HER2CLIMB
Research type
Research Study
Full 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\n(HER2CLIMB)
IRAS ID
220300
Contact name
Andrew Wardley
Contact email
Sponsor organisation
Cascadian Therapeutics Inc
Eudract number
2015-002801-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 1 months, 0 days
Research 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 in patients with locally advanced or metastatic breast cancer. The study is in patients expressing a particular gene, HER2. Patients will have a tumour slide sent for central testing prior to joining the study.\n\nThe primary purpose of this research study will be to compare the time it takes for tumors to grow based on CT or MRI scans in patients who receive tucatinib compared to placebo. All patients will receive capecitabine and trastuzumab.\n\nEligible patients will be randomly assigned 2:1 to receive either tucatinib (600mg total daily dose in tablet form) or placebo. The study is double blinded and therefore neither patients or study doctors will know what treatment patients are assigned to receive.\n\nPatients will attend a number of clinic visits in which procedures will be conducted in order to test the safety and efficacy of tucatinib. Study procedures include HER2 testing, demographics, medical/oncology history, vital signs, 12 lead ECG, blood tests, urinalysis and CT/MRI scans as appropriate.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0162
Date of REC Opinion
21 Mar 2017
REC opinion
Favourable Opinion