Evidence map›Paper›PMID 41526345›Full record

Trial reportNature communications2026

Tucatinib plus trastuzumab for chemotherapy-refractory, HER2 + , RAS wild-type metastatic colorectal cancer (MOUNTAINEER): final analysis.

John H Strickler, Andrea Cercek, Salvatore Siena, Thierry André, Kimmie Ng, Eric Van Cutsem, Christina Wu, Andrew Scott Paulson, Joleen M Hubbard, Andrew L Coveler and 13 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03043313 (MOUNTAINEER), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03043313 phase2completednot on this map

MOUNTAINEER: A Phase II, Open Label Study of Tucatinib Combined With Trastuzumab in Patients With HER2+ Metastatic Colorectal Cancer

TypeinterventionalSponsorSeagen Inc.Ran2017 to 2023Enrolled117ConditionsMetastatic Colorectal AdenocarcinomaArmsTrastuzumab, Tucatinib
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

John H StricklerDuke University Medical Center, Durham, NC, USA.ORCID http://orcid.org/0000-0001-7579-1175
Andrea CercekMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Salvatore SienaUniversità degli Studi di Milano, Milan, Italy.ORCID http://orcid.org/0000-0002-2681-2846
Thierry AndréDepartment of Medical Oncology, Sorbonne University, Saint-Antoine Hospital, AP-HP, Paris, France.ORCID http://orcid.org/0000-0002-5103-7095
Kimmie NgDana-Farber Cancer Institute, Boston, MA, USA.ORCID http://orcid.org/0000-0003-0631-1494
Eric Van CutsemUniversity Hospital Gasthuisberg and University of Leuven, Leuven, Belgium.
Christina WuMayo Clinic, Phoenix, AZ, USA.
Andrew Scott PaulsonTexas Oncology/The US Oncology Network, Dallas, TX, USA.
Joleen M HubbardMayo Clinic, Rochester, MN, USA.
Andrew L CovelerFred Hutchinson Cancer Center, University of Washington, Seattle, WA, USA.
Christos FountzilasRoswell Park Comprehensive Cancer Center, Buffalo, NY, USA.ORCID http://orcid.org/0000-0003-3837-5644
Adel KardoshOHSU Knight Cancer Institute, Portland, OR, USA.
Pashtoon Murtaza KasiWeill Cornell Medicine, New York City, NY, USA.ORCID http://orcid.org/0000-0002-5169-7085
Heinz-Josef LenzUSC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.ORCID http://orcid.org/0000-0003-2178-9568
Kristen CiomborVanderbilt University Medical Center, Nashville, TN, USA.
Elena ElezVall d'Hebron University Hospital, Barcelona, Spain.ORCID http://orcid.org/0000-0002-4653-6324
David L BajorCase Western Reserve University-University Hospitals Cleveland Medical Center, Cleveland, OH, USA.
Chiara CremoliniAzienda Ospedaliero-Universitaria Pisana and Università di Pisa, Pisa, Italy.ORCID http://orcid.org/0000-0002-0520-4841
Federico SanchezAurora Research Institute Cancer Center, Milwaukee, WI, USA.
Mina NayeriPfizer Inc, Bothell, WA, USA.
Wentao FengPfizer Inc, Bothell, WA, USA.
Mark BiedaPfizer Inc, Bothell, WA, USA.
Tanios S Bekaii-SaabMayo Clinic Arizona, Phoenix, AZ, USA. Bekaii-Saab.Tanios@mayo.edu.ORCID http://orcid.org/0000-0001-7721-1699

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

MOUNTAINEER was a multicenter, open-label, phase 2 trial (NCT03043313) that evaluated the efficacy and safety of tucatinib plus trastuzumab, a dual HER2-targeted chemotherapy-free regimen. Patients were included if they had chemotherapy-refractory, HER2+, RAS wild-type unresectable or metastatic colorectal cancer. This final analysis reports updated efficacy and safety after a median follow-up of 32.4 months. Of the 84 patients who received tucatinib plus trastuzumab, the confirmed objective response rate was 39.3%; median duration of response was 15.2 months. Median progression-free survival was 8.1 months and overall survival was 23.9 months. Efficacy was relatively similar across central HER2+ testing methods. No clear association of treatment response with co-occurring biomarker alterations was seen. Few patients discontinued treatment due to adverse events; no treatment-emergent deaths occurred. Tucatinib plus trastuzumab showed clinically meaningful efficacy and favorable safety. Efficacy was observed irrespective of central HER2+ testing methods and in patients with heterogeneous tumor biomarker profiles.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsErb-b2 Receptor Tyrosine KinasesOxazolesPyridinesQuinazolinesTrastuzumabAdultAgedAged, 80 and overBiomarkers, TumorDrug Resistance, NeoplasmFemaleHumansMaleMiddle AgedBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesOxazolesPyridinesQuinazolinesTrastuzumabtucatinib

Identifiers

PMID41526345
PMCPMC12852713

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.