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Monoclonal Antibodies

Zanidatamab vs Trastuzumab for Breast Cancer

Phase 3

Recruiting

Research Sponsored by Jazz Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until death, up to approximately 80 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test a new drug called zanidatamab in combination with chemotherapy to see if it is better than the current standard treatment using trastuzumab and chemotherapy for patients with

Who is the study for?

This trial is for adults with HER2-positive breast cancer that's spread and who've had issues with a previous treatment called T-DXd. They need to have measurable cancer growth, be expected to live at least 6 more months, and their body functions (like blood cells, liver, kidneys) must meet certain levels.

What is being tested?

The study compares Zanidatamab plus a chemotherapy chosen by the doctor against Trastuzumab with the same chemo options. It aims to see which combination is safer and works better for patients whose cancer has worsened after T-DXd treatment.

What are the potential side effects?

Possible side effects include reactions related to infusion of the drugs, impact on organ function like heart or lungs from Zanidatamab or Trastuzumab, as well as typical chemo side effects such as nausea, fatigue, low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is HER2-positive, confirmed by a specialized lab.

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My HER2 positive breast cancer cannot be surgically removed and has worsened despite previous treatment.

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I can be treated with eribulin, gemcitabine, vinorelbine, or capecitabine.

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My kidneys are functioning well enough, with a creatinine clearance rate of 30 mL/min or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until death, up to approximately 80 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until death, up to approximately 80 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and until death, up to approximately 80 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Confirmed ORR Per RECIST Version 1.1, As Assessed By Investigator

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

DOR Per RECIST Version 1.1, As Assessed By Investigator

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Zanidatamab plus physician's choice of chemotherapyExperimental Treatment5 Interventions

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).

Group II: Trastuzumab plus physician's choice of chemotherapyActive Control5 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eribulin

2012

Completed Phase 3

~2740

Vinorelbine

2013

Completed Phase 4

~2190