Evidence map›Paper›PMID 40467898›Full record

Trial reportNature medicine2025

Peri-operative atezolizumab in early-stage triple-negative breast cancer: final results and ctDNA analyses from the randomized phase 3 IMpassion031 trial.

Elizabeth A Mittendorf, Zoe June Assaf, Nadia Harbeck, Hong Zhang, Shigehira Saji, Kyung Hae Jung, Roberto Hegg, Andreas Koehler, Joohyuk Sohn, Hiroji Iwata and 11 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Nature medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03197935 (A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03197935 phase3completednot on this map

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

TypeinterventionalSponsorHoffmann-La RocheRan2017 to 2022Enrolled333ConditionsTriple-negative Breast CancerArmsAtezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Placebo, Nab-paclitaxel, Doxorubicin, Cyclophosphamide
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Tumor-Infiltrating Lymphocytes as a Predictor of Adjuvant Avelumab Efficacy in Patients with High-risk Triple-Negative Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
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  6. Article
  7. Article
  8. Review
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  11. Ultrasound-activated RuORSC advances · 2026
    Article
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  16. Article
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  18. Current perspectives on circulating tumor DNA in breast cancer: a narrative review.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026
    Review
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Elizabeth A MittendorfDepartment of Surgery, Division of Breast Surgery, Brigham and Women's Hospital, Boston, MA, USA. emittendorf@bwh.harvard.edu.ORCID http://orcid.org/0000-0002-9762-8536
Zoe June AssafOncology Biomarker Development, Genentech, South San Francisco, CA, USA.ORCID http://orcid.org/0000-0002-3469-6697
Nadia HarbeckDepartment of Gynecology and Obstetrics and Comprehensive Cancer Center Munich, Breast Center, Ludwig-Maximilians-University Hospital, Munich, Germany.ORCID http://orcid.org/0000-0002-9744-7372
Hong ZhangMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Shigehira SajiFukushima Medical University, Fukushima, Japan.
Kyung Hae JungAsan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-1580-7224
Roberto HeggUniversity of São Paulo, São Paulo, Brazil.
Andreas KoehlerGemeinschaftspraxis für Haematologie und Onkologie Langen, Langen, Germany.
Joohyuk SohnYonsei Cancer Center, Yonsei University Health System, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-2303-2764
Hiroji IwataAichi Cancer Center Hospital, Nagoya, Japan.
Melinda L TelliDepartment of Medicine, Stanford University School of Medicine, Stanford, CA, USA.ORCID http://orcid.org/0000-0001-7993-1235
Cristiano FerrarioJewish General Hospital-McGill University, Montréal, Quebec, Canada.
Kevin PunieDepartment of General Medical Oncology and Multidisciplinary Breast Centre, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium.
Aditi QamraData and Statistical Sciences-Oncology, Hoffmann-La Roche Limited, Mississauga, Ontario, Canada.
Max DieterichProduct Development Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.ORCID http://orcid.org/0000-0002-8748-3396
Yun XuData and Statistical Sciences-Oncology, Hoffmann-La Roche Limited, Mississauga, Ontario, Canada.
Mario Liste-HermosoProduct Development Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Esther Shearer-KangProduct Development Safety, Genentech, South San Francisco, CA, USA.
Luciana MolineroOncology Biomarker Development, Genentech, South San Francisco, CA, USA.
Stephen Y ChuiProduct Development Oncology, Genentech, South San Francisco, CA, USA.
Carlos H BarriosLatin American Cooperative Oncology Group (LACOG), Oncoclínicas, Porto Alegre, Brazil.ORCID http://orcid.org/0000-0001-6021-667X

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748Roche (F. Hoffmann-La Roche Ltd) N/ARoche (F. Hoffmann-La Roche Ltd) NA
6 · The paper itself

Abstract

Previously published results demonstrated that the randomized phase 3 IMpassion031 trial met its primary objective: adding atezolizumab to neoadjuvant chemotherapy significantly improved pathologic complete response (pCR) rate in patients with stage II/III triple-negative breast cancer (TNBC). Here we report the prespecified final analysis of the secondary endpoints with 3 years' follow-up, together with exploratory analyses of circulating tumor (ct)DNA. Patients with previously untreated stage II/III TNBC enrolled in 75 academic and community sites in 13 countries were randomized 1:1 to receive neoadjuvant chemotherapy with either peri-operative atezolizumab (n = 165) or preoperative placebo (n = 168). Descriptive secondary endpoints included event-free, disease-free and overall survival. Long-term outcomes favored the atezolizumab group (event-free survival hazard ratio (HR), 0.76; 95% confidence interval (CI), 0.47-1.21; disease-free survival HR, 0.76; 95% CI, 0.44-1.30; overall survival HR, 0.56; 95% CI, 0.30-1.04). Among patients without pCR, 14 of 70 (20%) atezolizumab-treated and 33 of 99 (33%) placebo-treated patients received additional adjuvant therapy, frequently capecitabine. In exploratory biomarker analyses, patients with baseline ctDNA-negative status (6%) had excellent long-term outcomes. Most patients (87%) had cleared ctDNA at surgery. ctDNA-positive status at surgery identified a subset of non-pCR patients with poorest prognosis. Long-term safety was consistent with primary results. These data show that adding atezolizumab to chemotherapy for stage II/III TNBC is associated with favorable long-term outcomes, and ctDNA dynamics provide prognostic value beyond pCR. ClinicalTrials.gov identifier: NCT03197935 .

Indexed as

Antibodies, Monoclonal, HumanizedCirculating Tumor DNATriple Negative Breast NeoplasmsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalFemaleHumansMiddle AgedNeoadjuvant TherapyNeoplasm StagingTreatment OutcomeAntibodies, Monoclonal, HumanizedatezolizumabCirculating Tumor DNA

Identifiers

PMID40467898
PMCPMC12283416

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.