First Patient Dosed in Phase 3 Trial of Tucatinib-Kadcyla Combo for Advanced HER2-Positive Breast Cancer

First Patient Dosed in Phase 3 Trial of Tucatinib-Kadcyla Combo for Advanced HER2-Positive Breast Cancer
A Phase 3 trial exploring a combination of Seattle Genetics' tucatinib plus standard Kadcyla (ado-trastuzumab emtansine) in people with advanced HER2-positive breast cancer has dosed its first participant, the company announced. The trial — called HER2CLIMB-02 (NCT03975647) — is enrolling up to 460 adult patients with metastatic or inoperable, locally advanced disease who received prior treatment with a taxane chemotherapy and trastuzumab. The trial's results are expected to be included in Seattle Genetics' application seeking approval for tucatinib in the U.S. for this indication. “We are building a comprehensive strategy for tucatinib in combination with other medicines across a range of HER2-positive cancers,” Roger Dansey, MD, chief medical officer at Seattle Genetics, said in a news release. “We are pleased to advance this tucatinib clinical trial with the vision of improving combination outcomes for patients with HER2-positive metastatic breast cancer who receive T-DM1,” he said. “This trial has the potential to support tucatinib use in earlier lines of therapy.” When breast cancers are driven by the protein
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