Using topical afimoxifene to treat breast cancer after radiation therapy

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

This study is testing if a special gel can help treat breast cancer in patients who have already had radiation therapy, while also looking at how different skin types and radiation affect how well the gel works.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Northwestern University (other)
• Drugs / interventions: radiation
• Locations: 2 sites (Chicago, Illinois and 1 other locations)
• Trial ID: NCT04009044 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the effectiveness of topical afimoxifene, a medicated gel, in treating breast cancer patients who have previously undergone radiation therapy on one breast. The study aims to understand how different skin types affect the delivery of the medication to breast tissue and whether radiation impacts this delivery. Participants will apply the gel daily for four weeks and undergo core needle biopsies to assess drug concentration in breast tissue. Follow-up will occur via phone calls after the biopsy.

Who should consider this trial

Good fit: Ideal candidates are females who have received unilateral breast radiation therapy for ductal breast carcinoma in situ or invasive cancer and have an intact non-radiated breast.

Not a fit: Patients who have not undergone radiation therapy or those with active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new topical option for breast cancer survivors to manage their condition post-radiation therapy.

How similar studies have performed: While the approach of using topical treatments for breast cancer is not widely tested, similar studies have shown promise in localized treatments for other cancers.

Eligibility criteria

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).

Where this trial is running

Chicago, Illinois and 1 other locations

• Northwestern University — Chicago, Illinois, United States (RECRUITING)
• University of Illinois Cancer Center — Chicago, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Seema A Khan, M.D. — Northwestern University
• Study coordinator: Study Coordinator

Conditions: Cancer Survivor, Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma