Trial · NCT00290758
Genistein in Preventing Breast Cancer in Women at High Risk for Breast Cancer
NCT00290758, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-02-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Genistein in Preventing Breast Cancer in Women at High Risk for Breast Cancer. Trials, record NCT00290758. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00290758
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Genistein in Preventing Breast Cancer in Women at High Risk for Breast Cancer
- NCT number
- NCT00290758
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 126 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Breast Cancer
- Interventions
- placebo, genistein, laboratory biomarker analysis
- First posted
- 2006-02-13
- Last updated
- 2017-02-08
- Results first posted
- 2017-02-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Plasma Concentration of Sex Hormone Binding Globulin (SHBG) | 6 months - baseline | |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling | 6 months - baseline | 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. | Ki-67 labeling index | MEAN |
| SECONDARY | Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF) | 6 months - baseline | 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. | ng/ml | MEAN |
| SECONDARY | Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells. | 6 months - baseline | Analysis performed by menopause and cancer status. | Percent pixels | MEAN |
| SECONDARY | Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Estradiol | 6 months - baseline | 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. | pg/ml | MEAN |
| SECONDARY | Monitor Drug Delivery by Measuring Plasma Genistein by HPLC | 6 months - baseline | Analysis performed by menopause and cancer status. | ng/ml | MEDIAN |
| SECONDARY | Plasma Concentration of Sex Hormone Binding Globulin (SHBG) | 6 months - baseline | Plasma concentration of SHBG was not available for 1 patient in Arm A. Analysis performed by menopause and cancer status. | nmol/L | MEAN |
| SECONDARY | Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D | 6 months - baseline | 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. | mg/ml | MEAN |
| SECONDARY | Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2 | 6 month - baseline | 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. | ng/ml | MEAN |
Source ClinicalTrials.gov
Results by group83
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling | Arm A (Genistein) | Postmenopausal with ER- Cancer | .325 | Standard Deviation .343 | Ki-67 labeling index |
| Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling | Arm B (Placebo) | Postmenopausal with ER- Cancer | .289 | Standard Deviation .541 | Ki-67 labeling index |
| Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling | Arm A (Genistein) | Postmenopausal with ER+ Cancer | -.418 | Standard Deviation .191 | Ki-67 labeling index |
| Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling | Arm B (Placebo) | Postmenopausal with ER+ Cancer | -.461 | Standard Deviation .458 | Ki-67 labeling index |
| Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling | Arm A (Genistein) | Postmenopausal Without Cancer | -.092 | Standard Deviation .525 | Ki-67 labeling index |
| Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling | Arm B (Placebo) | Postmenopausal Without Cancer | -.122 | Standard Deviation .735 | Ki-67 labeling index |
| Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling | Arm A (Genistein) | Premonopausal with ER- Cancer | -.335 | Standard Deviation .930 | Ki-67 labeling index |
| Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling | Arm B (Placebo) | Premonopausal with ER- Cancer | .873 | Standard Deviation .786 | Ki-67 labeling index |
| Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling | Arm A (Genistein) | Premenopausal with ER+ Cancer | -.387 | Standard Deviation .806 | Ki-67 labeling index |
| Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling | Arm B (Placebo) | Premenopausal with ER+ Cancer | -.204 | Standard Deviation 1.329 | Ki-67 labeling index |
1 to 10 of 83Source ClinicalTrials.gov
See all 83 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-Intervention rFNA Through Follow-Up | STARTED | Arm A (Genistein) | 62 | |
| Pre-Intervention rFNA Through Follow-Up | STARTED | Arm B (Placebo) | 64 | |
| Pre-Intervention rFNA Through Follow-Up | First rFNA Tissue Collection | Arm A (Genistein) | 62 | |
| Pre-Intervention rFNA Through Follow-Up | First rFNA Tissue Collection | Arm B (Placebo) | 64 | |
| Pre-Intervention rFNA Through Follow-Up | Randomization | Arm A (Genistein) | 62 | |
| Pre-Intervention rFNA Through Follow-Up | Randomization | Arm B (Placebo) | 62 | |
| Pre-Intervention rFNA Through Follow-Up | Treatment | Arm A (Genistein) | 61 | |
| Pre-Intervention rFNA Through Follow-Up | Treatment | Arm B (Placebo) | 64 | |
| Pre-Intervention rFNA Through Follow-Up | Post Intervention Follow-Up | Arm A (Genistein) | 55 | |
| Pre-Intervention rFNA Through Follow-Up | Post Intervention Follow-Up | Arm B (Placebo) | 54 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events212
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hemorrhage - Other | Blood and lymphatic system disorders | Arm A (Genistein) | 1 | 62 | 1 |
| other | Hemorrhage - Other | Blood and lymphatic system disorders | Arm B (Placebo) | 0 | 64 | 0 |
| other | Hemorrhage with Surgery | Blood and lymphatic system disorders | Arm A (Genistein) | 1 | 62 | 1 |
| other | Hemorrhage with Surgery | Blood and lymphatic system disorders | Arm B (Placebo) | 0 | 64 | 0 |
| other | Hematoma | Blood and lymphatic system disorders | Arm A (Genistein) | 1 | 62 | 1 |
| other | Hematoma | Blood and lymphatic system disorders | Arm B (Placebo) | 1 | 64 | 1 |
| other | Blood/bone marrow: Blood- Other | Blood and lymphatic system disorders | Arm A (Genistein) | 1 | 62 | 1 |
| other | Blood/bone marrow: Blood- Other | Blood and lymphatic system disorders | Arm B (Placebo) | 1 | 64 | 1 |
| other | Hemoglobin | Blood and lymphatic system disorders | Arm A (Genistein) | 1 | 62 | 1 |
| other | Hemoglobin | Blood and lymphatic system disorders | Arm B (Placebo) | 0 | 64 | 0 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Genistein) | ||
| Total, all-cause mortality | Arm B (Placebo) | ||
| Total, other adverse events | Arm A (Genistein) | 50 | 62 |
| Total, other adverse events | Arm B (Placebo) | 56 | 64 |
| Total, serious adverse events | Arm A (Genistein) | 6 | 62 |
| Total, serious adverse events | Arm B (Placebo) | 1 | 64 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22307566 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| N01CN035157 | PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS-2-261035157 | BERGAN, RAYMOND C | NORTHWESTERN UNIVERSITY | DIVISION OF CANCER PREVENTION AND CONTROL | 2004 to 2006 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm A (Genistein) vs Arm B (Placebo): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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