Genistein in Preventing Breast Cancer in Women at High Risk for Breast Cancer
|ClinicalTrials.gov Identifier: NCT00290758|
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : February 8, 2017
Last Update Posted : February 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: placebo Drug: genistein Other: laboratory biomarker analysis||Phase 2|
I. 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.
I. 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase IIB Trial of G-2535 (Unconjugated Isoflavones-100) in Women at High Risk for Breast Cancer|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||July 2009|
Experimental: Arm I (genistein)
Patients receive oral genistein once daily for up to 6 months.
Other: laboratory biomarker analysis
Placebo Comparator: Arm II (placebo)
Patients receive oral placebo once daily for up to 6 months.
Other Name: PLCB
- Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling [ Time Frame: 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.
- Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF) [ Time Frame: 6 months - baseline ]Mean change in the concentration of EGF found in nipple aspirate fluid is assessed from baseline to 6 month follow up.
- Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells. [ Time Frame: 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.
- Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Estradiol [ Time Frame: 6 months - baseline ]Mean change in concentration of estradiol measured in nipple aspiration fluid assessed from baseline to 6 month follow up.
- Monitor Drug Delivery by Measuring Plasma Genistein by HPLC [ Time Frame: 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.
- Plasma Concentration of Sex Hormone Binding Globulin (SHBG) [ Time Frame: 6 months - baseline ]
- Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D [ Time Frame: 6 months - baseline ]Mean change in concentration of Cathepsin D measured in nipple aspiration fluid assessed from baseline to 6 month follow up.
- Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2 [ Time Frame: 6 month - baseline ]Mean change in concentration of protein ps2 measured in nipple aspiration fluid assessed from baseline to 6 month follow up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290758
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Seema Khan||Northwestern University|