausal with ER+ Cancer
    -17.84
    (0.55)
    -8.12
    (13.40)
    Postmenopausal Without Cancer
    3.94
    (26.42)
    -20.49
    (50.03)
    Premenopausal with ER- Cancer
    15.61
    (14.79)
    -27.34
    (12.13)
    Premenopausal with ER+ Cancer
    1.99
    (15.26)
    -14.79
    (17.41)
    Premenopausal without cancer
    -11.18
    (39.90)
    3.79
    (29.96)
    7. Secondary Outcome
    Title Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D
    Description Mean change in concentration of Cathepsin D measured in nipple aspiration fluid assessed from baseline to 6 month follow up.
    Time Frame 6 months - baseline

    Outcome Measure Data

    Analysis Population Description
    NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in Cathespin D concentration available for 44 participants. Analysis performed by menopause and cancer status.
    Arm/Group Title Arm I (Genistein) Arm II (Placebo)
    Arm/Group Description Patients receive oral genistein once daily for up to 6 months. Patients receive oral placebo once daily for up to 6 months.
    Measure Participants 23 21
    post menopausal with ER- cancer
    -3105.29
    (6764.20)
    post menopasual with ER+ caner
    -3961.16
    (1295.29)
    post menopausal without cancer
    3362.326
    (9545.02)
    -1774.72
    (17644.27)
    pre menopausal with ER- cancer
    1800.40
    (0)
    29337.79
    (36645.39)
    pre menopausal with ER+ cancer
    -6218.25
    (0)
    Pre menopausal without Cancer
    -4904.09
    (28128.12)
    486.56
    (40420.50)
    8. Secondary Outcome
    Title Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2
    Description Mean change in concentration of protein ps2 measured in nipple aspiration fluid assessed from baseline to 6 month follow up.
    Time Frame 6 month - baseline

    Outcome Measure Data

    Analysis Population Description
    NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in ps2 concentration available for 44 participants. Analysis performed by menopause and cancer status.
    Arm/Group Title Arm I (Genistein) Arm II (Placebo)
    Arm/Group Description Patients receive oral genistein once daily for up to 6 months. Patients receive oral placebo once daily for up to 6 months.
    Measure Participants 23 21
    Post menopausal with ER- cancer
    -28.00
    (41.85)
    Post menopasual with ER+ caner
    -61.06
    (10.06)
    Post menopausal without cancer
    -14.17
    (32.40)
    -6.10
    (65.38)
    Pre menopausal with ER- cancer
    -16.68
    (0)
    4.69
    (23.75)
    Pre menopausal with ER+ cancer
    -31.46
    (0)
    Pre menopausal without Cancer
    -20.49
    (54.30)
    12.17
    (29.74)

