NCT04224272Phase 2Completed

Phase 2a Study of ZW25 in Combination With Palbociclib Plus Fulvestrant

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-04-28Actual

Enrollment · participants51Actual

Source updated2026-09-24Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

HER2+/HR+ Breast Cancer

Treatments or interventions studied

ZW25 (Zanidatamab)Drug
PalbociclibDrug
FulvestrantDrug

Primary outcomes · main study measures

Read the study measures

measure: Number of Participants With Dose-Limiting Toxicities; description: Dose-limiting toxicities, defined using NCI CTCAE version 5.0, are events that 1) occur following administration of ZW25, palbociclib, and fulvestrant; and 2) meet the criteria as specified in the protocol.; timeFrame: Cycle 1 Day 1 to Day 28 (each cycle is 28 days); measure: Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events; description: A treatment-emergent adverse event occurs after the start of study treatment and is defined as any unfavorable or unintended symptom, sign, or disease (including abnormal lab) temporally associated with the use of treatment that may or may not be considered related to treatment. TEAEs were coded using MedDRA v24.0.; timeFrame: From the start of dosing of any study drug up until 30 days after last study dose, up to approximately 5 years 20 days.; measure: Progression-free Survival 6; description: The progression-free survival at 6 months (PFS6) is a binary endpoint variable based on the progression-free survival (PFS) time, defined as the proportion of participants having PFS time greater than or equal to 24 weeks (168 days).; timeFrame: 6 months from first dose of all study drugs to the date of documented disease progression or death

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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