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A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

Study acronym: HER2CLIMB-05
StatusActive, Not Recruiting
PhasePhase 3
Started2022-03-07
View on ClinicalTrials.gov ↗
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.

Amendment history 1 change detected by DataLookout

2026-04-21
Trial sites expanded: 303 → 307 locations
Trial Details
NCT Number NCT05132582
Lead Sponsor Seagen, a wholly owned subsidiary of Pfizer
Conditions HER2 Positive Breast Cancer
Enrollment 654 participants
Start Date 2022-03-07
Primary Completion 2025-09-05 (estimated)
Study Completion 2027-09-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-22