Study study type PathologyT1T0Patientssample sizesROB Results

la/mBC - HER2 positive - 2nd Line (L2) breast cancer - HER2-positive la/mBC - HER2 positive la/mBC - HER2 positive - 2nd Line (L2)

versus trastuzumab plus capecitabine
tucatinib plus trastuzumab plus capecitabine
HER2CLIMB, 2020
  NCT02614794
RCTla/mBC - HER2 positive - 2nd Line (L2)tucatinib plus trastuzumab plus capecitabineplacebo plus trastuzumab plus capecitabinePatients with HER2-positive advanced breast cancer, had previously been treated with trastuzumab, pertuzumab, and trastuzumab emtansine. Patients with brain metastases were included unless they were in need of immediate local intervention (enrolled subsequently), or with untreated brain metastases larger than 2 cm in diameter could be enrolled with approval from the medical monitor.410 / 202low
conclusif
  • demonstrated 34 % decrease in deaths (OS) (PE)
  • demonstrated 46 % decrease in progression or deaths (PFS) (PE)
HER2CLIMB (patients with brain metastases), 2020
  NCT02614794
RCTla/mBC - HER2 positive - 2nd Line (L2)tucatinib plus trastuzumab plus capecitabineplacebo plus trastuzumab plus capecitabinePatients with HER2-positive advanced breast cancer, had previously been treated with trastuzumab, pertuzumab, and trastuzumab emtansine. Patients with brain metastases were included unless they were in need of immediate local intervention (enrolled subsequently), or with untreated brain metastases larger than 2 cm in diameter could be enrolled with approval from the medical monitor.198 / 93low
conclusif
  • demonstrated 52 % decrease in progression or deaths (PFS) (PE)