Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Placebo; Drug: secoisolariciresinol

• Registration Number: NCT01276704
• Lead Sponsor: Carol Fabian, MD

Brief Summary

The investigators will study the effect of 12 months of SDG (Brevail) vs placebo on women at increased risk for development of breast cancer.

Detailed Description

The investigators would like to see if women at increased risk for breast cancer are likely to tolerate SDG daily for 12 months without significant side effects or changes in their menstrual cycles. The investigators would also like to determine if Brevail® can reduce breast cell proliferation in pre-menopausal women.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2023-08
• Results First Submitted: 2023-08-01
• Results First Submitted QC: 2023-08-29
• Last Update Submitted: 2023-08-29
• Results First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matched Placebo
flaxseed lignan, SDG	secoisolariciresinol	Secoisolariciresinol diglycoside

Primary Outcome Measures

Name	Time	Method
Change in Percent of Breast Epithelial Cells With Ki-67 Immunocytochemical Expression	12 months	Change over the course of study in the percent of breast epithelial cells expressing the proliferation marker Ki- 67/MIB-1 in hyperplastic benign breast tissue acquired by random periareolar fine needle aspiration pre-study and post-study.

Secondary Outcome Measures

Name	Time	Method
Breast Cancer Prevention Trial (BCPT) Symptom Checklist	12 months	Quality of life as measured by the Breast Cancer Prevention Trial (BCPT) Symptom Checklist, completed at baseline and end of study by each participant.; Responses to 43 questions (with each question given a value from 0 to 4, higher score being worse) are clustered into seven domains to yield an average score per domain. These seven category scores are then averaged to provide a final average score (range by definition, 0 to 4). Change in score over the course of the intervention per individual is then assessed. By definition, change in score theoretically ranges from -4 to +4.
Change in Gene Expression	12 months	Gene expression in breast epithelial cells assessed by RT-qPCR. Change in expression (fold-change for 12-months compared to baseline value) was evaluated by cluster analysis and used to define "responders" and non-responders" based on favorable or non-favorable modulation of a set of 12 relevant genes.; Specifically, data for change in ESR1 (codes for estrogen receptor alpha) are shown.

Trial Locations

Locations (7)

Northwestern University Medical Center; 🇺🇸 Chicago, Illinois, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Ohio State Unviersity Medical Center; 🇺🇸 Columbus, Ohio, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States