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



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - 49
Updated:1/19/2018
Start Date:January 2011
End Date:July 2017

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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.

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.

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.
We found this trial at
7
sites
Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Larissa A Korde, MD MPH
Phone: 206-288-6329
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Suzanne Klimberg, MD
Phone: 501-526-6990
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Judy E Garber, MD
Phone: 617-582-7107
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Chicago, Illinois 60611
Principal Investigator: Seema A Khan, MD
Phone: 312-472-4767
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Chicago, IL
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Columbus, Ohio 43210
Principal Investigator: Lisa D Yee, MD
Phone: 614-519-8995
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Columbus, OH
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Carol Fabian, MD
Phone: 913-588-3622
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: William C Dooley, MD
Phone: 405-271-8770
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Oklahoma City, OK
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