๐๏ธ Verified NIH Record โข Updated 2026-03-13
Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. (NCT05230810)
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.
๐ต Active, Not Recruiting Phase1 / Phase2 ๐ Investigational Drug / Biologic Sponsor: Criterium, Inc.
๐ฉบ Plain-English Summary (8th-Grade Level)
Phase IB/II clinical trial of Alpelisb and Tucatinib in patients with PIK3CA-Mutant HER2-positive metastatic breast cancer.
Who can join: Review the eligibility criteria below.
Location: University of Colorado Cancer Center โ Aurora, Colorado
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (4 Sites)
- University of Colorado Cancer Center โ Aurora, Colorado
- Cancer Care & Hematology-Fort Collins โ Fort Collins, Colorado
- Louisiana State University Health Sciences Center โ New Orleans, Louisiana
- University of Wisconsin Carbone Cancer Center โ Madison, Wisconsin
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.