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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00290758 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: genistein Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | Phase IIb Trial of Genistein in Women At High Risk For Breast Cancer |
Estimated Enrollment: | 134 |
Study Start Date: | January 2006 |
Arms | Assigned Interventions |
---|---|
Arm I: Experimental
Patients receive oral genistein once daily for up to 6 months.
|
Drug: genistein
Given orally
|
Arm II: Placebo Comparator
Patients receive oral placebo once daily for up to 6 months.
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Drug: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
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.
After completion of study treatment, patients are followed at 30-37 days.
PROJECTED ACCRUAL: A total of 134 patients will be accrued for this study.
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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:
Estimated 5-year risk of developing breast cancer using the Claus model
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
None of the following for ≥ 2 weeks before the first random fine needle aspiration and during study participation:
United States, Illinois | |
Lynn Sage Comprehensive Breast Center at Northwestern Memorial Hospital | |
Chicago, Illinois, United States, 60611 | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
Chicago, Illinois, United States, 60611 |
Study Chair: | Seema A. Khan, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000466517, NU-NWU03-1-04, NU-NCI-04B3, NU-0835-030 |
Study First Received: | February 9, 2006 |
Last Updated: | August 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00290758 |
Health Authority: | United States: Food and Drug Administration |
breast cancer |
Skin Diseases Breast Neoplasms Genistein Breast Diseases |
Anticarcinogenic Agents Estrogens Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Protein Kinase Inhibitors |
Hormones Protective Agents Pharmacologic Actions Neoplasms Neoplasms by Site Estrogens, Non-Steroidal Therapeutic Uses Phytoestrogens |