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Home > "S" Clinical Trials Conditions > Soy Isoflavone Compared With No Treatment Before Surgery in Treating Patients With Breast Cancer  Soy Isoflavone Compared With No Treatment Before Surgery in Treating Patients With Breast Cancer
Soy Isoflavone Compared With No Treatment Before Surgery in Treating Patients With Breast Cancer
For Condition: stage 3C breast cancer,stage 2 breast cancer,stage 1 breast cancer,stage 3A breast cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Soy isoflavone may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if isoflavone is more effective than no treatment before surgery for breast cancer. PURPOSE: Randomizedphase II trial to study the effectiveness of soy isoflavone compared with no treatment before surgery in treating patients who have breast cancer.
Details: OBJECTIVES: - Determine the effect of soy isoflavone on angiogenesis and proliferation in patients with breast cancer. - Determine the effect of this regimen on antiangiogenic growth factors and blood vessel density in these patients. - Determine the anti-proliferative effect of this regimen, by measurement of Ki67 index, DNA flow analysis, and apoptosis index, in these patients. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. - Arm I: Patients receive oral soy isoflavone daily for 2 weeks prior to surgery. - Arm II: Patients receive no therapy prior to surgery. All patients undergo lumpectomy or mastectomy. PROJECTED ACCRUAL: A total of 68 patients (34 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of breast cancer - Scheduled to undergo lumpectomy or mastectomy - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - Adult Sex: - Not specified Menopausal status: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No allergy to soy PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaiBrooks, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1782
United States
Recruiting Mai Brooks 310-206-2215
Additional Information:
Study ID Numbers: CDR0000068800; UCLA-0005093,NCI-G01-1994
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022269
Other Stage 3c Breast Cancer Studies:
1. Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy
2. Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
3. Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer
4. Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer
5. Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer
Related Studies:
Other stage 3C breast cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Soy Isoflavone Compared With No Treatment Before Surgery in Treating Patients With Breast Cancer
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