Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in PIK3CA-mutated HER2+ Advanced BC (ALPHABET)

Study acronym: ALPHABET
StatusTerminated
PhasePhase 3
Started

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Record History

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  1. Trial terminated Sponsor's reason: Study prematurely terminated due to recruitment challenges, low incidence of the target population, evolving treatment landscape, ethical considerations, and inability to ensure funding through study completion. Show 7 more changesShow less
    • Primary completion date changed from estimate of Jun 2026 to Dec 23, 2025
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Study description revised
    • Site details revised at 4 of 106 sites
    • Publications: details revised at 1 of 1 entry
    • Study title shortened, about 6 words
  2. Primary and study completion dates: Jun 2025 to Jun 2026v9
  3. Primary and study completion dates: Nov 2024 to Jun 2025v8
  4. Enrollment target: estimated 300 to confirmed 27v7 Show 4 more changesShow less
    • Primary completion date: Jun 2026 to Nov 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Sep 2026 to Nov 2024
    • Site details revised at 106 of 106 sites
  5. Study sites: 108 to 106v6 Show 4 more changesShow less
    • Primary completion date: Jul 2026 to Jun 2026
    • Study completion date: Jul 2026 to Sep 2026
    • Eligibility criteria expanded, about 31 words
    • Study description expanded, about 2 words
Show 4 earlier versionsHide 4 earlier versions
  1. Publications expanded, about 46 wordsv5
  2. Study sites: 55 to 108
    • Study title shortened, about 2 words
    v4
  3. Study sites: 19 to 55v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2021 to Sep 14, 2021
    • Site details revised at 19 of 19 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer.
Trial Details
NCT Number NCT05063786
Lead Sponsor Spanish Breast Cancer Research Group
Collaborators: ETOP IBCSG Partners Foundation, Breast International Group, Novartis Pharmaceuticals
Conditions
(from sponsor)		 Advanced Breast Cancer
Related terms Breast Neoplasms
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov