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Clinical trial · no report yet · Phase 3

IMpassion031

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

  • NCT03197935 ↗
  • Completed
  • Hoffmann-La Roche
  • 27 commentary sources found
  • Standard

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

ChannelFound
YouTube10
Podcasts9
X threads8

The trial

ClinicalTrials.gov
Official title
A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer
Phase
Phase 3
Status
Completed
Conditions
Triple-negative Breast Cancer
Interventions
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody; Placebo; Nab-paclitaxel; Doxorubicin; Cyclophosphamide; Filgrastim; Pegfilgrastim
Arms
  • Atezolizumab and Chemotherapy · Experimental
  • Placebo and Chemotherapy · Placebo comparator
Enrollment
333
Primary outcomes
  • Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population
  • Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System
Sponsor
Hoffmann-La Roche
Start
Jul 24, 2017
Primary completion
Apr 3, 2020
Results posted
Yes
Registry record
NCT03197935 · updated Oct 26, 2023

Publications

linked from the registry
  • Mittendorf EA, Assaf ZJ, Harbeck N, Zhang H, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Qamra A, Dieterich M, Xu Y, Liste-Hermoso M, Shearer-Kang E, Molinero L, Chui SY, Barrios CH. Peri-operative atezolizumab in early-stage triple-negative breast cancer: final results and ctDNA analyses from the randomized phase 3 IMpassion031 trial. Nat Med. 2025 Jul;31(7):2397-2404. doi: 10.1038/s41591-025-03725-4. Epub 2025 Jun 4. PubMed 40467898
  • Mittendorf EA, Zhang H, Barrios CH, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Penault-Llorca F, Patel S, Duc AN, Liste-Hermoso M, Maiya V, Molinero L, Chui SY, Harbeck N. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet. 2020 Oct 10;396(10257):1090-1100. doi: 10.1016/S0140-6736(20)31953-X. Epub 2020 Sep 20. PubMed 32966830
  • Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25. PubMed 32450725