A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer
Public ClinicalTrials.gov record NCT02614794. 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
Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer. There are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo. The second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.
Study identification
- NCT ID
- NCT02614794
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 612 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
- Jan 28, 2016 (Actual)
- Primary completion
- Sep 4, 2019 (Actual)
- Completion
- Aug 11, 2022 (Actual)
- Last update posted
- Aug 14, 2023
2016 – 2022
United States locations
- U.S. sites
- 81
- U.S. states
- 30
- U.S. cities
- 69
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| University of South Alabama - Mitchell Cancer Institute | Mobile | Alabama | 36604 | — |
| Cancer Treatment Centers of America - Phoenix | Goodyear | Arizona | 85338 | — |
| Arizona Oncology Associates, PC - HAL | Phoenix | Arizona | 85016 | — |
| City of Hope National Medical Center | Duarte | California | 91010-3000 | — |
| TRIO - Central Regulatory Office | Los Angeles | California | 90095 | — |
| UCLA Medical Center / David Geffen School of Medicine | Los Angeles | California | 90095 | — |
| Torrance Memorial Physician Network - TRIO | Redondo Beach | California | 90277 | — |
| University of California at San Francisco | San Francisco | California | 94134 | — |
| Kaiser Permanente San Marcos Medical Offices | San Marcos | California | 92078 | — |
| Central Coast Medical Oncology Corporation TRIO | Santa Maria | California | 93454 | — |
| Kaiser Permanente Medical Center Northern California | Vallejo | California | 94589 | — |
| University of Colorado Hospital / University of Colorado | Aurora | Colorado | 80045-0510 | — |
| Yale Cancer Center | New Haven | Connecticut | 06520 | — |
| Lombardi Cancer Center / Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Florida Cancer Specialists - South Region | Fort Myers | Florida | 33901 | — |
| Memorial Regional Hospital TRIO | Hollywood | Florida | 33021 | — |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Mount Sinai Medical Center / Florida | Miami Beach | Florida | 33140 | — |
| Orlando Health, Inc. TRIO | Orlando | Florida | 32806 | — |
| Florida Cancer Specialists - North Region | St. Petersburg | Florida | 33705 | — |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | — |
| Florida Cancer Specialists - East West Palm Beach, FL (SCRI) | West Palm Beach | Florida | 33401 | — |
| Winship Cancer Institute / Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Northside Hospital | Atlanta | Georgia | 30342 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Cancer Treatment Centers of America | Newnan | Georgia | 30265 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Chicago | Chicago | Illinois | 60637-1470 | — |
| Illinois Cancer Specialists / Advocate Lutheran General Hospital | Niles | Illinois | 60714 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Maryland Oncology Hematology, P.A. | Rockville | Maryland | 20850 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55407 | — |
| Saint Luke's Cancer Institute LLC | Kansas City | Missouri | 64113 | — |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| Dartmouth-Hitchcock Medical Center/ Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Mount Sinai Beth Israel | New York | New York | 10003 | — |
| New York University (NYU) Cancer Institute | New York | New York | 10016 | — |
| Stony Brook University Cancer Center | Stony Brook | New York | 11794 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| UNC Lineberger Comprehensive Cancer Center / University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Leo W. Jenkins Cancer Services / Brody School of Medicine East Carolina University | Greenville | North Carolina | 27834 | — |
| James Cancer Hospital / Ohio State University | Columbus | Ohio | 43210 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Oregon Health and Science University | Portland | Oregon | 97239-3098 | — |
| Northwest Cancer Specialists, P.C. | Tualatin | Oregon | 97062 | — |
| University of Pennsylvania / Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Cancer Treatment Centers of America / Eastern Regional Medical Center | Philadelphia | Pennsylvania | 19124 | — |
| Roper St. Francis Healthcare | Charleston | South Carolina | 29414 | — |
| Medical University of South Carolina/Hollings Cancer Center | Charleston | South Carolina | 29425 | — |
| Wellmont Cancer Institute | Kingsport | Tennessee | 37660 | — |
| Tennessee Oncology - Nashville | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37204 | — |
| Texas Oncology - Austin Midtown | Austin | Texas | 78705 | — |
| Texas Oncology Methodist | Dallas | Texas | 75203 | — |
| Texas Oncology - Denton South | Denton | Texas | 76210 | — |
| The Center for Cancer and Blood Disorders: Fortworth | Fort Worth | Texas | 76104 | — |
| Texas Oncology - Houston Memorial City | Houston | Texas | 77024 | — |
| MD Anderson Cancer Center / University of Texas | Houston | Texas | 77030-4095 | — |
| Baylor Clinic | Houston | Texas | 77030 | — |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | — |
| Paris Regional Medical Center / US Oncology | Paris | Texas | 75460 | — |
| Texas Oncology - Plano East | Plano | Texas | 75075 | — |
| Texas Oncology - San Antonio Medical Center Northeast | San Antonio | Texas | 78212 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| US Oncology Central Regulatory | The Woodlands | Texas | 77380 | — |
| Texas Oncology - Deke Slayton Cancer Center | Webster | Texas | 77598 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Shenandoah Oncology P.C. | Winchester | Virginia | 22601 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
| Seattle Cancer Care Alliance / University of Washington | Seattle | Washington | 98109-1023 | — |
| Carbone Cancer Center / University of Wisconsin | 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 95 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02614794, 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 Aug 14, 2023 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02614794 live on ClinicalTrials.gov.