Trial Outcomes & Findings for Genistein in Preventing Breast Cancer in Women at High Risk for Breast Cancer (NCT NCT00290758)
NCT ID: NCT00290758
Last Updated: 2017-02-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
126 participants
Primary outcome timeframe
6 months - baseline
Results posted on
2017-02-08
Participant Flow
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.
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.
Participant milestones
| Measure |
Arm A (Genistein)
Patients received oral genistein once daily for 6 months
|
Arm B (Placebo)
Patients received oral placebo once daily for 6 months
|
|---|---|---|
|
Pre-Intervention rFNA Through Follow-Up
STARTED
|
62
|
64
|
|
Pre-Intervention rFNA Through Follow-Up
First rFNA Tissue Collection
|
62
|
64
|
|
Pre-Intervention rFNA Through Follow-Up
Randomization
|
62
|
62
|
|
Pre-Intervention rFNA Through Follow-Up
Treatment
|
61
|
64
|
|
Pre-Intervention rFNA Through Follow-Up
Post Intervention Follow-Up
|
55
|
54
|
|
Pre-Intervention rFNA Through Follow-Up
COMPLETED
|
55
|
54
|
|
Pre-Intervention rFNA Through Follow-Up
NOT COMPLETED
|
7
|
10
|
|
Post Intervention rFNA
STARTED
|
55
|
54
|
|
Post Intervention rFNA
COMPLETED
|
49
|
49
|
|
Post Intervention rFNA
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Arm A (Genistein)
Patients received oral genistein once daily for 6 months
|
Arm B (Placebo)
Patients received oral placebo once daily for 6 months
|
|---|---|---|
|
Pre-Intervention rFNA Through Follow-Up
Adverse Event
|
1
|
2
|
|
Pre-Intervention rFNA Through Follow-Up
ConMeds
|
1
|
0
|
|
Pre-Intervention rFNA Through Follow-Up
Physician Decision
|
3
|
1
|
|
Pre-Intervention rFNA Through Follow-Up
Lost to Follow-up
|
1
|
1
|
|
Pre-Intervention rFNA Through Follow-Up
Withdrawal by Subject
|
0
|
5
|
|
Pre-Intervention rFNA Through Follow-Up
Medical Contraindication
|
1
|
0
|
|
Pre-Intervention rFNA Through Follow-Up
Non Compliant
|
0
|
1
|
|
Post Intervention rFNA
<4000 Epithelial Cells
|
6
|
5
|
Baseline Characteristics
Genistein in Preventing Breast Cancer in Women at High Risk for Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=62 Participants
Patients receive oral genistein once daily for up to 6 months.
|
Arm B
n=64 Participants
Patients receive oral placebo once daily for up to 6 months.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Gender
Female
|
62 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months - baselinePopulation: 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.
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.
Outcome measures
| Measure |
Arm A (Genistein)
n=49 Participants
Patients receive oral genistein once daily for up to 6 months.
|
Arm B (Placebo)
n=49 Participants
Patients receive oral placebo once daily for up to 6 months.
|
|---|---|---|
|
Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling
Postmenopausal with ER- Cancer
|
.325 Ki-67 labeling index
Standard Deviation .343
|
.289 Ki-67 labeling index
Standard Deviation .541
|
|
Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling
Postmenopausal with ER+ Cancer
|
-.418 Ki-67 labeling index
Standard Deviation .191
|
-.461 Ki-67 labeling index
Standard Deviation .458
|
|
Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling
Postmenopausal Without Cancer
|
-.092 Ki-67 labeling index
Standard Deviation .525
|
-.122 Ki-67 labeling index
Standard Deviation .735
|
|
Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling
Premonopausal with ER- Cancer
|
-.335 Ki-67 labeling index
Standard Deviation .930
|
.873 Ki-67 labeling index
Standard Deviation .786
|
|
Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling
Premenopausal with ER+ Cancer
|
-.387 Ki-67 labeling index
Standard Deviation .806
|
-.204 Ki-67 labeling index
Standard Deviation 1.329
|
|
Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling
Premenopausal without cancer
|
1.171 Ki-67 labeling index
Standard Deviation 2.922
|
0.557 Ki-67 labeling index
Standard Deviation 1.546
|
SECONDARY outcome
Timeframe: 6 months - baselinePopulation: 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.
