Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo
May 10, 2018
Alexander Hantel, MD
Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst
The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. (A placebo is a drug that looks like the study drug but contains no medication.) The usual chemotherapy in this study is paclitaxel (WP) and carboplatin followed by doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC). Usually, after neoadjuvant therapy and surgery for triple negative breast cancer, no additional treatment is given unless the cancer returns. This study will also look at continuing treatment after surgery with atezolizumab or the placebo. To be better, atezolizumab given with the neoadjuvant therapy should be better at: 1) decreasing the amount of tumor in the breast than the placebo given with the usual chemotherapy and 2) decreasing the chance of the cancer from returning after surgery.
Another purpose of this study is to test the good and bad effects of atezolizumab when added to the usual chemotherapy. Atezolizumab may keep your cancer from growing but it can also cause side effects.
Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
- ER-negative, PgR-negative, and HER2-negative
Clinical stage T2 or T3
- No excisional biopsy or lumpectomy performed prior to study entry.
FNA alone to diagnose the breast cancer.
- No definitive evidence of metastatic disease.
- No previous history of contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
- No previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
- No history of other cancers in the last 5 years except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin.
- No prior treatment for the currently diagnosed breast cancer prior to randomization.
- No previous therapy with anthracyclines or taxanes for any malignancy.
- No active or history of autoimmune disease or immune deficiency with limited exceptions.
Kathy Seymour, BSN