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

Cancer Survivor Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04009044
Study type Interventional
Source Northwestern University
Contact Study Coordinator
Phone (312)695-1301
Email cancertrials@northwestern.edu
Status Recruiting
Phase Phase 2
Start date February 17, 2020
Completion date June 25, 2024
View Details
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