Phase IIb Trial of G-2535 (Unconjugated Isoflavones-100) in Women at High Risk for Breast Cancer
This trial is active, not recruiting.
|Collaborator||National Cancer Institute (NCI)|
|Start date||January 2006|
|End date||August 2008|
|Trial size||126 participants|
|Trial identifier||NCT00290758, NCI 04B3, NWU03-1-04|
RATIONALE: 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.
PURPOSE: This randomized phase II trial is studying how well genistein works in preventing breast cancer in women at high risk for breast cancer.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Patients receive oral genistein once daily for up to 6 months.
Patients receive oral placebo once daily for up to 6 months.
Determine effect upon proliferation of breast epithelial cells obtained by fine needle aspiration (FNA)
time frame: At screening and at six months
Epithelial cells obtained by FNA
time frame: At screening and at six months
Nipple aspirate fluid
time frame: At secondary screening and at six months
time frame: At presreening; secondary screening (if less than 45 years with intact ovaries); at day one, at one month and six months
Female participants at least 25 years old.
DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: - Female patient - 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 known soy intolerance - 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 PRIOR CONCURRENT THERAPY: - See Disease Characteristics - 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
|Official title||Phase IIb Trial of G-2535 (Unconjugated Isoflavones-100) in Women at High Risk for Breast Cancer|
|Description||OBJECTIVES: Primary - 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. Secondary - 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. PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.|
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