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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJazz Pharmaceuticals

About this trial

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.

Eligibility criteria

Qualifiers

Is 18 years of age or of the legal adult age per local standard at the time of signing the informed consent.

Has histologically confirmed HER2-positive breast cancer according to ASCO-CAP Guidelines as evaluated by a sponsor-designated central laboratory

Participants with unresectable or metastatic HER2 positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.

Must have received at least 2 lines of HER2-directed therapy for their metastatic disease.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Zanidatamab
  • Trastuzumab
  • Eribulin
  • Vinorelbine
  • Gemcitabine
  • Capecitabine

Treatment groups

550 Participants
are divided into 2 treatment groups

Sponsors and collaborators