Afimoxifene Gel for Breast Cancer

Phase 2

Recruiting

Led By Seema A Khan, M.D.

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%).

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 35 days pot-treatment

Awards & highlights

Study Summary

This trial looks at how well a medicated gel works at treating breast cancer in patients who have had radiation therapy on one breast.

Who is the study for?

This trial is for women who've had radiation therapy on one breast due to breast cancer and are not currently pregnant or nursing. They must have completed any cancer treatments, avoid sun exposure during the study, and use two forms of birth control. Men, those with skin lesions on the breast, a history of blood clots or allergic reactions to similar drugs are excluded.Check my eligibility

What is being tested?

The trial is testing topical Afimoxifene gel's effectiveness in blocking breast cancer cell growth when applied to the skin of a previously radiated breast. It also examines how different skin types and prior radiation affect drug delivery into the tissue.See study design

What are the potential side effects?

While specific side effects for topical Afimoxifene aren't detailed here, related compounds can cause symptoms like hot flashes, vaginal dryness or discharge, nausea, leg cramps, and an increased risk of blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly active and can carry out light work.

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I agree to use two effective birth control methods during and for two months after the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 35 days pot-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 35 days pot-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 35 days pot-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determinants of inter-individual variation in afimoxifene drug concentrations in unradiated breast tissue related to skin features

Determinants of inter-individual variation in afimoxifene drug concentrations in unradiated breast tissue related to skin histology, blood and lymph vessel density

Determinants of inter-individual variation in afimoxifene drug concentrations in unradiated breast tissue related to the expression of xenobiotic transporters and enzymes

Secondary outcome measures

Differences between radiated and non-radiated skin and breast tissue that contribute to differences in permeation

Effect of breast radiotherapy on drug concentrations resulting from transdermal delivery of afimoxifene (4-OHT)