Isoflavones in Treating Women Who Have Breast Cancer and Are Planning to Undergo Mastectomy or Lumpectomy

Study Overview
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Brief Summary
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RATIONALE: Eating a diet rich in soy foods may slow the progression of some types of cancer. Isoflavones are compounds found in soy food that may slow the growth of breast cancer cells and prevent further development of breast cancer. PURPOSE: Randomized pilot trial to study the effectiveness of isoflavones in preventing further development of breast cancer in women who are planning to undergo mastectomy or lumpectomy.

Detailed Description
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OBJECTIVES: Determine the effect of soy protein isolate (isoflavones) on modulation of intermediate endpoint biomarkers (such as cell proliferation, apoptosis, and steroid hormones) in women planning to undergo mastectomy or lumpectomy for breast cancer. Determine the effect of soy protein isolate on serum isoflavone levels in these patients. Correlate changes in serum isoflavones with changes in cell proliferation, apoptosis, and hormonal levels in patients treated with this therapy. Correlate the changes in cell proliferation and apoptosis with hormonal markers in patients treated with this therapy. OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to the phase of the menstrual cycle at time of biopsy and time of surgery (follicular phase [i.e., during first 7 days of menstrual cycle] vs luteal phase [i.e., after day 7 of the menstrual cycle]). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily. Arm II:Patients receive oral placebo twice daily and oral multivitamins once daily. In both arms, treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure. PROJECTED ACCRUAL: A total of 106 patients (53 per treatment arm) will be accrued for this study within 18 months.

Official Title
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A Clinical Trial of the Action of Isoflavones in Breast Neoplasia: Administration Prior to Mastectomy or Lumpectomy-A Pilot Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Dietary Supplement: Soy protein isolate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Undergoing breast biopsy for any stage breast cancer No excisional biopsy At least one core biopsy block must contain carcinoma Definitive surgery (mastectomy or lumpectomy) planned for 2-4 weeks after registration to this study Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Premenopausal Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No known prior hepatic disease Renal: No known prior renal disease Other: Not pregnant or nursing Fertile patients must use effective non-hormonal contraception No other prior malignancy except nonmelanoma skin cancer No known prior thyroid disease No adherence to vegan diet or other special dietary requirements that would preclude study participation No allergy to study agent No obesity (body mass index greater than 32) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent birth control pills or other hormonal therapy No concurrent thyroid hormone replacement medications Radiotherapy: Not specified Surgery: See Disease Characteristics Other: More than 30 days since prior antibiotics More than 4 weeks since prior soy products No routine consumption of greater than 40 mg of soy/day No other concurrent nutritional supplements, including modular supplements of other isoflavones

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soy protein isolate<br>Administration Prior to Mastectomy or Lumpectomy. Patients receive oral soy protein isolate twice daily and oral multivitamins once daily. Treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure. | Dietary Supplement: Soy protein isolate<br>* Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.<br>* Other names: isoflavones;|
| Placebo Comparator: Placebo<br>Administration Prior to Mastectomy or Lumpectomy. Patients receive oral placebo twice daily and oral multivitamins once daily. Treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure. | Other: Placebo<br>* Arm II: Patients receive oral placebo twice daily and oral multivitamins once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Soy Protein Isolate Effect | Determine the effect of soy protein isolate (isoflavones) on modulation of intermediate endpoint biomarkers (such as cell proliferation, apoptosis, and steroid hormones) in women planning to undergo mastectomy or lumpectomy for breast cancer. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Effect on Serum Isoflavone Levels | Determine the effect of soy protein isolate on serum isoflavone levels in these patients. | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, recurrent breast cancer, stage IV breast cancer