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Tucatinib
Source: Breast Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: April 25, 2025 · Captured 2026-09-09.
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Tucatinib is an oral TKI highly selective for the kinase domain of HER2 that minimally inhibits the epidermal growth factor receptor. A phase Ib trial in pretreated patients demonstrated activity when tucatinib was combined with trastuzumab and capecitabine.
Evidence (tucatinib):
The HER2CLIMB trial (NCT02614794) compared trastuzumab, capecitabine, and tucatinib with trastuzumab, capecitabine, and placebo in 632 patients who had previously been treated with trastuzumab, pertuzumab, and trastuzumab emtansine. Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients with and without brain metastases were included. The primary end point was PFS.[82][Level of evidence A1]
Source links and citations
The HER2CLIMB trial (NCT02614794) compared trastuzumab, capecitabine, and tucatinib with trastuzumab, capecitabine, and placebo in 632 patients who had previously been treated with trastuzumab, pertuzumab, and trastuzumab emtansine. Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients with and without brain metastases were included. The primary end point was PFS.[82][Level of evidence A1]
The median PFS was 7.8 months in the tucatinib combination group and 5.6 months in the placebo combination group (HR, 0.54; 95% CI, 0.42–0.71; P < .001)
The HER2CLIMB trial (NCT02614794) compared trastuzumab, capecitabine, and tucatinib with trastuzumab, capecitabine, and placebo in 632 patients who had previously been treated with trastuzumab, pertuzumab, and trastuzumab emtansine. Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients with and without brain metastases were included. The primary end point was PFS.[82][Level of evidence A1]
In an interim analysis conducted at the time of the PFS analysis, median OS was 21.9 months in the tucatinib combination group and 17.4 months in the placebo combination group (HR, 0.66; 95% CI, 0.50–0.88; P = .005)
The HER2CLIMB trial (NCT02614794) compared trastuzumab, capecitabine, and tucatinib with trastuzumab, capecitabine, and placebo in 632 patients who had previously been treated with trastuzumab, pertuzumab, and trastuzumab emtansine. Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients with and without brain metastases were included. The primary end point was PFS.[82][Level of evidence A1]
Patients with and without brain metastases benefited from the tucatinib combination.
The HER2CLIMB trial (NCT02614794) compared trastuzumab, capecitabine, and tucatinib with trastuzumab, capecitabine, and placebo in 632 patients who had previously been treated with trastuzumab, pertuzumab, and trastuzumab emtansine. Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients with and without brain metastases were included. The primary end point was PFS.[82][Level of evidence A1]
Grade 3 adverse events including diarrhea, palmar-plantar erythrodysesthesia syndrome, and elevated aminotransferase levels were more common in the tucatinib combination group but occurred in fewer than 15% of patients.
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Preserved source evidence · Not medical advice