NCT03281954

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

Active, enrolled Phase 3 Last updated 8 April 2024

What this trial tests

Phase 3 trial testing Placebo in Triple Negative Breast Cancer in 1,550 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

19 December 2017

Primary endpoint
31 December 2024

30 November 2027

Quick facts

Lead sponsor	NSABP Foundation Inc
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	1,550
Start date	19 December 2017
Primary completion	31 December 2024
Estimated completion	30 November 2027
Sites	217 locations across Canada, United States

Drugs / interventions tested

• Placebo
• Atezolizumab (atezolizumab) — full drug profile →

Conditions studied

• Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →

Sponsor

NSABP Foundation Inc

Who can join

18 and older, any sex, with Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immune checkpoint inhibitors: recent progress and potential biomarkers.
   Darvin P, Toor SM, Sasidharan Nair V, Elkord E. · · 2018 · cited 1495× · PMID 30546008 · DOI 10.1038/s12276-018-0191-1
2. Recent advances in therapeutic strategies for triple-negative breast cancer.
   Li Y, Zhang H, Merkher Y, Chen L, et al · · 2022 · cited 643× · PMID 36038913 · DOI 10.1186/s13045-022-01341-0
3. Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer.
   Ye F, Dewanjee S, Li Y, Jha NK, et al · · 2023 · cited 361× · PMID 37415164 · DOI 10.1186/s12943-023-01805-y
4. Triple‑negative breast cancer therapy: Current and future perspectives (Review).
   Won KA, Spruck C. · · 2020 · cited 351× · PMID 33174058 · DOI 10.3892/ijo.2020.5135
5. Current Landscape of Immunotherapy in Breast Cancer: A Review.
   Adams S, Gatti-Mays ME, Kalinsky K, Korde LA, et al · · 2019 · cited 297× · PMID 30973611 · DOI 10.1001/jamaoncol.2018.7147
6. Recent advances in triple negative breast cancer: the immunotherapy era.
   Marra A, Viale G, Curigliano G. · · 2019 · cited 260× · PMID 31068190 · DOI 10.1186/s12916-019-1326-5
7. Pembrolizumab and atezolizumab in triple-negative breast cancer.
   Kwapisz D. · · 2021 · cited 189× · PMID 33015734 · DOI 10.1007/s00262-020-02736-z
8. Heterogeneity of triple negative breast cancer: Current advances in subtyping and treatment implications.
   Asleh K, Riaz N, Nielsen TO. · · 2022 · cited 123× · PMID 36050786 · DOI 10.1186/s13046-022-02476-1