Alpelisib + Enzalutamide for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByMeghan Karuturi

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests the combination of alpelisib and enzalutamide in patients with advanced breast cancer that has specific markers. The drugs work together to block cancer cell growth and reduce hormone levels, aiming to improve treatment outcomes. Alpelisib is a unique drug approved for the treatment of patients with estrogen receptor-positive metastatic breast cancer.

Eligibility Criteria

This trial is for adults with metastatic breast cancer that's hormone-receptor positive or triple-negative, and not suitable for surgery/radiation. Participants must have stable health, meet specific blood/lab criteria, and not be pregnant or breastfeeding. They should agree to use effective contraception if of childbearing potential.

Participant Groups

The trial tests the combination of Alpelisib and Enzalutamide in patients with advanced breast cancer. It aims to find the best dose while assessing side effects. Alpelisib blocks enzymes needed for tumor growth; Enzalutamide lowers body's androgen to combat cancer cell growth.

1Treatment groups

Experimental Treatment

Group I: Treatment (alpelisib, enzalutamide)Experimental Treatment2 Interventions

Patients receive alpelisib PO and enzalutamide PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Alpelisib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Piqray for:

Hormone receptor-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen

🇪🇺 Approved in European Union as Piqray for: