BYL719 + Letrozole for Breast Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Ingrid A Mayer, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Vanderbilt-Ingram Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when given together with letrozole in treating patients with hormone receptor-positive metastatic breast cancer. The PI3K inhibitor BYL719 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving the PI3K inhibitor BYL719 together with letrozole may kill more tumor cells

Eligibility Criteria

This trial is for post-menopausal women with hormone receptor-positive metastatic breast cancer. Participants must have had prior endocrine therapy, be able to swallow pills, and have a life expectancy of at least 6 months. They need proper organ function and no severe heart conditions or uncontrolled illnesses.

Inclusion Criteria

Life expectancy ≥ 6 months

Patients must provide informed written consent

ANC >/= 1,500/mm3

Exclusion Criteria

ST depression or elevation of ≥ 1.5 mm in 2 or more leads

Left Ventricular Ejection Fraction (LVEF) < 50%

I had radiation therapy more than 2 weeks ago and have recovered from its side effects.

Participant Groups

The study is testing the combination of BYL719 (a PI3K inhibitor) and letrozole to see if they are more effective together in stopping tumor growth compared to standard treatments. The trial will also determine the safest doses of BYL719 when used with letrozole.

Group I: Treatment (PI3K inhibitor BYL719, letrozole) Experimental Treatment 4 Interventions

Patients receive PI3K inhibitor BYL719 PO QD and letrozole PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Massachusetts General Hospital, Dana-Farber Cancer Institute Boston, MA

Vanderbilt-Ingram Cancer Center Nashville, TN

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References