Mean change in the concentration of EGF found in nipple aspirate fluid is assessed from baseline to 6 month follow up.
Outcome measures
| Measure |
Arm A (Genistein)
n=23 Participants
Patients receive oral genistein once daily for up to 6 months.
|
Arm B (Placebo)
n=20 Participants
Patients receive oral placebo once daily for up to 6 months.
|
|---|---|---|
|
Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF)
Postmenopausal with ER- Cancer
|
-133.07 ng/ml
Standard Deviation 308.28
|
—
|
|
Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF)
Postmenopausal with ER+ Cancer
|
—
|
-197.8 ng/ml
Standard Deviation 16.01
|
|
Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF)
Postmenopausal without cancer
|
201.05 ng/ml
Standard Deviation 380.72
|
-38.74 ng/ml
Standard Deviation 226.18
|
|
Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF)
Premenopausal with ER- Cancer
|
-93.23 ng/ml
Standard Deviation 0
|
37.38 ng/ml
Standard Deviation 69.11
|
|
Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF)
Premenopausal with ER+ Cancer
|
—
|
20.63 ng/ml
Standard Deviation 0
|
|
Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF)
Premenopausal without cancer
|
-9.16 ng/ml
Standard Deviation 296.55
|
-9.26 ng/ml
Standard Deviation 175.57
|
SECONDARY outcome
Timeframe: 6 months - baselinePopulation: Analysis performed by menopause and cancer status.
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.
Outcome measures
| Measure |
Arm A (Genistein)
n=49 Participants
Patients receive oral genistein once daily for up to 6 months.
|
Arm B (Placebo)
n=49 Participants
Patients receive oral placebo once daily for up to 6 months.
|
|---|---|---|
|
Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells.
Postmenopausal with ER- Cancer
|
-1.25 Percent pixels
Standard Deviation 0.96
|
0 Percent pixels
Standard Deviation 0
|
|
Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells.
Postmenopausal with ER+ Cancer
|
-3.00 Percent pixels
Standard Deviation 2.12
|
-.40 Percent pixels
Standard Deviation 0.89
|
|
Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells.
Postmenopausal Without Cancer
|
-0.50 Percent pixels
Standard Deviation 1.87
|
0 Percent pixels
Standard Deviation 1.45
|
|
Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells.
Premenopausal with ER- Cancer
|
0.50 Percent pixels
Standard Deviation 0.71
|
0 Percent pixels
Standard Deviation 0
|
|
Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells.
Premenopausal with ER+ Cancer
|
0.50 Percent pixels
Standard Deviation 1.29
|
-0.75 Percent pixels
Standard Deviation 0.96
|
|
Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells.
Premenopausal without cancer
|
0.17 Percent pixels
Standard Deviation 2.42
|
0.95 Percent pixels
Standard Deviation 2.18
|
SECONDARY outcome
Timeframe: 6 months - baselinePopulation: 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.
Mean change in concentration of estradiol measured in nipple aspiration fluid assessed from baseline to 6 month follow up.
Outcome measures
| Measure |
Arm A (Genistein)
n=21 Participants
Patients receive oral genistein once daily for up to 6 months.
|
Arm B (Placebo)
n=19 Participants
Patients receive oral placebo once daily for up to 6 months.
|
|---|---|---|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Estradiol
Postmenopausal with ER- Cancer
|
2251.92 pg/ml
Standard Deviation 292.66
|
—
|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Estradiol
Postmenopausal with ER+ Cancer
|
—
|
-497.3 pg/ml
Standard Deviation 0
|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Estradiol
Postmenopausal Without Cancer
|
-354.39 pg/ml
Standard Deviation 643.44
|
925.83 pg/ml
Standard Deviation 955.71
|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Estradiol
Premenopausal with ER- Cancer
|
-129.58 pg/ml
Standard Deviation 0
|
-36.38 pg/ml
Standard Deviation 16.42
|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Estradiol
Premenopausal without cancer
|
-591.81 pg/ml
Standard Deviation 992.24
|
6.31 pg/ml
Standard Deviation 394.74
|
SECONDARY outcome
Timeframe: 6 months - baselinePopulation: Analysis performed by menopause and cancer status.
