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

Conditions

• Metastatic HER2-positive Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zanidatamab — DRUG
  Administered by intravenous infusion
• Trastuzumab — DRUG
  Administered by intravenous infusion
• Eribulin — DRUG
  Administered by intravenous infusion
• Vinorelbine — DRUG
  Administered by intravenous infusion
• Gemcitabine — DRUG
  Administered by intravenous infusion
• Capecitabine — DRUG
  Given orally

Study Details

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.

Key Dates

Start date

Aug 13, 2024

Status verified

Feb 2026

Primary completion

Apr 28, 2028

Completion

Oct 18, 2030

Study Design

Enrollment

550 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Zanidatamab plus physician's choice of chemotherapy
  Participants with HER2-positive metastatic breast cancer (mBC) who have progressed on, or are intolerant to, previous T-DXd treatment will be randomized to receive intravenous infusion of zanidatamab plus physician's choice of chemotherapy (eribulin, or vinorelbine, or gemcitabine, or capecitabine).
• Active Comparator: Trastuzumab plus physician's choice of chemotherapy
  Participants with HER2-positive metastatic breast cancer (mBC) who have progressed on, or are intolerant to, previous T-DXd treatment will be randomized to receive intravenous infusion of trastuzumab plus physician's choice of chemotherapy (eribulin, or gemcitabine, or vinorelbine, or capecitabine).

Primary Outcome Measure

Progression-free Survival (PFS) Per RECIST Version 1.1 As Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Until disease progression or death, up to approximately 44 months ]

Central Contacts

• Clinical Trial Disclosure & Transparency
  215-832-3750
  [email protected]

Locations (48)

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