Clinical Trial

Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)

Study acronym: ALPHABET
Active, Not Recruiting Phase 3
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Record status
This record was last updated September 8, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2021-09-21; most recent amendment 2025-09-05.
Status change: Recruiting → Active, Not Recruiting 2024-04-09
Status change: Not Yet Recruiting → Recruiting 2021-11-10
Trial Details
NCT Number NCT05063786
Lead Sponsor Spanish Breast Cancer Research Group
Collaborators: ETOP IBCSG Partners Foundation, Breast International Group, Novartis Pharmaceuticals
Conditions Advanced Breast Cancer
Enrollment 27 participants
Start Date 2021-09-14
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-09-08