ACTIVE_NOT_RECRUITING

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

Conditions

Cancer Survivor Ductal Breast Carcinoma In Situ Invasive Breast Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-02-17

Study Completion:2026-06-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04009044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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).

Inclusion Criteria

Exclusion 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.

* 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).

Contacts and Locations

Principal Investigator

Seema A Khan, M.D.

PRINCIPAL_INVESTIGATOR

Northwestern University

Study Locations (Sites)

Northwestern University

Chicago, Illinois, 60611

United States

University of Illinois Cancer Center

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: Northwestern University

Seema A Khan, M.D., PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-17

Study Completion Date2026-06-25

Study Record Updates

Study Start Date2020-02-17

Study Completion Date2026-06-25

Terms related to this study

Additional Relevant MeSH Terms

Cancer Survivor
Ductal Breast Carcinoma In Situ
Invasive Breast Carcinoma