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

Completed · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00290758

Run by

National Cancer Institute (NCI)

People needed

126

Starts

2006-01-01

Expected to finish

2009-07-01

Last updated by the study team

2017-02-08

Who can join

Age: 25 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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