Clinical Trials /

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

NCT01276704

Description:

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

Related Conditions:
  • Breast Fibrocystic Change, Proliferative Type
  • Breast Intraductal Proliferative Lesion
  • Breast Lobular Carcinoma In Situ
  • Hereditary Breast and Ovarian Cancer Syndrome
  • Intraductal Proliferative Lesion of the Breast
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Prevention Strategy for Pre-Menopausal Women at High Risk for Development of <span class="go-doc-concept go-doc-disease">Breast Cancer</span>

Title

  • Brief Title: Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer
  • Official Title: Flaxseed Lignan as a Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer
  • Clinical Trial IDs

    NCT ID: NCT01276704

    ORG ID: 12377

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Placebo Placebo
    secoisolariciresinol SDG flaxseed lignan, SDG

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    flaxseed lignan, SDG Experimental Secoisolariciresinol diglycoside secoisolariciresinol
    Placebo Placebo Comparator Matched Placebo Placebo

    Eligibility Criteria

    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 [104].

    - 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, acolbifine, 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.

    Minimum Eligible Age: 21 Years

    Maximum Eligible Age: 49 Years

    Eligible Gender: Female

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    to determine if 12 months of SDG is associated with favorable modulation of other risk biomarkers

    to determine if Ki-67 and modulation of other risk biomarkers is correlated with related to change in blood or urine lignans

    to determine impact or potential impact on quality of life

    Trial Keywords