A Randomized Phase III Trial of Trastuzumab + ALpelisib +/- Fulvestrant Versus Trastuzumab + Chemotherapy in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer. "ALPHABET Study".

NCT05063786 Phase 3 ACTIVE_NOT_RECRUITING

Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer.

Details

Lead sponsor	Spanish Breast Cancer Research Group
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	27
Start date	2021-09-14
Completion	2026-06

Conditions

• Advanced Breast Cancer

Interventions

• Trastuzumab
• Alpelisib
• Fulvestrant
• Vinorelbine
• Capecitabine
• Eribulin

Primary outcomes

• Progression Free Survival (PFS) — The accumulation of targeted PFS events is estimated at 44 and 38 months since first patients randomized, in the HR- and HR+ cohorts, respectively.
  Time from randomization to objective disease progression based on the investigator's assessment according to the response evaluation criteria for solid tumors (RECIST) version 1.1., or death from any cause.

Countries

Austria, France, Italy, Netherlands, Spain, Switzerland