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Table 2 Summary of clinical studies evaluating tucatinib combination approaches in HER2+ metastatic breast cancer patients with brain metastasis

From: The efficacy of tucatinib-based therapeutic approaches for HER2-positive breast cancer

Treatment(s)

Parameter(s)

Study design and finding(s)

Tucatinib + trastuzumab + capecitabine [47]

OS

To evaluate safety. The OS was 20.7 months with the tucatinib-combination

Tucatinib + T-DMI [77]

mPFS

Phase I dose-escalation study to evaluate effect. The mPFS was 8.2 months

Tucatinib + trastuzumab [78]

MTD

Phase I dose-escalation study to evaluate response. The combination therapy was tolerable and effective in HER2+ breast cancer patients having brain metastases

Tucatinib + capecitabine, tucatinib + trastuzumab, tucatinib + capecitabine + trastuzumab [46]

mPFS

Phase I dose-escalation study to evaluate response. ORR of tucatinib + capecitabine was 83%, tucatinib + trastuzumab was 40%, and tucatinib + capecitabine + trastuzumab was 61%. The mPFS of the triple combination in patients with no brain metastasis was 7.8 months; however, it was 6.7 months in patients with brain metastasis

Tucatinib + trastuzumab + capecitabine [79]

OS

Phase II study to evaluate safety and efficacy. The median OS was 11.9 months and the median time to CNS progression 6.9 months

  1. HER2+ HER2-positive, OS overall survival, T-DMI ado-trastuzumab emtansine, mPFS median progression-free survival, MTD maximum tolerable dose, ORR objective response rate, SD stable disease, CNS central nervous system