Phase 2 Trial of Triple Combo in Treating Advanced Breast Cancer Opening, Zymeworks Says

Phase 2 Trial of Triple Combo in Treating Advanced Breast Cancer Opening, Zymeworks Says
Zymeworks announced the start of a Phase 2 trial examining its experimental cancer treatment ZW25, in combination with Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) and the hormone therapy Faslodex (fulvestrant), in people with advanced breast cancer. An agreement with Pfizer to make Ibrance available to the Zymeworks-sponsored study helped to move it forward. The trial (NCT04224272) is recruiting up to 76 patients with locally advanced breast cancer who received prior treatment or with metastatic breast cancer. The cancer must also be positive for a hormone receptor (HR) and for the HER2 protein. The open-label, two-part trial is now enrolling at South Texas Accelerated Research Therapeutics in San Antonio, with plans to expand to additional sites in the U.S., Canada, and Spain. Information is available here. Investigators in the study's first part will evaluate the tolerability and safety of ZW25, in combination with Ibrance and Faslodex, and confirm the recommended dosages of ZW25 and Ibrance. That will be achieved by measuring the number of adverse events, dose-limiting toxicities, and lab abnormalities reported in treated patients. Evidence of early efficacy is the goal of the second part. Here, investigators will determine the anti-tumor activity of the combination therapy at the established doses by measuring the proportion of patients alive and without disease progression at six months. Secondary efficacy measures include the proportion of patients who respond to treatment, duration of responses, and progression-free survival, or the length of time that patients go without disease worsening, both during and after the treatment. Patients in the trial will receive ZW25 intravenously (into the bloodstream) every two weeks, oral Ibrance once
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