Clinical Trial

Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

Active, Not Recruiting Phase 1/2
View on ClinicalTrials.gov →
Record status
This record was last updated March 16, 2026 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Phase IB/II clinical trial of Alpelisb and Tucatinib in patients with PIK3CA-Mutant HER2-positive metastatic breast cancer.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2022-01-28; most recent amendment 2026-03-13.
Status change: Recruiting → Active, Not Recruiting 2026-03-13
Status change: Not Yet Recruiting → Recruiting 2022-10-14
Trial Details
NCT Number NCT05230810
Lead Sponsor Criterium, Inc.
Collaborators: Novartis, Seagen Inc.
Conditions HER2-positive Metastatic Breast Cancer
Enrollment 40 participants
Start Date 2022-08-25
Primary Completion 2026-03-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-16