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.
Outcome measures
| Measure |
Arm A (Genistein)
n=49 Participants
Patients receive oral genistein once daily for up to 6 months.
|
Arm B (Placebo)
n=49 Participants
Patients receive oral placebo once daily for up to 6 months.
|
|---|---|---|
|
Monitor Drug Delivery by Measuring Plasma Genistein by HPLC
Postmenopausal with ER- Cancer
|
368.62 ng/ml
Standard Deviation 389.24
|
0 ng/ml
Standard Deviation 0
|
|
Monitor Drug Delivery by Measuring Plasma Genistein by HPLC
Postmenopausal with ER+ Cancer
|
65.20 ng/ml
Standard Deviation 92.20
|
0 ng/ml
Standard Deviation 0
|
|
Monitor Drug Delivery by Measuring Plasma Genistein by HPLC
Postmenopausal Without Cancer
|
190.42 ng/ml
Standard Deviation 226.17
|
0.65 ng/ml
Standard Deviation 2.52
|
|
Monitor Drug Delivery by Measuring Plasma Genistein by HPLC
Premenopausal with ER- Cancer
|
472.09 ng/ml
Standard Deviation 350.16
|
4.56 ng/ml
Standard Deviation 6.44
|
|
Monitor Drug Delivery by Measuring Plasma Genistein by HPLC
Premenopausal with ER+ Cancer
|
423.12 ng/ml
Standard Deviation 359.00
|
3.80 ng/ml
Standard Deviation 4.40
|
|
Monitor Drug Delivery by Measuring Plasma Genistein by HPLC
Premenopausal without cancer
|
269.88 ng/ml
Standard Deviation 250.43
|
3.57 ng/ml
Standard Deviation 14.99
|
SECONDARY outcome
Timeframe: 6 months - baselinePopulation: Plasma concentration of SHBG was not available for 1 patient in Arm A. Analysis performed by menopause and cancer status.
Outcome measures
| Measure |
Arm A (Genistein)
n=48 Participants
Patients receive oral genistein once daily for up to 6 months.
|
Arm B (Placebo)
n=49 Participants
Patients receive oral placebo once daily for up to 6 months.
|
|---|---|---|
|
Plasma Concentration of Sex Hormone Binding Globulin (SHBG)
Postmenopausal with ER- Cancer
|
7.39 nmol/L
Standard Deviation 28.64
|
22.07 nmol/L
Standard Deviation 50.65
|
|
Plasma Concentration of Sex Hormone Binding Globulin (SHBG)
Postmenopausal with ER+ Cancer
|
-17.84 nmol/L
Standard Deviation 0.55
|
-8.12 nmol/L
Standard Deviation 13.40
|
|
Plasma Concentration of Sex Hormone Binding Globulin (SHBG)
Postmenopausal Without Cancer
|
3.94 nmol/L
Standard Deviation 26.42
|
-20.49 nmol/L
Standard Deviation 50.03
|
|
Plasma Concentration of Sex Hormone Binding Globulin (SHBG)
Premenopausal with ER- Cancer
|
15.61 nmol/L
Standard Deviation 14.79
|
-27.34 nmol/L
Standard Deviation 12.13
|
|
Plasma Concentration of Sex Hormone Binding Globulin (SHBG)
Premenopausal with ER+ Cancer
|
1.99 nmol/L
Standard Deviation 15.26
|
-14.79 nmol/L
Standard Deviation 17.41
|
|
Plasma Concentration of Sex Hormone Binding Globulin (SHBG)
Premenopausal without cancer
|
-11.18 nmol/L
Standard Deviation 39.90
|
3.79 nmol/L
Standard Deviation 29.96
|
SECONDARY outcome
Timeframe: 6 months - baselinePopulation: 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.
