Title
Phase 2 Study of Alpelisib and Fulvestrant for PIK3CA-mutated Estrogen Receptor (ER)-positive Endometrioid Endometrial Cancers

Description
This is a 2 stage multi-center study designed to evaluate the efficacy of the combination of alpelisib and fulvestrant in patients with PIK3CA-mutated ER-positive endometrioid endometrial cancers by estimating the objective response rate (ORR). Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.

Objective
To determine the objective response rate of the combination of alpelisib and fulvestrant in patients with advanced, persistent or recurrent PIK3CA-mutated ER-positive endometrioid endometrial cancer.
Secondary:
1. To describe the nature and degree of toxicity of the combination in this patient population.
2. To estimate the progression free survival (PFS) of this population while receiving the combination.
3. To estimate the duration of response (DOR) to therapy in this population.
4. To estimate the 24-month overall survival (OS) rate of this population while receiving the combination

Treatment Drug: Alpelisib Pill
Drug: Fulvestrant injection

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Uterus

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital