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Selective Estrogen Receptor Modulator

Endoxifen for Breast Cancer

Phase 1

Waitlist Available

Led By Seema A Khan

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Ability to understand and the willingness to sign a written informed consent document which includes a requirement to apply study agent to sensitive body parts daily

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

Must not have

Endometrial intraepithelial neoplasia (also known as atypical hyperplasia) or a high risk of uterine cancer, defined here as known carriers of Lynch syndrome mutations (MLH1, MSH2, MSH6, PMS2)

Women with skin diseases (psoriasis, eczema)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 days

Summary

This trial is testing the side effects and best dose of a drug called endoxifen hydrochloride in people who are having breast surgery. Endoxifen hydrochloride may help treat or prevent breast cancer.

Who is the study for?

This trial is for women over 18 with confirmed stage 0-III breast cancer or high risk of breast cancer, who are scheduled for mastectomy. They must have normal organ function and agree to use birth control. Excluded are those with recent breast cancer therapy, skin diseases, a history of blood clots or uterine cancer risks, current users of topical medications on the breasts (unless willing to stop), and pregnant or breastfeeding women.

What is being tested?

The trial is testing Endoxifen Hydrochloride gel applied to the breast versus a placebo in patients awaiting surgery. The aim is to determine the best dose and side effects of this potential treatment that may reduce the risk or treat breast cancer.

What are the potential side effects?

While specific side effects aren't listed here, similar treatments often cause skin irritation at the application site. There could also be systemic effects due to absorption such as hot flashes, mood swings, vaginal dryness or discharge which are common with estrogen-targeting drugs.

Eligibility Criteria

Inclusion Criteria

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

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I can understand and am willing to sign consent to apply a study treatment daily.

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I am mostly active and can care for myself.

Exclusion Criteria

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

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I have a high risk of uterine cancer or a condition leading to it.

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I am a woman with a skin condition like psoriasis or eczema.

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I have had a mastectomy in the past.

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I am a woman who had a 'nipple delay' procedure before my mastectomy.

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I have taken tamoxifen or similar drugs in the last 2 years or stopped due to side effects.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I have a history of blood clots.

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I am not a man, as this study excludes men.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants With Dermal Toxicity on Breast Skin at the Application Site

Secondary study objectives

Change in Plasma Estrogenic and Coagulation Parameters

Change in Pre-therapy and Post-therapy Symptoms Captured by BESS Questionnaire

Drug Concentration in Plasma

+1 more

Other study objectives

Tissue biologic response

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort I (endoxifen hydrochloride)Experimental Treatment2 Interventions

Participants apply endoxifen hydrochloride gel to both breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery.

Group II: Cohort II (placebo)Placebo Group2 Interventions

Participants apply placebo to both breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery.

0 / 10Eligibility criteria met