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

NCT01219075 | Completed

• 2 other identifiers: 1B-10-6NCI-2010-01847
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with reduced MRI volume (MRIV)

  At completion of 12 months on the study

Secondary Outcomes (1)

• Percentage of cells that stain positive for Ki67, caspase 3, ratio of Ki67/caspase, ER alpha and ER beta

  At completion of 12 months on the study

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.

Dietary Supplement: soy isoflavones; Other: questionnaire administration; Procedure: magnetic resonance imaging; Procedure: biopsy; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: mammography

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo once daily for 12 months in the absence of disease progression.

Other: placebo; Other: questionnaire administration; Procedure: magnetic resonance imaging; Procedure: biopsy; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: mammography

Interventions

soy isoflavones DIETARY_SUPPLEMENT

Given orally

Also known as: NovaSoy, soy phytoestrogens

Arm I

placebo OTHER

Given orally

Also known as: PLCB

Arm II

questionnaire administration OTHER

Ancillary studies

Arm I; Arm II

magnetic resonance imaging PROCEDURE

Correlative studies

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Arm I; Arm II

biopsy PROCEDURE

Correlative studies

Also known as: biopsies

Arm I; Arm II

immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Arm I; Arm II

laboratory biomarker analysis OTHER

Correlative studies

Arm I; Arm II

mammography PROCEDURE

Correlative studies

Arm I; Arm II

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator
• California Breast Cancer Research Program: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90033-0804, United States

Location

Related Publications (1)

• 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.

  PMID: 26276750 DERIVED

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ; Breast Neoplasms

Interventions

Soybean Proteins; Magnetic Resonance Spectroscopy; Biopsy; Immunohistochemistry

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Histocytochemistry; Histological Techniques; Immunologic Techniques

Study Officials

• Anna Wu

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 13, 2010
• Study Start: July 1, 2010
• Primary Completion: November 24, 2022
• Study Completion: November 24, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)