A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
Public ClinicalTrials.gov record NCT05132582. 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 Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)
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 when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.
Study identification
- NCT ID
- NCT05132582
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 654 participants
Conditions and interventions
Conditions
Interventions
- Tucatinib Drug
- Trastuzumab Drug
- Pertuzumab Drug
- Combination product: Trastuzumab + Pertuzumab Drug
- Placebo Drug
Drug
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
- Mar 7, 2022 (Actual)
- Primary completion
- Sep 5, 2025 (Actual)
- Completion
- Sep 28, 2027 (Estimated)
- Last update posted
- Sep 29, 2026
2022 – 2027
United States locations
- U.S. sites
- 76
- U.S. states
- 18
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI | Little Rock | Arkansas | 72205 | — |
| UCLA Hematology/Oncology - Beverly Hills | Beverly Hills | California | 90212 | — |
| UCLA Hematology/Oncology - Burbank | Burbank | California | 91505 | — |
| UCSD Medical Center - Encinitas | Encinitas | California | 92024 | — |
| Sulpizio Cardiovascular Center at UC San Diego Health | La Jolla | California | 92037 | — |
| UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) | La Jolla | California | 92037 | — |
| UCSD Koman Family Outpatient Pavilion | La Jolla | California | 92037 | — |
| UCSD Perlman Medical Offices | La Jolla | California | 92037 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| UCLA Hematology/Oncology - Laguna Hills | Laguna Hills | California | 92653 | — |
| Administrative Address: UCLA Hematology/Oncology | Los Angeles | California | 90095 | — |
| UCLA Hematology/Oncology | Los Angeles | California | 90095 | — |
| UCSD Medical Center - Bankers Hill | San Diego | California | 912101 | — |
| UC San Diego Medical Center - Hillcrest | San Diego | California | 92103 | — |
| UCLA Hematology/Oncology - San Luis Obispo | San Luis Obispo | California | 93401 | — |
| UCLA Hematology/Oncology- Santa Barbara | Santa Barbara | California | 93101 | — |
| UCLA Hematology/Oncology - Santa Monica | Santa Monica | California | 90404 | — |
| UCLA Hematology/Oncology Parkside | Santa Monica | California | 90404 | — |
| Clinical And Translational Research Center | Torrance | California | 90502 | — |
| The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Harbor-UCLA Medical Center | Torrance | California | 90509 | — |
| UCLA Hematology/Oncology - Santa Clarita | Valencia | California | 91355 | — |
| UCSD Medical Center - Vista | Vista | California | 92081 | — |
| UCLA Hematology/Oncology- Westlake | Westlake Village | California | 91361 | — |
| AdventHealth Altamonte Infusion Center | Altamonte Springs | Florida | 32701 | — |
| AdventHealth Medical Group Altamonte(second location) | Altamonte Springs | Florida | 32701 | — |
| AdventHealth Medical Group Altamonte | Altamonte Springs | Florida | 32701 | — |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | — |
| AdventHealth Medical Group Orlando | Orlando | Florida | 32804 | — |
| AdventHealth Orlando Infusion Center | Orlando | Florida | 32804 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Emory University Clinic | Atlanta | Georgia | 30322 | — |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | — |
| University of Illinois Hospital and Health Systems (Investigational Drug Pharmacy) | Chicago | Illinois | 60612 | — |
| University of Illinois Hospital and Health Systems (Outpatient Cancer Center) | Chicago | Illinois | 60612 | — |
| University of Illinois Hospital and Health Systems | Chicago | Illinois | 60612 | — |
| Norton Cancer Institute - Downtown | Louisville | Kentucky | 40202 | — |
| Norton Cancer Institute, Downtown | Louisville | Kentucky | 40202 | — |
| Norton Cancer Institute, St Matthews Campus | Louisville | Kentucky | 40207 | — |
| Norton Cancer Institute, St. Matthews Campus | Louisville | Kentucky | 40207 | — |
| Norton Cancer Institute, Brownsboro Hospital Campus | Louisville | Kentucky | 40241 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Saint Luke's Cancer Institute. | Kansas City | Missouri | 64111 | — |
| Oncology Hematology West PC dba Nebraska Cancer Specialists | Grand Island | Nebraska | 68803 | — |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island | Grand Island | Nebraska | 68803 | — |
| 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 | — |
| RWJBarnabas Health- Jersey City Medical Center | Jersey City | New Jersey | 07302 | — |
| RWJBarnabas Health- Monmouth Medical Center-Southern Campus | Lakewood | New Jersey | 08701 | — |
| RWJBarnabas Health- Cooperman Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| RWJBarnabas Health- Monmouth Medical Center | Long Branch | New Jersey | 07740 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| RWJBarnabas Health-Robert Wood Johnson University Hospital, Somerset | Somerville | New Jersey | 08876 | — |
| Steeplechase Cancer Center | Somerville | New Jersey | 08876 | — |
| RWJBarnabas Health - Community Medical Center | Toms River | New Jersey | 08755 | — |
| Satellite Infusion Center-Monmouth Medical Center Vantage Point Infusion Center | West Long Branch | New Jersey | 07764 | — |
| Montefiore Einstein Comprehensive Cancer Center | The Bronx | New York | 10461 | — |
| Cleveland Clinic Taussig Cancer Center Investigational Pharmacy | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Cleveland Clinic Cancer Center - Strongsville | Strongsville | Ohio | 44136 | — |
| Asplundh Cancer Pavillion | Willow Grove | Pennsylvania | 19090 | — |
| Tennessee Oncology, PLLC | Gallatin | Tennessee | 37066 | — |
| Tennessee Oncology, PLLC | Murfreesboro | Tennessee | 37129 | — |
| Sarah Cannon Research Institute- Pharmacy | Nashville | Tennessee | 37203 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | — |
| Tennessee Oncology, PLLC | Shelbyville | Tennessee | 37160 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| Froedtert Hospital/Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 231 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05132582, 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 Sep 29, 2026 · Synced Oct 19, 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 NCT05132582 live on ClinicalTrials.gov.