Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer

NCT01219075 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-11-18

No results posted yet for this study

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.

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

Interventions

DIETARY_SUPPLEMENT

soy isoflavones

Given orally

OTHER

placebo

Given orally

OTHER

questionnaire administration

Ancillary studies

PROCEDURE

magnetic resonance imaging

Correlative studies

PROCEDURE

biopsy

Correlative studies

OTHER

immunohistochemistry staining method

Correlative studies

OTHER

laboratory biomarker analysis

Correlative studies

PROCEDURE

mammography

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • California Breast Cancer Research Program

    collaborator OTHER
  • University of Southern California

    lead OTHER

Principal Investigators

  • Anna Wu · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-01
Primary Completion
2022-11-24
Completion
2022-11-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01219075 on ClinicalTrials.gov