Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 24, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT04224272). This is a study registration, not published results. Lead sponsor: Jazz Pharmaceuticals. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 51 participants (ACTUAL). Conditions: HER2+/HR+ Breast Cancer. Interventions: DRUG: ZW25 (Zanidatamab); DRUG: Palbociclib; DRUG: Fulvestrant. Primary outcome measures: Number of Participants With Dose-Limiting Toxicities , Cycle 1 Day 1 to Day 28 (each cycle is 28 days); Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events , From the start of dosing of any study drug up until 30 days after last study dose, up to approximately 5 years 20 days.; Progression-free Survival 6 , 6 months from first dose of all study drugs to the date of documented disease progression or death. Brief summary: This is a multicenter, Phase 2a, open-label, 2-part study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) in combination with palbociclib plus fulvestrant. Eligible patients include those with locally advanced (unresectable) and/or metastatic human epidermal growth factor receptor 2 (HER2)-positive, hormone receptor (HR)-positive breast cancer.