Health TrialsbyHealthPanel

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

ConditionMetastatic 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: Zanidatamab plus physician's choice of chemotherapyExperimental treatment 5 interventions
Group B: Trastuzumab plus physician's choice of chemotherapyActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

Progression-free Survival (PFS) Per RECIST Version 1.1 As Assessed by Blinded Independent Central Review (BICR)

PFS is defined as the time in months from randomization to the date of first documented disease progression (as assessed by BICR according to RECIST v1.1) or death from any cause, whichever occurs first.

Time frame
Until disease progression or death, up to approximately 44 months

Secondary outcomes

1

Overall Survival (OS)

OS is defined as the time in months from randomization to the date of death due to any cause.

Time frame
Until death, up to approximately 80 months
2

Confirmed Objective Response Rate (ORR) Per RECIST Version 1.1, As Assessed by BICR

The BICR-assessed confirmed ORR is defined as the proportion of participants who had a best overall response of BICR-assessed Complete Response (CR) or Partial Response (PR) after randomization.

Time frame
Until disease progression or death, up to approximately 44 months
3

Duration of Response (DOR) Per RECIST Version 1.1, As Assessed by BICR

BICR-assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) as assessed by BICR per RECIST v1.1 or death from any cause.

Time frame
Until disease progression or death, up to approximately 44 months
4

PFS Per RECIST Version 1.1, As Assessed By Investigator

Investigator-assessed PFS is defined as the time in months from randomization to the date of first documented disease progression (as assessed by investigator according to RECIST v1.1) or death from any cause, whichever occurs first

Time frame
Until disease progression or death, up to approximately 44 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jazz Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
Apply now