Actively Recruiting
Phase II Study of Tucatinib and Trastuzumab Combined with Chemotherapy for Locally Advanced HER2-Positive Rectal Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-12
37
Participants Needed
7
Research Sites
156 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a combination of the drugs trastuzumab and tucatinib alongside standard chemotherapy to treat participants with HER2-positive locally advanced rectal adenocarcinoma. This phase II study aims to assess whether adding these targeted drugs to standard treatment can help improve outcomes for people with this type of rectal cancer. Participants will receive tucatinib orally twice daily and trastuzumab by infusion during an initial 6-week lead-in period. Following this, all patients will continue with standard induction chemotherapy while still taking tucatinib and trastuzumab for an additional 15 weeks. The treatment focuses on combining these therapies to manage the cancer before surgery. During the study, participants will be closely monitored through clinical evaluations including imaging to assess the cancers response around 21 weeks after starting treatment. Researchers will measure the clinical complete response as the primary outcome. Safety and organ function will be regularly assessed, and participants will be followed for treatment adherence and overall health throughout the study period.
CONDITIONS
Brief Title
A Study of Tucatinib and Trastuzumab in People With Rectal Cancer
Research Team
A
Andrea Cercek, MD
R
Rona Yaeger, MD
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