Endoxifen for Estrogen Receptor-Positive Breast Cancer

Recruiting at2 trial locations

Overseen by Matthew P. Goetz

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and the best dose of Z-endoxifen hydrochloride in treating patients with estrogen receptor-positive (ER+) breast cancer that has spread to other places in the body (metastatic) or has come back at or near the same place as the original tumor (locally recurrent). Estrogen can cause the growth of breast cancer cells. Hormone therapy using Z-endoxifen hydrochloride may fight breast cancer by blocking the use of estrogen by tumor cells.

Research Team

Matthew P. Goetz

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for postmenopausal women with ER+ metastatic or locally recurrent breast cancer. Participants must have had prior hormone therapy, be able to swallow capsules, and have a life expectancy over 16 weeks. They should not have uncontrolled brain metastases, recent seizures, active blood clots, or other severe diseases that could interfere with the study.

Inclusion Criteria

I understand the study's risks and benefits and can give written consent.

I have had hormone therapy for cancer that has spread, using tamoxifen or an aromatase inhibitor.

Your platelet count is at least 75,000 per microliter of blood.

Exclusion Criteria

I started hormonal therapy less than 3 weeks ago.

I have not had any HER2-targeted therapy in the last 3 weeks.

I haven't received monoclonal antibodies in the last 3 weeks.

Treatment Details

Interventions

• Z-Endoxifen Hydrochloride (Selective Estrogen Receptor Modulator)

Trial Overview The trial is testing Z-endoxifen hydrochloride's safety and optimal dosage in patients whose breast cancer grows in response to estrogen. It includes lab biomarker analysis and pharmacological studies along with questionnaires about patient experiences.

Participant Groups

Group I: Treatment (Z-endoxifen hydrochloride) Experimental Treatment 4 Interventions

Patients receive Z-endoxifen hydrochloride PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

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