Afimoxifene Gel for Breast Cancer

Not currently recruiting at 1 trial location

Overseen By Study Coordinator

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Northwestern University

Must not be taking: SERMs

Disqualifiers: Uncontrolled hypertension, Active infection, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3-5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a medicated gel called afimoxifene for individuals with breast cancer who have undergone radiation therapy on one breast. The gel, applied to the skin, may block cancer cell growth. The study examines whether skin differences affect gel absorption and how radiation influences its delivery to breast tissue. Ideal participants have received radiation on one breast for ductal or invasive breast cancer, have an intact non-radiated breast, and can avoid sun exposure on their breast skin during the trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications. If you are currently using oral selective estrogen receptor modulators (SERMs) like tamoxifen, raloxifene, or bazedoxifene, you cannot participate in the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that afimoxifene gel is likely to be safe for humans?

Studies have shown that afimoxifene gel is generally safe and easy to use when applied to the skin. Research in France involving 55 women found that the gel was as effective as tamoxifen tablets in slowing breast cancer growth. Importantly, that study noted that patients responded well to the gel, with no major safety issues reported.

Researchers have also studied afimoxifene for other conditions, such as breast pain related to menstrual cycles and fibrocystic breast disease, a non-cancerous condition where the breasts feel lumpy. These studies have expanded understanding of its use and safety in people.

Since this trial is in an early stage, it aims to collect more detailed information on safety and effectiveness. Previous studies suggest it is safe, but further research will provide clearer answers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for breast cancer, which often involve systemic therapies like oral medications or intravenous chemotherapy, afimoxifene is applied topically as a gel directly to the breasts. This unique delivery method allows the active ingredient, afimoxifene, a selective estrogen receptor modulator (SERM), to be absorbed locally, potentially reducing systemic side effects. Researchers are excited about afimoxifene because it offers a targeted approach that could minimize the impact on the rest of the body while effectively addressing cancer cells in the breast tissue. This could make treatment more tolerable for patients while maintaining efficacy.

What evidence suggests that afimoxifene gel might be an effective treatment for breast cancer?

Research has shown that afimoxifene gel, containing a form of tamoxifen, has potential in treating breast cancer. In earlier studies, daily use of this gel significantly improved breast symptoms after a few months. Afimoxifene helps manage breast pain and might also reduce the risk of developing breast cancer by stopping cancer cells in the breast from growing. In this trial, participants will apply afimoxifene gel topically to both breasts for 3 to 5 weeks. These findings suggest that afimoxifene gel could be a helpful treatment option for breast cancer patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Seema A Khan, M.D.

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply afimoxifene gel topically once daily to both breasts for 3 to 5 weeks and then undergo core needle biopsies of both breasts

3-5 weeks

Follow-up

Participants receive a follow-up phone call to monitor safety and effectiveness after treatment

3-5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Afimoxifene
• Core Biopsy

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.

How Is the Trial Designed?

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17351746/

A phase II trial of Afimoxifene (4-hydroxytamoxifen gel) for ... After 4 months of treatment, daily topical breast application of Afimoxifene resulted in statistically significant improvements in signs and symptoms of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03063619?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(4-OHT))&rank=2

Study Details | Afimoxifene in Reducing the Risk of Breast ... This randomized phase II trial studies how well afimoxifene works in reducing the risk of breast cancer in women with mammographically dense breast.

3. ascopubs.org ascopubs.org/doi/10.1200/jco.2009.27.15_suppl.e14598

Plasma levels of 4-OHT with topical tamoxifen gel ... Afimoxifene is an effective treatment for moderate-to-severe mastalgia and potentially may be used for breast cancer chemoprevention and gynecomastia. No ...

4. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2017-0328.html

A Randomized, Double-blind, Placebo-Controlled Study of 4 This randomized phase II trial studies how well afimoxifene works in reducing the risk of breast cancer in women with mammographically dense breast.

5. trial.medpath.com trial.medpath.com/clinical-trial/de3cadfb1c2641ee/testing-tamoxifen-ductal-carcinoma

Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered ... This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating patients with estrogen receptor positive breast cancer.

6. medkoo.com medkoo.com/products/5190

Afimoxifene | CAS#68392-35-8 A study in France on 55 women showed that rubbing afimoxifene on the skin was as good as tamoxifen tablets at slowing breast cancer growth. ... Safety Data Sheet ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03063619

NCT03063619 | Afimoxifene in Reducing the Risk of Breast ... This randomized phase II trial studies how well afimoxifene works in reducing the risk of breast cancer in women with mammographically dense breast.

8. go.drugbank.com go.drugbank.com/drugs/DB04468

Afimoxifene: Uses, Interactions, Mechanism of Action For the potential treatment of menstrual-cycle related mastalgia, fibrocystic breast disease, breast disease, gynecomastia and Keloid scarring.

9. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/4-Hydroxytamoxifen

4-Hydroxytamoxifen | C26H29NO2 | CID 449459 - PubChem Afimoxifene (4-Hydroxytamoxifen, trade name TamoGel) is a new estrogen inhibitor under investigation for a variety of estrogen-dependent conditions.

10. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCT02993159

Tamoxifen Citrate or Afimoxifene in Treating Patients with ... This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating patients with estrogen receptor positive breast cancer.