Clinical trial NCT01219075: Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer
Official title: Soy Treatment for High-risk Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BRCA1 Mutation Carrier
BRCA2 Mutation Carrier
Ductal Breast Carcinoma in Situ
Lobular Breast Carcinoma in Situ
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: California Breast Cancer Research Program
First posted: 2010-10-13
Enrollment: 110
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones supplements may prevent or treat early stage breast cancer. PURPOSE: This clinical trial studies soy isoflavones supplementation in treating women at high risk for or with breast cancer.

Detailed description: PRIMARY OBJECTIVES: I. To assess whether magnetic resonance imaging (MRI) volume (equivalent to 3-dimensional mammographic density) is reduced in high-risk women or those with invasive breast cancer or DCIS who are supplemented daily with soy (5p mg total isoflavones as aglycone) compared to placebo (microcrystalline cellulose) tablets for 1 year.II. To assess whether cell proliferation and apoptosis, as measured by Ki67 and caspase 3 staining, respectively, of breast epithelial cells is altered with soy treatment.SECONDARY OBJECTIVES: I. To assess whether other intermediate molecular markers including estrogen receptor alpha (ER alpha) and ER beta differ between women supplemented with soy vs placebo. OUTLINE: Patients are randomized to 1 of 2 treatment arms.ARM I: Patients receive oral soy isoflavones supplement once daily for12 months in the absence of disease progression.ARM II: Patients receive oral placebo once daily for 12 months in the absence of disease progression.

Eligibility criteria: Inclusion Criteria:

* Women at high risk for breast cancer, defined as any of the following groups:
* Five year Gail risk \> 1.7%
* Known BRCA1/BRCA2 mutation carrier
* Family history consistent with hereditary breast cancer
* Prior biopsy exhibiting atypical hyperplasia or lobular carcinoma in situ (LCIS)
* History of invasive breast cancer or ductal carcinoma in situ (DCIS) and have completed standard therapy including tamoxifen/aromatase inhibitor or will not be treated with tamoxifen/aromatase inhibitor
* Signed Informed Consent

Exclusion Criteria:

* Metastatic breast cancer
* Undergoing treatment (chemotherapy, radiation, or SERMs)
* Pregnancy or breast-feeding, or planning to become pregnant within one year prior to study entry
* Regular soy consumers (i.e., \< once per week of soy food, soy supplements or other products)
* Known food allergies such as to soy or nuts
* Not willing to avoid soy foods/supplements during study period
* Current users of exogenous hormones or oral contraceptive or planning to use exogenous hormones during the duration of the study
* Cannot stop taking aspirin or NSAIDs within a week of breast biopsy
* Active participant in other ongoing trials

Primary outcomes:
measure: Number of participants with reduced MRI volume (MRIV)
timeFrame: At completion of 12 months on the study
Secondary outcomes:
measure: Percentage of cells that stain positive for Ki67, caspase 3, ratio of Ki67/caspase, ER alpha and ER beta
timeFrame: At completion of 12 months on the study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Anna Wu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu AH, Spicer D, Garcia A, Tseng CC, Hovanessian-Larsen L, Sheth P, Martin SE, Hawes D, Russell C, MacDonald H, Tripathy D, Su MY, Ursin G, Pike MC. Double-Blind Randomized 12-Month Soy Intervention Had No Effects on Breast MRI Fibroglandular Tissue Density or Mammographic Density. Cancer Prev Res (Phila). 2015 Oct;8(10):942-51. doi: 10.1158/1940-6207.CAPR-15-0125. Epub 2015 Aug 14.