Can a gel fight breast cancer? new study tests skin absorption after radiation
NCT ID NCT04009044
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how well a medicated gel (afimoxifene) is absorbed through the skin of the breast in women who have had radiation for breast cancer. Researchers want to understand if differences in skin type or past radiation change how much gel gets into the breast tissue. The goal is to learn how to best use this gel to possibly prevent or treat breast cancer in the future. About 156 women who had radiation on one breast will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 156 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2020
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have received prior unilateral breast radiotherapy (RT) for ductal breast carcinoma in situ (DCIS) or invasive cancer (\>= 12 weeks after the end of RT), and have an intact unradiated (non-RT) breast. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%). * A prior history of malignancy is allowed, as long as the patient is considered to have ?no evaluable disease? and cancer treatment has been completed. * Females of child-bearing potential (FOCBP) and male partners of female participants must agree to use TWO effective forms of birth control (abstinence is not an allowed method) prior to study entry and for the duration of study participation, and for two months following the last dose of study medications. Effective birth control methods are: copper IUD (intrauterine device), diaphragm/cervical cap/shield, spermicide, contraceptive sponge, condoms. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months). * FOCBP must have a negative urine pregnancy test within 7 days prior to registration on study. * Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of the study drug use. * Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study. Exclusion Criteria: * Patients receiving any other investigational agents within 30 days of registration are not eligible. * Patients currently using oral selective estrogen receptor modulators (SERMS) (tamoxifen, raloxifene, bazedoxifene) are not eligible. * Note: Prior or current endocrine therapy other than SERMs are allowed. * Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition afimoxifene (4-OHT) are not eligible. * Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible: * Hypertension that is not controlled on medication * Ongoing or active infection requiring systemic treatment * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient?s safety or study endpoints. * Female patients who are pregnant or nursing are not eligible. * Patients with prior bilateral breast cancer radiotherapy or radiotherapy for lymphoma will be excluded. * Patients with skin lesions on the breast that disrupt the stratum corneum (e.g. eczema, ulceration) are not eligible. * Patients with a history of endometrial neoplasia are not eligible. * Patients with a history of thromboembolic disease are not eligible. * Note: history of varicose veins and superficial phlebitis is allowed. * Patients who are undergoing active treatment for any malignancy will be excluded. * Male patients are excluded from this study since there are no data regarding skin penetration of 4-OHT though male chest wall skin (which is thicker and hairier than female chest wall skin).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Northwestern University
Chicago, Illinois, 60611, United States
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University of Illinois Cancer Center
Chicago, Illinois, 60612, United States
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Other studies related to the condition(s) this trial covers.
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