What side effects are associated with this type of intervention?

Common treatments for cancer survivors that block the growth of breast cancer cells, such as tamoxifen and aromatase inhibitors, are associated with several side effects. Tamoxifen can cause hot flashes, disturbed sleep, vaginal dryness, decreased sexual desire, and musculoskeletal symptoms. Aromatase inhibitors may lead to loss of bone density, fractures, and cardiovascular risks. These side effects should be discussed with a healthcare provider to manage and mitigate their impact on quality of life.

What prior FDA approvals exist?

FDA approvals for treatments similar to topical afimoxifene, which blocks the growth of breast cancer cells, include hormone therapies such as tamoxifen and aromatase inhibitors like letrozole and anastrozole. These drugs are used to treat hormone receptor-positive breast cancer by inhibiting estrogen's effects, which can promote cancer cell growth. Additionally, other FDA-approved treatments for cancer survivors include systemic therapies like chemotherapy and immunotherapy, which target cancer cells through different mechanisms.

What other types of research exist?

Promising novel alternatives to Topical Afimoxifene for cancer survivors include: 1) Pexidartinib, a CSF1R inhibitor, which has shown long-term efficacy in treating tenosynovial giant cell tumors. 2) Emactuzumab, a monoclonal antibody targeting CSF1R, demonstrating durable responses in advanced TGCT. 3) Nilotinib and other tyrosine kinase inhibitors like sunitinib and sorafenib, which have shown disease stabilization in progressive cases. These agents represent potential options for cancer survivors seeking novel treatments in 2024.

← Back to Search

Selective Estrogen Receptor Modulator

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.

Must not have

Patients with a history of endometrial neoplasia are not eligible.

Female patients who are pregnant or nursing are not eligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 35 days pot-treatment

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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

Select...

I am mostly active and can carry out light work.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have never had endometrial cancer.

Select...

I am not pregnant or nursing.

Select...

My breast skin is healthy without eczema or open sores.

Select...

I have never had a blood clotting disorder.

Select...

I am not currently taking any medications like tamoxifen.

Select...

I am not currently receiving treatment for any cancer.

Select...

I am not eligible for this study because I am male.

Select...

I have not had radiotherapy for both breasts or lymphoma.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (afimoxifene)Experimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Afimoxifene

Not yet FDA approved

Core Biopsy

2013

N/A

~130

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cancer survivors include hormonal therapies, chemotherapy, and immunotherapy. Hormonal therapies, such as tamoxifen and afimoxifene, work by blocking hormone receptors or reducing hormone production, thereby inhibiting the growth of hormone-responsive cancer cells. Chemotherapy targets rapidly dividing cells, including cancer cells, by interfering with cell division and DNA replication. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Understanding these mechanisms is crucial for cancer survivors as it helps in selecting the most appropriate treatment, managing side effects, and improving overall outcomes. For instance, topical afimoxifene, which blocks the growth of breast cancer cells, offers a targeted approach with potentially fewer systemic side effects, making it a valuable option for long-term management.

Adjuvant therapy of primary breast cancer: a review of key findings from the 7th international conference, St. Gallen, February 2001.