Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05132582 · ClinicalTrials.gov registry record · Phase 3
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
A Phase 3 study of HER2-positive Breast Cancer, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 654
- Enrollment target
- 20
- Study locations
NCT05132582: Active Phase 3 study of HER2-positive Breast Cancer, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
NCT05132582 is a Phase 3 study of HER2-positive Breast Cancer that is active but no longer recruiting, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 654 participants, above the 224-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (192% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05132582, a Phase 3 study of HER2-positive Breast Cancer, is active but no longer recruiting, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 654 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The time from the date of randomization to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Placebo
- DRUG Tucatinib
- DRUG Pertuzumab
- DRUG Combination product: Trastuzumab + Pertuzumab
Study Locations (20)
California
- UCLA Hematology/Oncology - Beverly Hills - Beverly Hills
- UCLA Hematology/Oncology - Burbank - Burbank
- UCSD Medical Center - Encinitas - Encinitas
- Sulpizio Cardiovascular Center at UC San Diego Health - La Jolla
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) - La Jolla
- UCSD Koman Family Outpatient Pavilion - La Jolla
- UCSD Perlman Medical Offices - La Jolla
- UC San Diego Moores Cancer Center - La Jolla
- UCLA Hematology/Oncology - Laguna Hills - Laguna Hills
- Administrative Address: UCLA Hematology/Oncology - Los Angeles
- UCLA Hematology/Oncology - Los Angeles
- UCSD Medical Center - Bankers Hill - San Diego
- UC San Diego Medical Center - Hillcrest - San Diego
- UCLA Hematology/Oncology - San Luis Obispo - San Luis Obispo
- UCLA Hematology/Oncology- Santa Barbara - Santa Barbara
- UCLA Hematology/Oncology - Santa Monica - Santa Monica
- UCLA Hematology/Oncology Parkside - Santa Monica
Arizona
- Mayo Clinic Hospital - Phoenix
- Mayo Clinic - Scottsdale
Arkansas
- Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 654 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2027-09-28 |
| Phase | Phase 3 |
What the registry record for NCT05132582 still lists
NCT05132582 is an interventional study that assigns participants to a tested intervention. The registered 654 participants enrollment target is mid-sized for trials with a published cap, above the 224-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (192% higher).
The record links to 1 condition, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.
NCT05132582 names 20 study sites across 3 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT05132582 about?
NCT05132582 is a clinical study titled "A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer". 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 participa...
What is the current status of trial NCT05132582?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 654 participants. The study started on 2022-03-07. Estimated completion is 2027-09-28.
What conditions does trial NCT05132582 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer.
What interventions are being tested in trial NCT05132582?
The interventions under investigation include: Trastuzumab (DRUG), Placebo (DRUG), Tucatinib (DRUG), Pertuzumab (DRUG), Combination product: Trastuzumab + Pertuzumab (DRUG).
Who is sponsoring clinical trial NCT05132582?
This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05132582 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-positive Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05132582's enrollment target sits among peer trials
654 3rd of 58 higher than 56 of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer
RECRUITING · Phase 3
-
A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
ACTIVE NOT RECRUITING · Phase 3
-
Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer
ACTIVE NOT RECRUITING · Phase 3
-
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
RECRUITING · Phase 2
-
TRUDI: TDXD+Durva in HER2+/Low IBC
RECRUITING · Phase 2
-
HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07145515 · 655 participants · NA
Enhancing Heart Allograft Function With the OCS Heart System Trial
- NCT05407129 · 656 participants · NA
Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences
- NCT06127199 · 656 participants · NA
Contraceptive Efficacy Study of Ovaprene
- NCT06287346 · 652 participants
5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI