Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Completed	18 and over	NCI	MCC-0104 NCI-5348, NCI-P02-0214, NCT00036686

Objectives

1. 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.
2. Determine the effect of soy protein isolate on serum isoflavone levels in these patients.
3. Correlate changes in serum isoflavones with changes in cell proliferation, apoptosis, and hormonal levels in patients treated with this therapy.
4. Correlate the changes in cell proliferation and apoptosis with hormonal markers in patients treated with this therapy.

Entry Criteria

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

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

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)

Expected Enrollment

A total of 106 patients (53 per treatment arm) will be accrued for this study within 18 months.

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.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center CCOP Research Base

Nagi Kumar, PhD, RD, FADA, Protocol chair		Ph: 813-745-6885; 888-663-3488

Registry Information
Official Title		A Clinical Trial of the Action of Isoflavones in Breast Neoplasia: Administration Prior to Mastectomy or Lumpectomy-A Pilot Study
Trial Start Date		2002-03-15
Trial Completion Date		2003-10-27
Registered in ClinicalTrials.gov		NCT00036686
Date Submitted to PDQ		2002-01-16
Information Last Verified		2006-09-28

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