What the trial was testing
The MOUNTAINEER enrolled 117 patients with colorectal cancer. The study was sponsored by Seagen and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
38% tumor response rate in chemo-refractory HER2+ colon cancer.
The Lancet Oncology · 2023 · NCT03043313
These findings — that in chemotherapy-refractory HER2-positive metastatic colorectal cancer — were published in the The Lancet Oncology and represent the headline result of the study.
Researchers tracked outcomes across 117 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with colorectal cancer, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Tucatinib (Tukysa) plus trastuzumab is FDA-approved and available now for chemotherapy-refractory HER2-positive metastatic colorectal cancer — the first targeted regimen specifically approved for this group. Ask an oncologist about HER2 testing on your tumor.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open colorectal cancer trials
Predicting the Efficacy of Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer Using an AI Platform Based on Multi-parametric MRI
Establish a deep learning model based on multi-parameter magnetic resonance imaging to predict the efficacy of neoadjuvant therapy for locally advanced rectal cancer.This study intends to combine DCE with conventional MRI images for DL, establish a multi-parameter MRI model for predicting the efficacy of CRT, and compare it with the DL and non-artificial quantitative MRI diagnostic model constructed by conventional MRI to evaluate the role of DL in MRI predicting CRT. And this study also tries to build a DL platform to assess the efficacy of LARC neoadjuvant radiotherapy and chemotherapy, accurately assess patients' complete respose (pCR) after CRT, and provide an important basis for guiding clinical decision-making.
Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients
This study collects blood and stool samples from patients with suspected or diagnosed Lynch syndrome to evaluate a deoxyribonucleic acid (DNA) screening technique for the detection of colorectal cancer in Lynch syndrome patients.