Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer
Public ClinicalTrials.gov record NCT03043313. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
MOUNTAINEER: A Phase II, Open Label Study of Tucatinib Combined With Trastuzumab in Patients With HER2+ Metastatic Colorectal Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body. In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.
Study identification
- NCT ID
- NCT03043313
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 117 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 23, 2017 (Actual)
- Primary completion
- Mar 28, 2022 (Actual)
- Completion
- Nov 2, 2023 (Actual)
- Last update posted
- Nov 26, 2024
2017 – 2023
United States locations
- U.S. sites
- 41
- U.S. states
- 25
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| Pacific Shores Medical Group | Long Beach | California | 90813 | — |
| Keck Medical Center / University of Southern California | Los Angeles | California | 90033 | — |
| Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | 90048 | — |
| Stanford University School of Medicine | Palo Alto | California | 94304 | — |
| Saint Joseph Heritage Medical Group | Santa Rosa | California | 95403 | — |
| Rocky Mountain Cancer Centers - Aurora | Aurora | Colorado | 80012 | — |
| Lombardi Cancer Center / Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Florida Cancer Specialists - South Region | Fort Myers | Florida | 33901 | — |
| Florida Cancer Specialists - North Region | St. Petersburg | Florida | 33705 | — |
| Winship Cancer Institute / Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637-1470 | — |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Karmanos Cancer Institute / Wayne State University | Detroit | Michigan | 48201 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14203 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Case Western Reserve University / University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97227 | — |
| Oregon Health and Science University | Portland | Oregon | 97239-3098 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Tennessee Oncology-Nashville/Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Oncology - Beaumont | Beaumont | Texas | 77702-1449 | — |
| Texas Oncology - Baylor Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | — |
| Texas Oncology - McAllen | McAllen | Texas | 78503 | — |
| Texas Oncology - San Antonio Medical Center | San Antonio | Texas | 78240 | — |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
| Providence Regional Medical Center Everett | Everett | Washington | 98201 | — |
| Seattle Cancer Care Alliance / University of Washington | Seattle | Washington | 98109-1023 | — |
| Aurora Research Institute Cancer Center | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03043313, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 26, 2024 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03043313 live on ClinicalTrials.gov.