Tucatinib and trastuzumab given before other treatments for HER2‑positive rectal cancer

Neoadjuvant Tucatinib plus Trastuzumab in HER2-amplified Locally Advanced Rectal Cancer

NIH-funded research Sloan-Kettering Inst Can Research · NIH-11302663

People with HER2‑positive locally advanced rectal cancer will receive tucatinib plus trastuzumab up front to shrink tumors and possibly avoid radiation or surgery.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionSloan-Kettering Inst Can Research NIH-funded
Lab location1 site (New York, United States)
Project IDNIH-11302663 on NIH RePORTER

What this research studies

If your tumor biopsy shows HER2 amplification, you would start with 6 weeks of HER2‑targeted therapy using the oral drug tucatinib plus the antibody trastuzumab. After the initial 6 weeks, standard chemotherapy is added and the targeted drugs continue for about 4 more months. Your tumor will be rechecked with exams and imaging before the usual chemoradiation and again before surgery to see how much the tumor has shrunk. If a complete clinical response is seen, doctors may consider omitting radiation or surgery to reduce treatment side effects.

Who could benefit from this research

Good fit: Adults with locally advanced rectal cancer whose tumor tests positive for HER2 amplification and who can receive care at the study center are the intended candidates.

Not a fit: People whose tumors are not HER2‑amplified or who have widespread metastatic disease are unlikely to benefit from this specific approach.

Why it matters

Potential benefit: This approach could let some patients avoid radiation and/or surgery if their tumor responds completely to the targeted drugs.

How similar studies have performed: Targeting HER2 has shown benefit in some metastatic colorectal cancers and the team previously saw complete clinical responses with immunotherapy in mismatch repair deficient rectal cancer, but using tucatinib plus trastuzumab up front in HER2‑amplified rectal cancer is a new strategy.

Where this research is happening

New York, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.