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

August 29, 2023 updated by: Carol Fabian, MD

Flaxseed Lignan as a Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer

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

Study Overview

Status

Terminated

Conditions

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 Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State Unviersity Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Description

PARTICIPANT SELECTION

  • Risk Level Required for RPFNA Screening for Eligibility

    • Given the low probability of side effects and the desire to be able to generalize results to a moderate as well as high risk population, the target cohort is pre-menopausal women who have a relative risk for breast cancer which is 2-fold or greater than that of the average woman in their age group by virtue of any one of the following conditions:
  • A 1st or 2nd degree relative with breast cancer diagnosed under the age of 60
  • A prior biopsy indicating proliferative breast disease, atypical hyperplasia, or LCIS
  • Multiple prior breast biopsies regardless of histology
  • 50% or higher estimated mammographic density on visual inspection
  • Prior or current RPFNA evidence of atypia
  • Known carrier of a BRCA1 or 2 mutation.

    • Age, Life-Style and Medical Eligibility Criteria for Tissue Screening

Candidates for tissue screening for this study are pre-menopausal women who meet the risk criteria above and all of the following demographic and medical criteria:

  • Age 21 to 49 (limiting the maximum age to 49 will reduce the possibility of reduction in Ki-67 due to entry into menopause transition during the study).
  • Stable hormonal status for the previous 6 months (has not stopped or started oral contraceptives, or experienced lactation or pregnancy) and willing to maintain same status while on study.
  • BMI < 40 kg/m2.
  • Has had at least 4 menstrual cycles in past year
  • If regularly undergoing screening mammography, must have been performed within 9 months prior to baseline RPFNA, and interpreted as not suspicious for breast cancer
  • Breast exam interpreted as normal (not suspicious for cancer).

    • Exclusion Criteria for Screening RPFNA and Study Participation

Candidates are ineligible for tissue screening if they meet any of the following conditions:

  • Consumption of systemic antibiotics during the 3 weeks prior to baseline RPFNA. Systemic antibiotics reduce intestinal bacteria and thus the ability to convert SECO to ENL.
  • Consumption of supplements containing SDG (flaxseed or sesame seed) during the 3 weeks prior to baseline RPFNA. ( Consumption of foods containing flaxseed or sesame seed are OK.)
  • Use of any selective estrogen receptor modulator or aromatase inhibitor (tamoxifen, raloxifene, arzoxifene, acolbifene, anastrozole, exemestane, letrozole) within the previous 6 months.
  • Currently enrolled on an interventional investigational study.
  • Bilateral breast implants.
  • Invasive breast cancer or other invasive cancer diagnosis within five years.
  • Metastatic malignancy of any kind.excluding Hodgkin's or non-Hodgkin's lymphoma.
  • Current anticoagulant use.
  • Consumption of coumadin, fish oil, or other anticoagulants during the 3 weeks prior to baseline RPFNA.
  • Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for RPFNA or the trial.

    • Inclusion Criteria for Study Entry
  • RPFNA performed in the follicular portion (day 1-10) of the menstrual cycle. Note that day 1 is defined as the first day of bleeding.
  • RPFNA specimen exhibits hyperplasia +/- atypia (Masood score of ≥13) with ≥500 cells on the cytology slide.
  • Ki-67 ≥2% positivity (≥500 cells).
  • Willing to continue without oral contraceptives throughout the duration of the study participation (12 months). Non-oral contraceptives are permissible. If heterosexually active, must be agreeable to use some non-hormonal form of contraception during the trial or husband or partner must have had a vasectomy. (Safety of SDG during pregnancy has not been documented).
  • Have reasonable organ function as documented by metabolic chemistry profile.
  • Willing to undergo a history and physical at baseline and 12 months and be contacted periodically by the trial coordinator during the 12 month study period.
  • Willing to have blood drawn at baseline and twelve months.
  • Able to understand and willing to provide informed consent for the RPFNA's and study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: flaxseed lignan, SDG
Secoisolariciresinol diglycoside
1 capsule daily of secoisolariciresinol diglycoside (SDG)50mg
Other Names:
  • SDG
Placebo Comparator: Placebo
Matched Placebo
The placebo contains same filler materials as commercially available Brevail® but without active SDG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Percent of Breast Epithelial Cells With Ki-67 Immunocytochemical Expression
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gene Expression
Time Frame: 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.

12 months
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
Time Frame: 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.

12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Carol Fabian, MD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 12, 2011

First Posted (Estimated)

January 13, 2011

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Global results will be published.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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