    Adverse Events

    Time Frame 3 years
    Adverse Event Reporting Description February, 2006 th March, 2009
    Arm/Group Title Arm A (Genistein) Arm B (Placebo)
    Arm/Group Description Patients take oral genistein once daily for up to 6 months. Patients take oral placebo once daily for up to 6 months.
    All Cause Mortality
    Arm A (Genistein) Arm B (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Arm A (Genistein) Arm B (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/62 (9.7%) 1/64 (1.6%)
    Musculoskeletal and connective tissue disorders
    Musculoskeletal 1/62 (1.6%) 1 0/64 (0%) 0
    Nervous system disorders
    Mood Alteration: Depression 1/62 (1.6%) 1 0/64 (0%) 0
    Renal and urinary disorders
    renal - Other 1/62 (1.6%) 1 0/64 (0%) 0
    Obstruction, GU: Uterus 1/62 (1.6%) 1 0/64 (0%) 0
    Reproductive system and breast disorders
    Sexual 0/62 (0%) 0 1/64 (1.6%) 1
    Respiratory, thoracic and mediastinal disorders
    Pulmonary/Upper Respiratory: Dyspnea 1/62 (1.6%) 1 0/64 (0%) 0
    Skin and subcutaneous tissue disorders
    Ulceration 1/62 (1.6%) 1 0/64 (0%) 0
    Other (Not Including Serious) Adverse Events
    Arm A (Genistein) Arm B (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 50/62 (80.6%) 56/64 (87.5%)
    Blood and lymphatic system disorders
    Hemorrhage - Other 1/62 (1.6%) 1 0/64 (0%) 0
    Hemorrhage with Surgery 1/62 (1.6%) 1 0/64 (0%) 0
    Hematoma 1/62 (1.6%) 1 1/64 (1.6%) 1
    Blood/bone marrow: Blood- Other 1/62 (1.6%) 1 1/64 (1.6%) 1
    Hemoglobin 1/62 (1.6%) 1 0/64 (0%) 0
    Leukocytes 1/62 (1.6%) 1 0/64 (0%) 0
    Edima: Limb 2/62 (3.2%) 2 1/64 (1.6%) 1
    Coagulation - Other 1/62 (1.6%) 1 0/64 (0%) 0
    Cardiac disorders
    Hypotension 1/62 (1.6%) 1 0/64 (0%) 0
    Supraventricular Arrythmia - Select Sinus Bradycardia 1/62 (1.6%) 1 0/64 (0%) 0
    Cardia Ischemia/Infarction 1/62 (1.6%) 1 1/64 (1.6%) 1
    Hypertension 2/62 (3.2%) 2 1/64 (1.6%) 1
    Palpitations 1/62 (1.6%) 1 1/64 (1.6%) 1
    Ear and labyrinth disorders
    Auditory/Ear - Other 1/62 (1.6%) 1 0/64 (0%) 0
    Endocrine disorders
    Hot Flashes 10/62 (16.1%) 11 8/64 (12.5%) 10
    Hypothyroidism 3/62 (4.8%) 3 1/64 (1.6%) 1
    Hyperthyroidism 0/62 (0%) 0 1/64 (1.6%) 1
    Endocrine - Other 1/62 (1.6%) 2 0/64 (0%) 0
    Eye disorders
    Blurred Vision 1/62 (1.6%) 1 1/64 (1.6%) 1
    Other 1/62 (1.6%) 1 0/64 (0%) 0
    Ocular - Other 0/62 (0%) 0 2/64 (3.1%) 4
    Flashing Lights 0/62 (0%) 0 1/64 (1.6%) 1
    Gastrointestinal disorders
    Vomiting 5/62 (8.1%) 5 5/64 (7.8%) 6
    Diarrhea 6/62 (9.7%) 6 5/64 (7.8%) 6
    nausea 5/62 (8.1%) 5 2/64 (3.1%) 2
    Heartburn 2/62 (3.2%) 2 3/64 (4.7%) 3
    Constipation 2/62 (3.2%) 2 1/64 (1.6%) 1
    GI - Other 0/62 (0%) 0 1/64 (1.6%) 1
    Gastritis 0/62 (0%) 0 1/64 (1.6%) 1
    Flatulence 1/62 (1.6%) 1 1/64 (1.6%) 1
    General disorders
    Pain - Other 2/62 (3.2%) 2 0/64 (0%) 0
    Pain - Select: Throat/Pharynx/Larynx 3/62 (4.8%) 3 4/64 (6.3%) 5
    Pain - Select: Larynx 0/62 (0%) 0 1/64 (1.6%) 1
    Pain - Select: Back 4/62 (6.5%) 7 3/64 (4.7%) 5
    Pain - Select: Joint 3/62 (4.8%) 6 6/64 (9.4%) 7
    Pain - Select: Breast 4/62 (6.5%) 5 5/64 (7.8%) 5
    Pain - Select: Extremity - Limb 1/62 (1.6%) 2 4/64 (6.3%) 5
    Pain - Select: Head/Headaches 6/62 (9.7%) 9 6/64 (9.4%) 6
    Pain - Select: Cardiac/Heart 0/62 (0%) 0 1/64 (1.6%) 1
    Pain - Select: Abdomen Nos 2/62 (3.2%) 2 0/64 (0%) 0
    Pain - Select: Neuralgia 0/62 (0%) 0 1/64 (1.6%) 1
    Pain - Select: Eye 0/62 (0%) 0 1/64 (1.6%) 1
    Pain - Select: Bone 0/62 (0%) 0 1/64 (1.6%) 2
    Pain - Select: Skin 2/62 (3.2%) 4 0/64 (0%) 0
    Pain - Select: Uterus 2/62 (3.2%) 2 0/64 (0%) 0
    Pain - Select: Dental/Teeth/Peridontal 0/62 (0%) 0 1/64 (1.6%) 1
    Constitutional Symptoms - Other 3/62 (4.8%) 3 4/64 (6.3%) 5
