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 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 227-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (188% higher). The trial reports 20 study locations across 3 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05132582
The ClinicalTrials.gov registry entry for NCT05132582 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 654 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 227-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (188% higher). The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 28 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 3 distinct geographic areas - top geographies include 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.
-
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
-
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
-
A Phase 1/1b Study of IAM1363 in HER2 Cancers
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.