Topical Afimoxifene in Treating Patients With Breast Cancer Who Have Undergone Radiation Therapy on One Breast
NCT04009044 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156
Last updated 2025-10-09
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.
Conditions
- Cancer Survivor
- Ductal Breast Carcinoma In Situ
- Invasive Breast Carcinoma
Interventions
- DRUG
-
Afimoxifene
Apply topically
- PROCEDURE
-
Core Biopsy
Undergo core needle biopsy
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Seema A Khan, M.D. · Northwestern University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-02-17
- Primary Completion
- 2026-01-31
- Completion
- 2026-06-25
- FDA Drug
- Yes
Countries
- United States
Study Locations
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