Genistein in Preventing Breast Cancer in Women at High Risk for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: placebo; genistein; laboratory biomarker analysis
Intervention description: Given orally; Given orally; Correlative studies
Intervention MeSH terms: Genistein
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 126.0
Sex: Female
Minimum age: 25 Years
Healthy volunteers: No

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.
    

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.