BYL719 + Letrozole for Breast Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Vanderbilt-Ingram Cancer Center

Must be taking: Letrozole

Must not be taking: CYP3A4 modifiers, QT prolonging

Disqualifiers: Diabetes, Heart failure, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

46 Participants Needed

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

Research Team

Ingrid A Mayer, MD

Principal Investigator

Vanderbilt-Ingram Cancer Center

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BYL719 and letrozole orally once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

8 weeks

Weekly monitoring for dose-limiting toxicities

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• BYL719
• Letrozole

Trial Overview 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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+