Hormone Therapy for Breast Cancer

Palo Alto (17 mi)

Overseen byBhuvaneswari Ramawamy, MD

Age: 65+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II clinical trial studies how well fulvestrant and palbociclib works in treating older patients with breast cancer that responds to hormone treatment (hormone responsive) that cannot be removed by surgery. Estrogen can cause the growth of estrogen-receptor-positive breast cancer cells. Hormone therapy using fulvestrant may fight estrogen-receptor-positive breast cancer by blocking the use of estrogen by the tumor cells. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant together with palbociclib may be an effective treatment for hormone responsive breast cancer.

Eligibility Criteria

This trial is for older patients with hormone-responsive breast cancer that can't be surgically removed. Participants must have normal levels of bilirubin, creatinine, and liver enzymes, not have had prior aromatase inhibitor therapy or strong CYP3A4 drugs, and no distant metastases. They should also meet certain health criteria indicating they are vulnerable or frail according to Balducci Criteria.

Inclusion Criteria

My breast cancer is ER/PR positive and HER2 negative, with more than 10% staining.

I have chosen not to undergo surgery for my breast cancer, as noted by my surgeon and oncologist.

Exclusion Criteria

My cancer has spread to distant parts of my body.

I am not taking medication that strongly affects liver enzyme CYP3A4.

I have previously been treated with aromatase inhibitors.

Treatment Details

The study tests the effectiveness of combining fulvestrant (a hormone therapy) with palbociclib (an enzyme blocker) in treating estrogen-receptor-positive breast cancer. The goal is to see if this combination helps stop tumor growth by blocking estrogen use and cell growth enzymes.

1Treatment groups

Experimental Treatment

Group I: Treatment (fulvestrant, palbociclib)Experimental Treatment5 Interventions

Patients receive fulvestrant IM on days 1 and 15. Patients also receive palbociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Fulvestrant is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Faslodex for: