Tucatinib and trastuzumab given before other treatments for HER2‑positive rectal cancer
Official title: Neoadjuvant Tucatinib plus Trastuzumab in HER2-amplified Locally Advanced Rectal Cancer
Funded at Sloan-Kettering Inst Can Research · NIH-11302663 · Data updated 2026-11-12
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 type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Sloan-Kettering Inst Can Research NIH-funded |
| Lab location | 1 site (New York, United States) |
| Project start | March 1, 2024 |
| Project end | February 28, 2029 |
| Funding year | 2026 |
| Award (this year) | $402,600 |
| NIH project number | 5R01CA288880-03 |
| Project ID | NIH-11302663 on NIH RePORTER |
Who could benefit from this research
✓Could help
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.
✕Less likely to help
People whose tumors are not HER2‑amplified or who have widespread metastatic disease are unlikely to benefit from this specific approach.
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.
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 gone: 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
-
Sloan-Kettering Inst Can Research
New York, United States Active
Researchers
- Principal investigator: Cercek, Andrea — Sloan-Kettering Inst Can Research
- Study coordinator: Cercek, Andrea
Related research
Other NIH-funded projects on the same topics.
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Blood tests to predict who will respond to pre-surgery therapy for locally advanced rectal cancer
A blood-based test is being developed to predict which patients with locally advanced rectal cancer will respond to neoadjuvant chemoradiation before surgery.
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Predicting who responds to preoperative therapy for rectal cancer using combined photoacoustic and ultrasound imaging
A study is testing a new imaging method to better predict which locally advanced rectal cancer patients will respond to preoperative treatment so some may avoid unnecessary surgery.
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Dose levels of aerobic exercise during cancer therapy for rectal cancer
A personalized exercise plan is tested to see how different amounts of aerobic training affect how well people with locally advanced rectal cancer tolerate their treatment.
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Identifying blood markers to predict treatment response in rectal cancer patients
This study is looking at how a new blood test can help doctors figure out which patients with locally advanced rectal cancer will respond well to their treatment before they start, so they can tailor the therapy to each person and avoid unnecessary side effects.
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Using advanced imaging to predict treatment response in rectal cancer
This study is looking to help people with locally advanced rectal cancer by using new imaging methods to better understand how well they respond to treatment before surgery, which could help doctors make smarter choices and possibly spare some patients from unnecessary operations.
-
Effects of aerobic training on cancer treatment tolerability in rectal cancer patients
This study is looking at how different amounts of aerobic exercise can help people with locally advanced rectal cancer feel better and handle their treatment more easily, and it’s designed for patients who are about to start their cancer therapy.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.