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

Short Title: Empowher


Enrollment Status: Not yet recruiting

NCT #: NCT06435429

Specialty Area: Oncology

Condition Studied: Metastatic HER2-positive Breast Cancer

Age Groups: Adult; Older Adult

Phase: III


Study Information

Summary / Purpose

To study treatment options for people with HER2-positive metastatic breast cancer whose cancer has grown or could not be tolerated after prior treatment. This study is comparing two HER2-targeted medications to understand how well they work and how safe they are in this setting. The goal of the study is to determine whether one treatment may better control the cancer after previous therapy has stopped working.

Study Type: Interventional
Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:
  • Adults 18+ years of age
  • Diagnosed with metastatic HER2-positive breast cancer that has worsened on or cannot tolerate prior trastuzumab deruxtecan
  • Able to receive one of the allowed chemotherapy options

What's Involved

Participation in the study will include:
  • Random assignment to receive either an investigational HER2-targeted antibody called zanidatamab plus a chemotherapy of the doctor’s choice or standard HER2 therapy (trastuzumab) plus chemotherapy
  • Regular clinic visits for treatment, monitoring, and safety assessments

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.

ER Wait Times

How are wait times calculated?

Our estimated ER wait times reflect the average time from check-in to being seen by a medical professional during triage, where patients are prioritized based on the severity of their condition.

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