OncRef

Clinical Trial: NCT03281954

Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:NSABP Foundation Inc
Information Provided By:NSABP Foundation Inc
Last Update Posted:2024-04-08

Study Overview

Brief Summary

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.

Official Title

A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo

Conditions

Triple Negative Breast Cancer

Intervention / Treatment

  • Drug: Placebo
  • Drug: Atezolizumab

Other Study ID Numbers

  • NSABP B-59/GBG 96-GeparDouze
  • 2017-002771-25
  • MO39875
  • 2017

Start Date (Actual)

2017-12-19

Primary Completion Date (Estimated)

2024-12-31

Study Completion Date (Estimated)

2027-11-30

Enrollment (Actual)

1550

Study Type

Interventional

Phase

Phase 3