    Constitutional Symptoms - Weight Gain 2/62 (3.2%) 2 0/64 (0%) 0
    Constitutional Symptoms - Fever 10/62 (16.1%) 10 2/64 (3.1%) 2
    Constitutional Symptoms - Fatigue 1/62 (1.6%) 1 3/64 (4.7%) 4
    Constitutional Symptoms - Insomnia 3/62 (4.8%) 3 2/64 (3.1%) 2
    Constitutional Symptoms - Rigors/Chills 1/62 (1.6%) 1 0/64 (0%) 0
    Constitutional Symptoms - Sweating 0/62 (0%) 0 1/64 (1.6%) 1
    Immune system disorders
    Allergic Reastion 0/62 (0%) 0 1/64 (1.6%) 6
    Infections and infestations
    Infection (documented clinically) Select: Bladder (Urinary) 0/62 (0%) 0 1/64 (1.6%) 1
    Infection with Unknown ANC - Select: Bronchus 2/62 (3.2%) 2 1/64 (1.6%) 1
    Infections - Other 3/62 (4.8%) 3 5/64 (7.8%) 5
    Infection with Unknwn ANC - Select: Vagina 3/62 (4.8%) 3 2/64 (3.1%) 4
    Infection with Unknown ANC - Select: Skin (Cellulitis) 1/62 (1.6%) 1 0/64 (0%) 0
    Infection (Documented ClinicallY) - Select: Vagina 1/62 (1.6%) 1 0/64 (0%) 0
    Infection With Unknown ANC - Select: Upper Airways Nose 0/62 (0%) 0 1/64 (1.6%) 2
    Infection With Unknown ANC - Select: Sinus 0/62 (0%) 0 1/64 (1.6%) 1
    Infection With Unknown ANC - Select: Urinary Tract Nos 0/62 (0%) 0 2/64 (3.1%) 2
    Infection (Documented Clinically) - Select: Sinus 0/62 (0%) 0 1/64 (1.6%) 1
    Infection With Unknown ANC - Select: Conjunctiva 0/62 (0%) 0 1/64 (1.6%) 1
    Infection (Documented Clinically) - Select: Urinary Tract Nos 0/62 (0%) 0 1/64 (1.6%) 1
    Infection (Documented Clinically) - Select: Pleura (Empyema) 0/62 (0%) 0 1/64 (1.6%) 1
    Metabolism and nutrition disorders
    Hypokalemia 1/62 (1.6%) 1 0/64 (0%) 0
    ALt 2/62 (3.2%) 2 0/64 (0%) 0
    AST 1/62 (1.6%) 1 0/64 (0%) 0
    Cholesterol 1/62 (1.6%) 1 0/64 (0%) 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal - Other (Specify) 8/62 (12.9%) 10 5/64 (7.8%) 7
    Joint - Function 0/62 (0%) 0 1/64 (1.6%) 1
    Nervous system disorders
    Mood Alteration - Select: Anxiety 4/62 (6.5%) 4 2/64 (3.1%) 2
    Mood Alteration - Select: Depression 2/62 (3.2%) 2 1/64 (1.6%) 1
    Dizziness 2/62 (3.2%) 2 1/64 (1.6%) 1
    Neurology (Other) 1/62 (1.6%) 1 0/64 (0%) 0
    Tremor 0/62 (0%) 0 1/64 (1.6%) 1
    Renal and urinary disorders
    Incontinence, Urinary 1/62 (1.6%) 1 0/64 (0%) 0
    Obstruction, GU - Select:: Uterus 1/62 (1.6%) 1 0/64 (0%) 0
    Cystitis 2/62 (3.2%) 2 1/64 (1.6%) 1
    Renal - Other 2/62 (3.2%) 2 1/64 (1.6%) 1
    Urinary Frequesncy 1/62 (1.6%) 1 0/64 (0%) 0
    Reproductive system and breast disorders
    Sexual - Other 6/62 (9.7%) 6 8/64 (12.5%) 12
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 1/62 (1.6%) 1 0/64 (0%) 0
    Cough 12/62 (19.4%) 15 10/64 (15.6%) 16
    Pulmonary - Other (Specify) 13/62 (21%) 17 0/64 (0%) 0
    Pulmonary/Upper Respiratory - Other (Specify) 0/62 (0%) 0 15/64 (23.4%) 23
    Voice Changes 2/62 (3.2%) 2 1/64 (1.6%) 1
    Skin and subcutaneous tissue disorders
    Urticaria 2/62 (3.2%) 2 2/64 (3.1%) 2
    Rash 1/62 (1.6%) 1 0/64 (0%) 0
    Dermatology/Skin - Other 6/62 (9.7%) 8 4/64 (6.3%) 4
    Bruising 1/62 (1.6%) 1 0/64 (0%) 0
    Pruritus 1/62 (1.6%) 1 2/64 (3.1%) 3
    Ulceration 1/62 (1.6%) 1 0/64 (0%) 0
    Injection Site Reaction 1/62 (1.6%) 1 0/64 (0%) 0
    Decubitus 1/62 (1.6%) 1 0/64 (0%) 0
    Wound Compilation - Non-Infectious 1/62 (1.6%) 1 0/64 (0%) 0
    Nail Changes 0/62 (0%) 0 1/64 (1.6%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Seema Khan, MD
    Organization NorthwesternU
    Phone 312-695-0288
    Email skhan@nmh.org
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00290758
    Other Study ID Numbers:
    • NCI-2009-00840
    • NCI-2009-00840
    • CDR0000652922
    • NCI-04B3
    • NWU03-1-04
    • N01CN35157
    First Posted:
    Feb 13, 2006
    Last Update Posted:
    Feb 8, 2017
    Last Verified:
    Dec 1, 2016