Clinical Trials Search
Clinical Trial 19340
Cancer Type: Breast
Interventions:Herceptin (Trastuzumab); Not Applicable; Placebo; Trastuzumab; Tucatinib; Xeloda (capecitabine); capecitabine; rhuMAb HER2 (Trastuzumab)
Study Type: Treatment
Phase of Study: Phase II
Investigators:
- Hatem Soliman
Study 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 (HER2CLIMB)
Summary
The purpose of this study is to assess the effect of tucatinib vs. placebo in combination with capecitabine and trastuzumab on progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on independent central radiology review.
Objective
Primary Objective: To assess the effect of tucatinib vs. placebo in combination with capecitabine and trastuzumab on progression-free survival (PFS) per RECIST 1.1 based on independent central review