Mean change in concentration of Cathepsin D measured in nipple aspiration fluid assessed from baseline to 6 month follow up.
Outcome measures
| Measure |
Arm A (Genistein)
n=23 Participants
Patients receive oral genistein once daily for up to 6 months.
|
Arm B (Placebo)
n=21 Participants
Patients receive oral placebo once daily for up to 6 months.
|
|---|---|---|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D
post menopausal with ER- cancer
|
-3105.29 mg/ml
Standard Deviation 6764.20
|
—
|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D
post menopasual with ER+ caner
|
—
|
-3961.16 mg/ml
Standard Deviation 1295.29
|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D
post menopausal without cancer
|
3362.326 mg/ml
Standard Deviation 9545.02
|
-1774.72 mg/ml
Standard Deviation 17644.27
|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D
pre menopausal with ER- cancer
|
1800.40 mg/ml
Standard Deviation 0
|
29337.79 mg/ml
Standard Deviation 36645.39
|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D
pre menopausal with ER+ cancer
|
—
|
-6218.25 mg/ml
Standard Deviation 0
|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D
Pre menopausal without Cancer
|
-4904.09 mg/ml
Standard Deviation 28128.12
|
486.56 mg/ml
Standard Deviation 40420.50
|
SECONDARY outcome
Timeframe: 6 month - baselinePopulation: 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.
Mean change in concentration of protein ps2 measured in nipple aspiration fluid assessed from baseline to 6 month follow up.
Outcome measures
| Measure |
Arm A (Genistein)
n=23 Participants
Patients receive oral genistein once daily for up to 6 months.
|
Arm B (Placebo)
n=21 Participants
Patients receive oral placebo once daily for up to 6 months.
|
|---|---|---|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2
Post menopausal with ER- cancer
|
-28.00 ng/ml
Standard Deviation 41.85
|
—
|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2
Post menopasual with ER+ caner
|
—
|
-61.06 ng/ml
Standard Deviation 10.06
|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2
Post menopausal without cancer
|
-14.17 ng/ml
Standard Deviation 32.40
|
-6.10 ng/ml
Standard Deviation 65.38
|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2
Pre menopausal with ER- cancer
|
-16.68 ng/ml
Standard Deviation 0
|
4.69 ng/ml
Standard Deviation 23.75
|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2
Pre menopausal with ER+ cancer
|
—
|
-31.46 ng/ml
Standard Deviation 0
|
|
Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2
Pre menopausal without Cancer
|
-20.49 ng/ml
Standard Deviation 54.30
|
12.17 ng/ml
Standard Deviation 29.74
|
Adverse Events
Arm A (Genistein)
Serious events: 6 serious events
Other events: 50 other events
Deaths: 0 deaths
Arm B (Placebo)
Serious events: 1 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Genistein)
n=62 participants at risk
Patients take oral genistein once daily for up to 6 months.
|
Arm B (Placebo)
n=64 participants at risk
Patients take oral placebo once daily for up to 6 months.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Nervous system disorders
Mood Alteration: Depression
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Renal and urinary disorders
renal - Other
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Renal and urinary disorders
Obstruction, GU: Uterus
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Reproductive system and breast disorders
Sexual
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Dyspnea
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
Other adverse events
| Measure |
Arm A (Genistein)
n=62 participants at risk
Patients take oral genistein once daily for up to 6 months.
