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

About this trial
This is an interventional prevention trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I (genistein)
Arm II (placebo)
Patients receive oral genistein once daily for up to 6 months.
Patients receive oral placebo once daily for up to 6 months.