Overview

This trial is active, not recruiting.

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
Treatments soy isoflavones, placebo, questionnaire administration, magnetic resonance imaging, biopsy, immunohistochemistry staining method, laboratory biomarker analysis, mammography
Sponsor University of Southern California
Collaborator National Cancer Institute (NCI)
Start date June 2010
End date December 2014
Trial size 110 participants
Trial identifier NCT01219075, 1B-10-6, NCI-2010-01847

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.
soy isoflavones NovaSoy
Given orally
questionnaire administration
Ancillary studies
magnetic resonance imaging MRI
Correlative studies
biopsy biopsies
Correlative studies
immunohistochemistry staining method immunohistochemistry
Correlative studies
laboratory biomarker analysis
Correlative studies
mammography
Correlative studies
(Placebo Comparator)
Patients receive oral placebo once daily for 12 months in the absence of disease progression.
placebo PLCB
Given orally
questionnaire administration
Ancillary studies
magnetic resonance imaging MRI
Correlative studies
biopsy biopsies
Correlative studies
immunohistochemistry staining method immunohistochemistry
Correlative studies
laboratory biomarker analysis
Correlative studies
mammography
Correlative studies

Primary Outcomes

Measure
Number of participants with reduced MRI volume (MRIV)
time frame: 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
time frame: At completion of 12 months on the study

Eligibility Criteria

Female participants from 30 years up to 75 years old.

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

Additional Information

Official title Soy Treatment for High-risk Women
Principal investigator Anna Wu
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Southern California.