NCT04009044

Topical Afimoxifene in Treating Patients With Breast Cancer Who Have Undergone Radiation Therapy on One Breast

A Phase II Study of the Determinants of Transdermal Drug Delivery to the Normal and the Radiated Breast

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well topical afimoxifene works in treating patients with breast cancer who have undergone radiation therapy on one breast. Topical afimoxifene is a quick-drying medicated gel that may block the growth of breast cancer cells when applied to the breast skin. The purpose of this research is to determine what effect, if any, differences in skin type between women have on the delivery of topical afimoxifene to the breast tissue, and whether radiation affects the delivery of topical afimoxifene to breast tissue.

Detailed description

PRIMARY OBJECTIVES: I. To identify the skin features that drive inter-individual variation in dermal drug permeation between individuals. SECONDARY OBJECTIVES: I. To relate breast tissue drug concentration to skin histology, skin vascularity, skin transporter proteins, and skin features measured using confocal reflectance microscopy. II. To assess the feasibility of transdermal drug delivery to the radiated breast. OUTLINE: Patients apply afimoxifene gel topically once daily (QD) to both breasts for 4 weeks and then undergo core needle biopsies of both breasts. Patients receive follow up phone call 21-35 days after biopsy.

Conditions

• Cancer Survivor
• Ductal Breast Carcinoma In Situ
• Invasive Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Afimoxifene	Apply topically
PROCEDURE	Core Biopsy	Undergo core needle biopsy
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-02-17
• Primary completion: 2026-01-31
• Completion: 2026-06-25
• First posted: 2019-07-05
• Last updated: 2025-10-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study