Study on Topical Afimoxifene for Breast Cancer Patients Who Have Had Radiation on One Breast
Sponsor: Northwestern University
ClinicalTrials ID:NCT04009044
This clinical trial is testing a medicated gel called afimoxifene to see if it can help treat breast cancer in patients who have had radiation therapy on one breast. The study aims to understand how different skin types affect the gel's delivery to breast tissue and whether radiation impacts its effectiveness.
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Program Overview
This study is exploring how well a medicated gel called afimoxifene works in treating breast cancer in patients who have had radiation therapy on one breast. Afimoxifene is a gel that dries quickly and may help stop the growth of breast cancer cells when applied to the skin. The research aims to find out if differences in skin type affect how the gel is absorbed into breast tissue and if radiation changes how the gel works.
Description
The main goal of this study is to identify skin features that cause differences in how the drug penetrates the skin among different people. Researchers also want to see how the drug concentration in breast tissue relates to skin characteristics like histology, blood vessels, and proteins, as well as features seen under a special microscope. Another goal is to see if the gel can be effectively delivered to the breast that has received radiation.
Participants will apply the afimoxifene gel to both breasts once a day for four weeks. After this period, they will have a core needle biopsy of both breasts to collect tissue samples. A follow-up phone call will be made 21-35 days after the biopsy to check on the participants.
Eligibility Criteria
Inclusion Criteria
- Must have had radiation therapy on one breast for ductal breast carcinoma in situ (DCIS) or invasive cancer, at least 12 weeks ago, and have an intact breast that did not receive radiation.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- A history of cancer is allowed if the patient has no active disease and has completed treatment.
- Women of childbearing potential and their male partners must use two effective forms of birth control during the study and for two months after the last dose. Abstinence is not allowed.
- Women must have a negative pregnancy test within seven days before starting the study.
- Must avoid exposing breast skin to sunlight or tanning beds during the study.
- Must be able to understand and sign a written informed consent before joining the study.
Exclusion Criteria
- Cannot be using any other investigational drugs within 30 days before joining the study.
- Cannot be using oral selective estrogen receptor modulators (SERMs) like tamoxifen, raloxifene, or bazedoxifene.
- Cannot have a history of allergic reactions to similar compounds as afimoxifene.
- Cannot have uncontrolled health issues like high blood pressure, active infections, heart failure, unstable chest pain, irregular heartbeats, or psychiatric conditions that would affect study participation.
- Cannot be pregnant or breastfeeding.
- Cannot have had radiation therapy on both breasts or for lymphoma.
- Cannot have skin conditions on the breast that disrupt the outer skin layer, like eczema or ulcers.
- Cannot have a history of endometrial cancer or blood clotting disorders, except for varicose veins or superficial phlebitis.
- Cannot be undergoing active treatment for any cancer.
- Male patients are not eligible for this study.
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