A Phase III Study of Chemotherapy with or without Atezolizumab Immunotherapy in Patients with Triple-Negative Breast Cancer Whose Tumor was Removed by Surgery

Full Title

A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti-Pd-L1 Antibody) in Combination with Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients with Operable Triple-Negative Breast Cancer

Purpose

The immunotherapy drug atezolizumab is already approved for use in combination with nab-paclitaxel chemotherapy in patients with metastatic triple-negative breast cancer (TNBC, a form of the disease in which the tumor lacks receptors for estrogen, progesterone, and HER2) that is positive for the PDL1 protein. In this study, researchers want to see if this combination therapy is effective in women with TNBC that has been surgically removed and has not spread.

Atezolizumab works by blocking a protein that cancer cells use to avoid detection by the immune system, thereby boosting the power of the immune system to find and kill cancer cells. In this study, patients will be randomly assigned to one of these two treatments:

  • Atezolizumab plus chemotherapy (paclitaxel followed by cyclophosphamide with doxorubicin)
  • Chemotherapy alone (paclitaxel followed by cyclophosphamide with doxorubicin)

All medications used in this study 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 stage II or III TNBC that was surgically removed within 8 weeks of joining the study.
  • Patients may not have had prior treatment other than surgery for the current breast cancer.
  • 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. Tiffany A. Traina at 646-888-5209.

Protocol

18-543

Phase

III

Investigator

Co-Investigators

Diseases