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Clinical Trial: Soy Isoflavone Compared With No Treatment Before Surgery in Treating Patients With Breast Cancer
This study is no longer recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIC breast cancer | Drug: soy protein isolate Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological response modifier therapy Procedure: biologically based therapies Procedure: cancer prevention intervention Procedure: complementary and alternative therapy Procedure: conventional surgery Procedure: dietary modification Procedure: growth factor antagonist therapy Procedure: herbal medicine / botanical therapy Procedure: neoadjuvant therapy Procedure: nutritional supplementation Procedure: phytoestrogen therapy Procedure: surgery | Phase II |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Randomized Study of Soy Isoflavone in Patients With Breast Cancer
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
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location Information
California
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1782, United States
Mai N. Brooks, MD, Study Chair, Jonsson Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: July 2004
Last Updated: October 13, 2004
Record first received: August 10, 2001
ClinicalTrials.gov Identifier: NCT00022269
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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