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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01276704
Recruitment Status : Completed
First Posted : January 13, 2011
Last Update Posted : January 17, 2018
Lignan Research Inc.
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Placebo Drug: secoisolariciresinol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Flaxseed Lignan as a Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer
Actual Study Start Date : January 2011
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: flaxseed lignan, SDG
Secoisolariciresinol diglycoside
Drug: secoisolariciresinol
1 capsule daily of secoisolariciresinol diglycoside (SDG)50mg
Other Name: SDG

Placebo Comparator: Placebo
Matched Placebo
Drug: Placebo
The placebo contains same filler materials as commercially available Brevail® but without active SDG.

Primary Outcome Measures :
  1. The primary objective is to determine if women randomized to 12 months of SDG exhibit greater change in the proportion of breast epithelial cells expressing benign breast tissue than do women randomized to placebo. [ Time Frame: 12 months ]
    The primary objective is to determine if women randomized to 12 months of SDG exhibit greater change in the proportion of breast epithelial cells expressing the proliferation marker Ki- 67/MIB-1 in hyperplastic benign breast tissue than do women randomized to placebo.

Secondary Outcome Measures :
  1. to determine if 12 months of SDG is associated with favorable modulation of other risk biomarkers [ Time Frame: 12 months ]
    Other biomarkers will be assessed so as to provide explanation for the observed responses.

  2. to determine if Ki-67 and modulation of other risk biomarkers is correlated with related to change in blood or urine lignans [ Time Frame: 6 months and 12 months ]
    Biomarker modulation will be correlated to blood lignan levels achieved.

  3. to determine impact or potential impact on quality of life [ Time Frame: 12 months ]
    to determine impact or potential impact on quality of life as measured by the BPQ breast pain questionnaire (a modified McGill Pain questionnaire), The Breast Cancer Prevention Trial (BCPT) Symptom Checklist a menstrual diary for cyclicity and cycle length and antimullerian hormone (AMH), a measure of follicular reserve

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01276704

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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Illinois
Northwestern University Medical Center
Chicago, Illinois, United States, 60611
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Ohio
Ohio State Unviersity Medical Center
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Washington
University of Washington
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Carol Fabian, MD
Lignan Research Inc.
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Principal Investigator: Carol Fabian, MD University of Kansas Medical Center
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Responsible Party: Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center Identifier: NCT01276704    
Other Study ID Numbers: 12377
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Global results will be published.
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs