NCT05230810

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

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.

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Criterium, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase IB/II clinical trial of Alpelisb and Tucatinib in patients with PIK3CA-Mutant HER2-positive metastatic breast cancer.

Detailed description

This study is a multicenter, single arm, open-label, run-in phase Ib safety cohort with immediate roll over to a phase II clinical trial that will test the combination therapy of tucatinib with alpelisib in subjects with PIK3CA-mutant HER2+ locally advanced unresectable or metastatic breast cancer. Patients with PIK3CA-mutant HR-/HER2+ and HR+/HER2+ breast cancer may enroll, the latter cohort will receive concomitant treatment with standard doses of fulvestrant to block HR signaling. In phase Ib part, we will confirm the tolerability of tucatinib and alpelisib combination and determine the maximum tolerated dose (MTD). In phase II part, we will expand the testing of this drug combination at MTD to determine the PFS rate.

Conditions

• HER2-positive Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Alpelisib	Orally twice a day
DRUG	Tucatinib	Orally once a day
DRUG	Fulvestrant	500 mg intramuscularly into the buttocks slowly \*Fulvestrant will be administered only in patients with HR+/HER2+ metastatic breast cancer

Timeline

• Start date: 2022-08-25
• Primary completion: 2026-03-30
• Completion: 2026-06-30
• First posted: 2022-02-09
• Last updated: 2026-03-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study