|
Arm B (Placebo)
n=64 participants at risk
Patients take oral placebo once daily for up to 6 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemorrhage - Other
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Blood and lymphatic system disorders
Hemorrhage with Surgery
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Blood and lymphatic system disorders
Hematoma
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Blood and lymphatic system disorders
Blood/bone marrow: Blood- Other
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Blood and lymphatic system disorders
Leukocytes
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Blood and lymphatic system disorders
Edima: Limb
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Blood and lymphatic system disorders
Coagulation - Other
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Cardiac disorders
Hypotension
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Cardiac disorders
Supraventricular Arrythmia - Select Sinus Bradycardia
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Cardiac disorders
Cardia Ischemia/Infarction
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Cardiac disorders
Hypertension
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Cardiac disorders
Palpitations
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Endocrine disorders
Hot Flashes
|
16.1%
10/62 • Number of events 11 • 3 years
February, 2006 th March, 2009
|
12.5%
8/64 • Number of events 10 • 3 years
February, 2006 th March, 2009
|
|
Endocrine disorders
Hypothyroidism
|
4.8%
3/62 • Number of events 3 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Endocrine disorders
Endocrine - Other
|
1.6%
1/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Eye disorders
Blurred Vision
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Eye disorders
Other
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Eye disorders
Ocular - Other
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
3.1%
2/64 • Number of events 4 • 3 years
February, 2006 th March, 2009
|
|
Eye disorders
Flashing Lights
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
5/62 • Number of events 5 • 3 years
February, 2006 th March, 2009
|
7.8%
5/64 • Number of events 6 • 3 years
February, 2006 th March, 2009
|
|
Gastrointestinal disorders
Diarrhea
|
9.7%
6/62 • Number of events 6 • 3 years
February, 2006 th March, 2009
|
7.8%
5/64 • Number of events 6 • 3 years
February, 2006 th March, 2009
|
|
Gastrointestinal disorders
nausea
|
8.1%
5/62 • Number of events 5 • 3 years
February, 2006 th March, 2009
|
3.1%
2/64 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
|
Gastrointestinal disorders
Heartburn
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
4.7%
3/64 • Number of events 3 • 3 years
February, 2006 th March, 2009
|
|
Gastrointestinal disorders
Constipation
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Gastrointestinal disorders
GI - Other
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Other
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Throat/Pharynx/Larynx
|
4.8%
3/62 • Number of events 3 • 3 years
February, 2006 th March, 2009
|
6.2%
4/64 • Number of events 5 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Larynx
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Back
|
6.5%
4/62 • Number of events 7 • 3 years
February, 2006 th March, 2009
|
4.7%
3/64 • Number of events 5 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Joint
|
4.8%
3/62 • Number of events 6 • 3 years
February, 2006 th March, 2009
|
9.4%
6/64 • Number of events 7 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Breast
|
6.5%
4/62 • Number of events 5 • 3 years
February, 2006 th March, 2009
|
7.8%
5/64 • Number of events 5 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Extremity - Limb
|
1.6%
1/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
6.2%
4/64 • Number of events 5 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Head/Headaches
|
9.7%
6/62 • Number of events 9 • 3 years
February, 2006 th March, 2009
|
9.4%
6/64 • Number of events 6 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Cardiac/Heart
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Abdomen Nos
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Neuralgia
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Eye
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Bone
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Skin
|
3.2%
2/62 • Number of events 4 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Uterus
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Pain - Select: Dental/Teeth/Peridontal
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Constitutional Symptoms - Other
|
4.8%
3/62 • Number of events 3 • 3 years
February, 2006 th March, 2009
|
6.2%
4/64 • Number of events 5 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Constitutional Symptoms - Weight Gain
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Constitutional Symptoms - Fever
|
16.1%
10/62 • Number of events 10 • 3 years
February, 2006 th March, 2009
|
3.1%
2/64 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Constitutional Symptoms - Fatigue
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
4.7%
3/64 • Number of events 4 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Constitutional Symptoms - Insomnia
|
4.8%
3/62 • Number of events 3 • 3 years
February, 2006 th March, 2009
|
3.1%
2/64 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Constitutional Symptoms - Rigors/Chills
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
General disorders
Constitutional Symptoms - Sweating
