NCT03199963

Trial of 4-Hydroxytamoxifen (4-OHT) Gel in Women Aimed at Reducing Dense Breast Tissue

A Randomized, Double-blind, Placebo Controlled Trial of 4-Hydroxytamoxifen Gel for Reducing Breast Tissue Density in Women With BI-RADS Breast Density Categories C or D

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: BHR Pharma, LLC · Industry
• Sex: Female
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A study to determine the efficacy of 8 mg/day (4 mg/breast) of BHR-700 gel compared to placebo for reducing breast tissue density in women identified as having dense breast tissue upon analysis of screening mammography. The Primary Study Endpoint being the percent reduction of mammographic breast tissue density on a follow-up mammogram compared to the baseline mammogram after 52 weeks of treatment.

Detailed description

This is a randomized, double blind, placebo-controlled study. Subjects will have been assessed as having mammographically dense breast (heterogeneously dense (C) or extremely dense (D), based on the American College of Radiology (ACR) Breast Imaging-Reporting and Data System (BIRADS©) fifth edition classification) for eligibility. Approximately 330 subjects will be enrolled at approximately 25 sites in the US and the European Union. Subjects who give informed consent will be stratified, based on whether they are pre/peri or post-menopausal and randomized 2:1 within those groups to receive either 8 mg/day (4 mg/breast) 4-OHT or matching placebo for up to 52 weeks. Subjects will apply the investigational gel to both breasts once per day until they have completed 52 weeks of study drug administration. There will be, in addition, an optional 52 weeks of open-label treatment for those subjects who choose to continue treatment. Subjects will capture daily gel administration in a diary to monitor compliance. While on treatment, subjects will return to the clinic for study assessments, a review of adverse events (AEs) and to re-supply study gel at 13, 26, 39, weeks and at 52 weeks for those subjects who have agreed to take part in the open-label phase of the study. During the study, in a case of significant changes in bleeding pattern or other signs/symptoms which could be related to endometrial pathology, the Investigator will perform a uterine ultrasound followed by an endometrial biopsy if indicated. Open-Label Treatment Phase Secondary Outcome Measures: • Comparison of breast density measurements (Cumulus and Volpara) • Laboratory parameters will be summarized in a descriptive fashion. • Incidence and severity of AEs will be compared between BHR-700 gel and placebo.

Conditions

• Mammographic Breast Density

Interventions

Type	Name	Description
DRUG	4-OH tamoxifen	4-Hydroxytamoxifen (afimoxifene) gel
DRUG	Placebo	An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.

Timeline

• Start date: 2017-08-21
• Primary completion: 2019-01-14
• Completion: 2019-04-23
• First posted: 2017-06-27
• Last updated: 2022-07-26
• Results posted: 2021-11-17

Locations

19 sites across 3 countries: United States, Germany, Spain

Regulatory

• FDA-regulated drug study