Open-label, single arm, multi-center, Phase II interventional pilot trial. Primary objective will be to assess participant satisfaction with the decentralized clinical trial (DCT) experience.~The trial will enroll men and pre- and post-menopausal women with a HR-positive/HER2-negative ABC (loco regionally recurrent not amenable to curative therapy or metastatic) with a PIK3CA mutation, which progressed on or after endocrine-based treatment.~Participants will receive alpelisib 300 mg daily and fulvestrant 500 mg administered intramuscularly on Cycle 1, Day 1 and Cycle 1, Day 15, and on Day 1 of each cycle thereafter until Cycle 12.~Pre-menopausal women will receive goserelin 3.6 mg on Day 1 of each cycle.
The study is designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements.