ClinicalTrials.gov record
A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer
ClinicalTrials.gov ID: NCT04539938
Public ClinicalTrials.gov record NCT04539938. 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
A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination With Trastuzumab Deruxtecan in Subjects With Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast 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 deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and T-DXd.
Study identification
- NCT ID
- NCT04539938
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 70 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
- Dec 1, 2020 (Actual)
- Primary completion
- Jul 15, 2024 (Actual)
- Completion
- Mar 7, 2025 (Actual)
- Last update posted
- Mar 23, 2026
2020 – 2025
United States locations
- U.S. sites
- 140
- U.S. states
- 20
- U.S. cities
- 95
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| University of Alabama at Birmingham, IDS Pharmacy | Birmingham | Alabama | 35249 | — |
| University Of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85704 | — |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85711 | — |
| UCLA Hematology/Oncology - Alhambra | Alhambra | California | 91801 | — |
| UCLA Hematology/Oncology - Burbank | Burbank | California | 91505 | — |
| City of Hope (City of Hope National Medical Center, City of Hope Medical center) | Duarte | California | 91010 | — |
| City of Hope Investigational Drug Services (IDS) | Duarte | California | 91010 | — |
| UCLA Hematology/Oncology - Laguna Hills | Laguna Hills | California | 92653 | — |
| (IRB# 20-001502) Ronald Reagan UCLA Medical Center, Drug Information Center | Los Angeles | California | 90095 | — |
| UCLA Hematology/Oncology | Los Angeles | California | 90095 | — |
| UCLA Hematology/Oncology - Pasadena | Pasadena | California | 91105 | — |
| Zuckerberg San Francisco General Hospital- Breast Clinic | San Francisco | California | 94110 | — |
| Zuckerberg San Francisco General Hospital- Oncology Clinic | San Francisco | California | 94110 | — |
| University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | — |
| UCLA Hematology/Oncology - San Luis Obispo | San Luis Obispo | California | 93401 | — |
| UCLA Hematology/Oncology - Santa Barbara | Santa Barbara | California | 93105 | — |
| UCLA Hematology/Oncology - Santa Monica | Santa Monica | California | 90404 | — |
| UCLA Hematology/Oncology Parkside | Santa Monica | California | 90404 | — |
| UCLA Hematology/Oncology - Ventura | Ventura | California | 93003 | — |
| UCLA Hematology/Oncology - Westlake | Westlake Village | California | 91361 | — |
| University of Colorado Denver CTO/CTRC - Outpatient. | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) | Aurora | Colorado | 80045 | — |
| UC Health Lone Tree Medical Center | Lone Tree | Colorado | 80124 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Washington Cancer Institute at MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Florida Cancer Specialists | Altamonte Springs | Florida | 32701 | — |
| Florida Cancer Specialists | Brandon | Florida | 33511 | — |
| Florida Cancer Specialists | Clearwater | Florida | 33761 | — |
| Florida Cancer Specialists | Gainesville | Florida | 32605 | — |
| Florida Cancer Specialists | Largo | Florida | 33770 | — |
| Florida Cancer Specialists | Lecanto | Florida | 34461 | — |
| Florida Cancer Specialists | Ocala | Florida | 34474 | — |
| Florida Cancer Specialists | Orange City | Florida | 32763 | — |
| Florida Cancer Specialists | Orlando | Florida | 32806 | — |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | — |
| Florida Cancer Specialists | Tampa | Florida | 33607 | — |
| Florida Cancer Specialists | Tavares | Florida | 32778 | — |
| Florida Cancer Specialists | The Villages | Florida | 32159 | — |
| Florida Cancer Specialists | Trinity | Florida | 34655 | — |
| Florida Cancer Specialists | Winter Park | Florida | 32789 | — |
| Northside Hospital, Inc - GCS/Athens | Athens | Georgia | 30606 | — |
| Winship Cancer Institute @ Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| The Emory Clinic | Atlanta | Georgia | 30322 | — |
| Winship Cancer Institute / Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Atlanta Cancer Care - Atlanta | Atlanta | Georgia | 30342 | — |
| Northside Hospital, Inc. - Central Research Department | Atlanta | Georgia | 30342 | — |
| Northside Hospital, Inc. - GCS/Center Pointe | Atlanta | Georgia | 30342 | — |
| Northside Hospital, Inc - GCS/Blairsville | Blairsville | Georgia | 30512 | — |
| Northside Hospital, Inc - GCS/Canton | Canton | Georgia | 30114 | — |
| Atlanta Cancer Care - Cumming | Cumming | Georgia | 30041 | — |
| Northside Hospital, Inc. - GCS/Decatur | Decatur | Georgia | 30033 | — |
| NHCI Suburban Hematology-oncology Associates - Duluth | Duluth | Georgia | 30096 | — |
| NHCI Suburban Hematology-oncology Associates - lawrenceville | Lawrenceville | Georgia | 30046 | — |
| Northside Hospital, Inc - GCS/Macon | Macon | Georgia | 31217 | — |
| Northside Hospital, Inc. - GCS/Marietta | Marietta | Georgia | 30060 | — |
| Atlanta Cancer Care - Stockbridge | Stockbridge | Georgia | 30281 | — |
| Harry and Jeanette Weinberg Cancer Institute at Franklin Square | Baltimore | Maryland | 21237 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Dana Farber Cancer Institute- Chestnut Hill | Newton | Massachusetts | 02459 | — |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | — |
| Minnesota Oncology Hematology, PA | Coon Rapids | Minnesota | 55433 | — |
| Mercy Hospital - Unity Campus | Fridley | Minnesota | 55432 | — |
| Minnesota Oncology Hematology, PA | Fridley | Minnesota | 55433 | — |
| Minnesota Oncology Hematology, PA | Minneapolis | Minnesota | 55404 | — |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Allina Health Cancer institute | Minneapolis | Minnesota | 55407 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Allina Health Cancer Institute | Saint Paul | Minnesota | 55102 | — |
| Minnesota Oncology Hematology PA | Saint Paul | Minnesota | 55102 | — |
| Minnesota Oncology Hematology, PA | Saint Paul | Minnesota | 55102 | — |
| United Hospital | Saint Paul | Minnesota | 55102 | — |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Omaha | Nebraska | 68114 | — |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Omaha | Nebraska | 68124 | — |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Papillion | Nebraska | 68046 | — |
| MSK Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| MSK Monmouth | Middletown | New Jersey | 07748 | — |
| MSK Bergen | Montvale | New Jersey | 07645 | — |
| MSK Commack | Commack | New York | 11725 | — |
| MSK Westchester | Harrison | New York | 10604 | — |
| Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy | Long Island City | New York | 11101 | — |
| Evelyn H. Lauder Breast and Imaging Center (BAIC). | New York | New York | 10065 | — |
| MSK Nassau | Uniondale | New York | 11553 | — |
| Providence Cancer Institute Franz Clinic | Portland | Oregon | 97213 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| UPMC Hillman Cancer Center Passavant North | Cranberry Township | Pennsylvania | 16066 | — |
| UPMC Hillman Cancer Center Erie | Erie | Pennsylvania | 16505 | — |
| UPMC Hillman Cancer Center Mountainview | Greensburg | Pennsylvania | 15601 | — |
| UPMC Hillman Cancer Center UPMC East | Monroeville | Pennsylvania | 15146 | — |
| UPMC Hillman Cancer Center Upper Saint Clair | Pittsburgh | Pennsylvania | 15102 | — |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | — |
| University of Pittsburgh Cancer Institute Investigational Drug Service UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| UPMC Cancer Centers William M. Cooper Ambulatory Care Pavilion of the Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| UPMC Hillman Cancer Center UPMC Passavant | Pittsburgh | Pennsylvania | 15237 | — |
| UPMC Hillman Cancer Center Uniontown | Uniontown | Pennsylvania | 15401 | — |
| UPMC Hillman Cancer Center Washington | Washington | Pennsylvania | 15301 | — |
| Tennessee Oncology, PLLC | Chattanooga | Tennessee | 37403 | — |
| Sarah Cannon Research Institute | Chattanooga | Tennessee | 37404 | — |
| Tennessee Oncology, PLLC | Chattanooga | Tennessee | 37404 | — |
| Tennessee Oncology, PLLC | Cleveland | Tennessee | 37311 | — |
| Tennessee Oncology, PLLC | Dickson | Tennessee | 37055 | — |
| Tennessee Oncology, PLLC | Franklin | Tennessee | 37067 | — |
| Tennessee Oncology, PLLC | Gallatin | Tennessee | 37066 | — |
| Tennessee Oncology, PLLC | Hendersonville | Tennessee | 37075 | — |
| Tennessee Oncology, PLLC | Hermitage | Tennessee | 37076 | — |
| Tennessee Oncology, PLLC | Lebanon | Tennessee | 37909 | — |
| Tennessee Oncology, PLLC | Murfreesboro | Tennessee | 37129 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | — |
| The Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37205 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37207 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37211 | — |
| Tennessee Oncology, PLLC | Shelbyville | Tennessee | 37160 | — |
| Tennessee Oncology, PLLC | Smyrna | Tennessee | 37167 | — |
| The University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | — |
| U.T. MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| US Oncology Investigational Product Center (IPC) | Irving | Texas | 75063 | — |
| US Oncology Investigational Products Center (IPC) | Irving | Texas | 75063 | — |
| US Oncology lnvestigational Products Center (IPC) | Irving | Texas | 75063 | — |
| Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care | Blacksburg | Virginia | 24060 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Virginia Cancer Specialists, PC | Gainesville | Virginia | 20155 | — |
| Virginia Cancer Specialists, PC | Leesburg | Virginia | 20176 | — |
| Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care | Low Moor | Virginia | 24457 | — |
| Virginia Cancer Specialists, PC | Reston | Virginia | 20190 | — |
| Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | — |
| Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care | Salem | Virginia | 24153 | — |
| Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care | Wytheville | Virginia | 24382 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| UW Health Oncology - One South Park | Madison | Wisconsin | 53715 | — |
| University of Wisconsin Clinical Science Center | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04539938, 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 Mar 23, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04539938 live on ClinicalTrials.gov.