A Phase III Study of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab Immunotherapy or Placebo as Initial Therapy for HER2-Positive Metastatic Breast Cancer

Share
Print

Full Title

A Randomized, Double-Blind, Phase III Trial of Taxane/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer (NRG-BR004) (CIRB)

Purpose

Chemotherapy combined with trastuzumab and pertuzumab is a standard therapy for patients with HER2-positive metastatic breast cancer. In this study, researchers want to see if adding the immunotherapy drug atezolizumab to this treatment makes it more effective. Atezolizumab works by taking the brakes off the immune response, allowing the immune system to detect and destroy cancer cells. Its use for HER2-positive breast cancer is considered investigational.

Patients in this study will be randomly assigned to receive paclitaxel, trastuzumab, and pertuzumab with either atezolizumab or a placebo. All treatments are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have HER2-positive metastatic breast cancer and may not have received treatment for advanced disease.
  • At least 6 months must pass between the completion of previous therapy for nonmetastatic disease and receipt of the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Chau Dang at 914-367-7181.

Protocol

20-433

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

Diseases