HER2-positive Breast Cancer Clinical Trial
Official title:
Tucatinib in Combination With Oral Etoposide (VP16) - Trastuzumab in Patients With Metastatic HER2+ Breast Cancer After Progression Under Tucatinib-Capecitabine-Trastuzumab or Toxicity Related to Capecitabine: a Multicenter Phase II
This is an open-label, multicenter, phase II study to evaluate the efficacy, safety, tolerability, pharmacokinetics of the combination of tucatinib-Oral VP16-trastuzumab in patients with HER2-positive metastatic breast cancer (HER2+ MBC) after progression on tucatinib-capecitabine-trastuzumab or capecitabine-related toxicity.
This is an open-label, multicenter, phase II study to evaluate the efficacy, safety, tolerability, pharmacokinetics of the combination of tucatinib-Oral VP16-trastuzumab in patients with HER2-positive metastatic breast cancer (HER2+ MBC) after progression on tucatinib-capecitabine-trastuzumab or capecitabine-related toxicity. The study has two sequential parts: - Part 1 is a safety run-in part evaluating the safety of the combination to confirm the recommended dose; - Part 2 will evaluate the efficacy of the combination at the recommended dose. Both parts will include patients with HER2 positive metastatic breast cancer. In part 1, a D-dose is evaluated; only in case of unacceptable toxicity at the D-dose, a D-1 dose will be investigated. In part 2, patients will be treated with oral VP16 at the dose recommended in part 1. Dose reductions will be allowed on subsequent cycles in case of toxicity. All enrolled patients will receive the combination of tucatinib, oral VP16, trastuzumab until disease progression, unacceptable toxicity, and withdrawal of patient consent, investigator decision, and loss to follow-up, death, patient non-compliance, or discontinuation of the study by the sponsor. Tumor assessments should be performed according to RECIST v1.1 criteria at baseline and every 6 weeks (± 7 days) for the first 24 weeks, then every 9 weeks (± 7 days) until documented disease progression, withdrawal of consent, or death. ;
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