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A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer

NCT06435429 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2026-02-10

No results posted yet for this study

Summary

The efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.

Conditions

  • Metastatic HER2-positive Breast Cancer

Interventions

DRUG

Zanidatamab

Administered by intravenous infusion

DRUG

Trastuzumab

Administered by intravenous infusion

DRUG

Eribulin

Administered by intravenous infusion

DRUG

Vinorelbine

Administered by intravenous infusion

DRUG

Gemcitabine

Administered by intravenous infusion

DRUG

Capecitabine

Given orally

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-13
Primary Completion
2028-04-28
Completion
2030-10-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Poland
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06435429 on ClinicalTrials.gov