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Immune system disorders
Allergic Reastion
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 6 • 3 years
February, 2006 th March, 2009
|
|
Infections and infestations
Infection (documented clinically) Select: Bladder (Urinary)
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Infections and infestations
Infection with Unknown ANC - Select: Bronchus
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Infections and infestations
Infections - Other
|
4.8%
3/62 • Number of events 3 • 3 years
February, 2006 th March, 2009
|
7.8%
5/64 • Number of events 5 • 3 years
February, 2006 th March, 2009
|
|
Infections and infestations
Infection with Unknwn ANC - Select: Vagina
|
4.8%
3/62 • Number of events 3 • 3 years
February, 2006 th March, 2009
|
3.1%
2/64 • Number of events 4 • 3 years
February, 2006 th March, 2009
|
|
Infections and infestations
Infection with Unknown ANC - Select: Skin (Cellulitis)
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Infections and infestations
Infection (Documented ClinicallY) - Select: Vagina
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Infections and infestations
Infection With Unknown ANC - Select: Upper Airways Nose
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
|
Infections and infestations
Infection With Unknown ANC - Select: Sinus
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Infections and infestations
Infection With Unknown ANC - Select: Urinary Tract Nos
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
3.1%
2/64 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
|
Infections and infestations
Infection (Documented Clinically) - Select: Sinus
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Infections and infestations
Infection With Unknown ANC - Select: Conjunctiva
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Infections and infestations
Infection (Documented Clinically) - Select: Urinary Tract Nos
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Infections and infestations
Infection (Documented Clinically) - Select: Pleura (Empyema)
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Metabolism and nutrition disorders
ALt
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Metabolism and nutrition disorders
AST
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Metabolism and nutrition disorders
Cholesterol
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - Other (Specify)
|
12.9%
8/62 • Number of events 10 • 3 years
February, 2006 th March, 2009
|
7.8%
5/64 • Number of events 7 • 3 years
February, 2006 th March, 2009
|
|
Musculoskeletal and connective tissue disorders
Joint - Function
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Nervous system disorders
Mood Alteration - Select: Anxiety
|
6.5%
4/62 • Number of events 4 • 3 years
February, 2006 th March, 2009
|
3.1%
2/64 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
|
Nervous system disorders
Mood Alteration - Select: Depression
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Nervous system disorders
Dizziness
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Nervous system disorders
Neurology (Other)
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Nervous system disorders
Tremor
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Renal and urinary disorders
Incontinence, Urinary
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Renal and urinary disorders
Obstruction, GU - Select:: Uterus
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Renal and urinary disorders
Cystitis
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Renal and urinary disorders
Renal - Other
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Renal and urinary disorders
Urinary Frequesncy
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Reproductive system and breast disorders
Sexual - Other
|
9.7%
6/62 • Number of events 6 • 3 years
February, 2006 th March, 2009
|
12.5%
8/64 • Number of events 12 • 3 years
February, 2006 th March, 2009
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
12/62 • Number of events 15 • 3 years
February, 2006 th March, 2009
|
15.6%
10/64 • Number of events 16 • 3 years
February, 2006 th March, 2009
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other (Specify)
|
21.0%
13/62 • Number of events 17 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify)
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
23.4%
15/64 • Number of events 23 • 3 years
February, 2006 th March, 2009
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.2%
2/62 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
3.1%
2/64 • Number of events 2 • 3 years
February, 2006 th March, 2009
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
9.7%
6/62 • Number of events 8 • 3 years
February, 2006 th March, 2009
|
6.2%
4/64 • Number of events 4 • 3 years
February, 2006 th March, 2009
|
|
Skin and subcutaneous tissue disorders
Bruising
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
3.1%
2/64 • Number of events 3 • 3 years
February, 2006 th March, 2009
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Skin and subcutaneous tissue disorders
Decubitus
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Skin and subcutaneous tissue disorders
Wound Compilation - Non-Infectious
|
1.6%
1/62 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
0.00%
0/64 • 3 years
February, 2006 th March, 2009
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
0.00%
0/62 • 3 years
February, 2006 th March, 2009
|
1.6%
1/64 • Number of events 1 • 3 years
February, 2006 th March, 2009
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60