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

Source: https://onco.cc/trials/nct05230810/  
OnCo record `nct05230810` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Alpelisib, Tucatinib and Fulvestrant in HER2-positive breast cancer, run by Criterium, Inc., active and no longer recruiting.

## Summary

Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. is a phase 1/2 interventional study registered as NCT05230810 by Criterium, Inc., with 40 participants enrolled, started 2022-08-25 and due to reach its primary completion in 2026-03-30. Interventions recorded: Alpelisib, Tucatinib and Fulvestrant.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT05230810
- Phase: 1/2
- Setting: This is a Multicenter, Single Arm, Open-label, run-in Phase Ib / Roll-over Phase II Study of Tucatinib in Combination With Alpelisib in Subjects With PIK3CA-mutant HER2-positive Locally Advanced Unresectable or Metastatic Breast Cancer.
- Sponsor: Criterium, Inc.
- Enrolled: 40

## Sources

- ClinicalTrials.gov NCT05230810: https://clinicaltrials.gov/study/NCT05230810

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- drugs: [Alpelisib](https://onco.cc/drugs/alpelisib/), [Fulvestrant](https://onco.cc/drugs/fulvestrant/), [Tucatinib](https://onco.cc/drugs/tucatinib/)
- companies: [Advanced Accelerator Applications (Novartis)](https://onco.cc/companies/advanced-accelerator-applications/), [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)

---
JSON: https://onco.cc/api/v1/entities/nct05230810.json