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

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.

Timeline

Start

2011-01

Primary completion

2017-07

Completion

2017-07

Outcome

Missed primary endpoint

Stopped (Enrollment): “accrual rate lower than anticipated; funding expired”

registry analysis (superiority test); Flaxseed Lignan, SDG vs Placebo; p = 0.72; Wilcoxon (Mann-Whitney); note: a priori threshold for statistical significance: \< 0.05 NCT01276704 ↗

paper with no significant difference between arms. PMID 32312713 ↗

Publications

• Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	secoisolariciresinol diglucoside	Small molecule	50 mg	—

Indications