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

NCT01276704 | Terminated Phase 2 Results DMC

• 1 other identifier: 12377
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Percent of Breast Epithelial Cells With Ki-67 Immunocytochemical Expression

  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 Outcomes (2)

• Change in Gene Expression

  12 months

• Breast Cancer Prevention Trial (BCPT) Symptom Checklist

  12 months

Study Arms (2)

flaxseed lignan, SDG

EXPERIMENTAL

Secoisolariciresinol diglycoside

Drug: secoisolariciresinol

Placebo

PLACEBO COMPARATOR

Matched Placebo

Drug: Placebo

Interventions

Placebo DRUG

The placebo contains same filler materials as commercially available Brevail® but without active SDG.

Placebo

secoisolariciresinol DRUG

1 capsule daily of secoisolariciresinol diglycoside (SDG)50mg

Also known as: SDG

flaxseed lignan, SDG

Eligibility Criteria

• Age: 21 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Carol Fabian, MD: lead
• Lignan Research Inc.: collaborator

Study Sites (7)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Northwestern University Medical Center

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Ohio State Unviersity Medical Center

Columbus, Ohio, 43210, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Washington

Seattle, Washington, 98109-1023, United States

Location

Related Publications (1)

• Fabian CJ, Khan SA, Garber JE, Dooley WC, Yee LD, Klemp JR, Nydegger JL, Powers KR, Kreutzjans AL, Zalles CM, Metheny T, Phillips TA, Hu J, Koestler DC, Chalise P, Yellapu NK, Jernigan C, Petroff BK, Hursting SD, Kimler BF. Randomized Phase IIB Trial of the Lignan Secoisolariciresinol Diglucoside in Premenopausal Women at Increased Risk for Development of Breast Cancer. Cancer Prev Res (Phila). 2020 Jul;13(7):623-634. doi: 10.1158/1940-6207.CAPR-20-0050. Epub 2020 Apr 20.

  PMID: 32312713 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

secoisolariciresinol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Early termination led to small numbers of subjects analyzed. A total of 240 enrollees was planned; actual accrual was 180.

Results Point of Contact

• Title: Bruce F. Kimler, Ph.D.
• Organization: University of Kansas Medical Center

bkimler@kumc.edu

913-205-6382

Study Officials

• Carol Fabian, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Director Breast Cancer Prevention Unit

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 13, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)