HER2CLIMB-05: NCT05132582: Phase 3: Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

First Posted	2021-11-24
Trial status	Active, not recruiting
Sponsor	Seagen, a wholly owned subsidiary of Pfizer
Abstract Presentation	Her2climb-05: a randomized, double-blind, phase 3 study of tucatinib versus placebo in combination with trastuzumab and pertuzumab as maintenance therapy for her2+ metastatic breast cancer December 10, 2025 Click here for details
Peer-reviewed journal publication	HER2CLIMB-05: A Phase III Study of Tucatinib Versus Placebo in Combination With Trastuzumab and Pertuzumab as First-Line Maintenance Therapy for HER2+ Metastatic Breast Cancer December 10, 2025 PUBMED JCO
Press Release	Adding Tucatinib to First-line Maintenance Therapy Delayed Disease Progression in HER2-positive Metastatic Breast Cancer in HER2CLIMB-05 Trial December 10, 2025 Presented at San Antonio Breast Cancer Symposium (SABCS) AACR SABC
FDA
NCCN

HER2CLIMB-05: NCT05132582: Phase 3: Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

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)

Intervention / Treatment:

Drug: Tucatinib

Drug: Trastuzumab

Drug: Pertuzumab

Drug: Combination product: Trastuzumab + Pertuzumab

Drug: Placebo

Other Study ID Numbers:

SGNTUC-028

C4251007 ( Other Identifier ) (OTHER: Alias Study Number)

2023-503826-37-00 ( Registry Identifier ) (REGISTRY: CTIS (EU))

ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT05132582