Afimoxifene Gel for Breast Cancer

Recruiting at1 trial location

Overseen by Seema A Khan, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Northwestern University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial studies how well a medicated gel called afimoxifene works for breast cancer patients who have had radiation therapy. The gel is applied to the skin and may help stop cancer cells from growing by reaching the breast tissue. Afimoxifene is a transdermal form of tamoxifen, which has been used for decades in the treatment and prevention of breast cancer.

Research Team

Seema A Khan, M.D.

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Inclusion Criteria

Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

FOCBP must have a negative urine pregnancy test within 7 days prior to registration on study.

I agree not to expose my breast skin to sunlight or use tanning beds while on the study drug.

Exclusion Criteria

I do not have any uncontrolled illnesses.

I have never had endometrial cancer.

I am not pregnant or nursing.

Treatment Details

Interventions

• Afimoxifene (Selective Estrogen Receptor Modulator)
• Core Biopsy (Procedure)

Trial Overview 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.

Participant Groups

Group I: Treatment (afimoxifene) Experimental Treatment 3 Interventions

Patients apply afimoxifene gel topically QD to both breasts for 3 to 5 weeks and then undergo core needle biopsies of both breasts.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School