The HER2CLIMB trial was a randomized study that tested the triplet combination of tucatinib, capecitabine and trastuzumab, versus placebo in combination with trastuzumab-capecitabine, in patients who have HER2-positive, pretreated, metastatic breast cancer. Importantly, the trial, unlike really all other registration trials in breast cancer, until quite recently, included patients, not only with stable treated brain metastases, but also those with progressive or active brain metastases...
The HER2CLIMB trial was a randomized study that tested the triplet combination of tucatinib, capecitabine and trastuzumab, versus placebo in combination with trastuzumab-capecitabine, in patients who have HER2-positive, pretreated, metastatic breast cancer. Importantly, the trial, unlike really all other registration trials in breast cancer, until quite recently, included patients, not only with stable treated brain metastases, but also those with progressive or active brain metastases. And almost half of the patients included in HER2CLIMB had brain metastases at baseline.
The study showed that for the overall study population of all patients combined, there was an improvement in progression-free survival and overall survival, but in addition showed that for the subset of patients with brain metastases, there were substantial improvements in progression-free survival, overall survival, CNS progression-free survival and CNS objective response. And these improvements extended to the group of patients who had active brain metastases at baseline.