NCT04762979 - Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 12, 2021

Primary Completion Date

September 30, 2025

Study Completion Date

January 31, 2026

Conditions

Hormone Receptor Positive Breast CarcinomaHER2-negative Breast CancerPIK3CA Mutant Metastatic Breast Cancer

Interventions

DRUG

Alpelisib

Alpelisib 300mg, PO, days 1-28 of each cycle.

DRUG

Fulvestrant

Fulvestrant 500mg, IM, once monthly

DRUG

Aromatase inhibitor

Aromatase Inhibitor, administered per standard of care

Trial Locations (4)

RECRUITING

Penn State Cancer Institute, Hershey

ACTIVE_NOT_RECRUITING

University of Wisconsin, Madison

RECRUITING

University of Illinois Cancer Center, Chicago

RECRUITING

University of Nebraska Medical Center, Omaha