A Phase 3 Study of Chemotherapy Plus Either Zanidatamab or Trastuzumab in People With Breast Cancer

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Full Title

A Phase 3, Randomized, Open-Label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination with Physician’s Choice Chemotherapy Compared to Trastuzumab in Combination with Physician’s Choice Chemotherapy for the Treatment of Participants with Metastatic HER2-Positive Breast Cancer Who Have Progressed on, or are Intolerant to, Previous Trastuzumab Deruxtecan Treatment

Purpose

Researchers are comparing two different treatments for breast cancer that metastasized (spread) and makes high levels of the HER2 protein. The people in this study have metastatic HER2-positive breast cancer that keeps growing after trastuzumab deruxtecan (T-DXd). Or they may have had bad side effects from this drug and had to stop taking it.

If you take part in this study, you will be randomly assigned to get one of these treatments:

  • Zanidatamab plus standard chemotherapy (eribulin, gemcitabine, vinorelbine, or capecitabine)
  • Trastuzumab plus standard chemotherapy

Zanidatamab and trastuzumab both target and block HER2, but in different ways. The HER2 protein plays a role in the growth of breast cancer cells. Both drugs are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have HER2-positive metastatic breast cancer that cannot be successfully treated with T-DXd.
  • Have recovered from the serious side effects of prior therapies before getting the study treatment.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Joshua Drago’s office at 646-888-6971.

Protocol

25-098

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT06435429