HER2CLIMB: NCT02614794: Phase 3: Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

First Posted	2015-11-25
Trial status	Completed
Sponsor	Seagen Inc.
Abstract Presentation	Phase III HER2CLIMB Trial Yields Positive Data in Patients With HER2-Positive Metastatic Breast Cancer and Brain Metastasis Late-breaking oral presentation, San Antonio Breast Cancer Symposium 2019; results subsequently published in NEJM (2020). Click here for details
Peer-reviewed journal publication	Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer December 11, 2019 - N Engl J Med PUBMED NEJM Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial J Clin Oncol . 2020 Aug 10 PUBMED JCO Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis ESMO - Ann Oncol. 2022 Mar PUBMED ANNALS OF ONCOLOGY
Press Release	Seattle Genetics Announces Positive Tucatinib HER2CLIMB Trial Results in Locally Advanced or Metastatic HER2-Positive Breast Cancer Presented at 2019 SABCS and Published in the New England Journal of Medicine December 11, 2019 Click here for details
FDA	FDA approves tucatinib for patients with HER2-positive metastatic breast cancer April 17, 2020 Click here for details
NCCN	BRS174

HER2CLIMB: NCT02614794: Phase 3: Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer (HER2CLIMB)

Official Title:

Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma

Intervention / Treatment:

Drug: tucatinib

Drug: capecitabine

Drug: trastuzumab

Drug: placebo

Other Study ID Numbers:

ONT-380-206

2015-002801-12 ( EudraCT Number )

ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT02614794