---
title: "Atezolizumab plus neoadjuvant chemotherapy in early triple-negative breast cancer: NSABP B-59/Gepa"
id: "nature-3-atezolizumab-in-early-triple-negative-breast-cancer-the-randomized-phase-3"
canonical_url: "https://medichelpline.com/clinical-feed/nature-3-atezolizumab-in-early-triple-negative-breast-cancer-the-randomized-phase-3"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "Nature Medicine"
source_url: "https://www.nature.com/articles/s41591-026-04565-6"
published_at: "2026-09-01T12:00:00.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Atezolizumab plus neoadjuvant chemotherapy in early triple-negative breast cancer: NSABP B-59/Gepa
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/nature-3-atezolizumab-in-early-triple-negative-breast-cancer-the-randomized-phase-3
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** Nature Medicine
- **Source URL:** [Original Journal Publication](https://www.nature.com/articles/s41591-026-04565-6)
- **Published At:** 2026-09-01T12:00:00.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- The randomized, double-blind phase 3 NSABP B-59/GeparDouze trial tested the addition of **atezolizumab** to sequential taxane–carboplatin–anthracycline neoadjuvant chemotherapy in stage II–III **triple-negative breast cancer (TNBC)**. - 1,550 centrally confirmed TNBC patients were randomized: 773 to atezolizumab and 777 to placebo; treatment included paclitaxel, carboplatin, followed by anthracycline–cyclophosphamide, with adjuvant study drug to complete 1 year. - The primary endpoint, **event-free survival (EFS)** at 4 years, was not significantly improved by adding atezolizumab (HR 0.80, 95% CI 0.62–1.03; stratified log-rank P = 0.083); absolute 4-year EFS difference was 3.3%. - **Overall survival (OS)** hazard ratio was 0.86 (95% CI 0.62–1.19) with a 4-year absolute benefit of 0.7%. - Prespecified subgroup analyses suggested heterogeneity; a statistically significant interaction indicated benefit for patients with clinical lymph node involvement (P interaction = 0.039). - Pathologic complete response (pCR), distant disease-free survival (DDFS) and other secondary endpoints were analyzed but specific numeric outcomes beyond those reported in the abstract were not provided in the source text. - Safety: grade ≥3 treatment-emergent adverse events occurred in 75.3% (atezo) versus 73.4% (placebo); immune-related adverse events were 27.6% versus 11.4%. - Discontinuations in the neoadjuvant phase occurred in 25.5% of patients on atezolizumab and 18.8% on placebo. - An exploratory mRNA-based analysis suggested that patients with **basal-like immune-activated** TNBC and tumors with high **tumor-infiltrating lymphocytes (TILs)** may derive greater benefit from adding atezolizumab. - The authors propose TNBC molecular subtyping and quantification of TILs as potential strategies to identify patients more likely to benefit from adding immune checkpoint inhibitors to neoadjuvant chemotherapy. - ClinicalTrials.gov identifier for the trial is NCT03281954.
## Clinical Analysis & Structured Key Points
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[articles](https://www.nature.com/nm/articles?type=article) 4. article Atezolizumab in early triple-negative breast cancer: the randomized phase 3 NSABP B-59/GeparDouze trial [ Download PDF ](https://www.nature.com/articles/s41591-026-04565-6.pdf) [ Download PDF ](https://www.nature.com/articles/s41591-026-04565-6.pdf) * Article * [Open access](https://www.springernature.com/gp/open-science/about/the-fundamentals-of-open-access-and-open-research) * Published: 01 September 2026 # Atezolizumab in early triple-negative breast cancer: the randomized phase 3 NSABP B-59/GeparDouze trial * [Sibylle Loibl](https://www.nature.com/articles/s41591-026-04565-6#auth-Sibylle-Loibl-Aff1-Aff2-Aff3) [ORCID: orcid.org/0000-0001-6488-4958](https://orcid.org/0000-0001-6488-4958)[1](https://www.nature.com/articles/s41591-026-04565-6#Aff1),[2](https://www.nature.com/articles/s41591-026-04565-6#Aff2),[3](https://www.nature.com/articles/s41591-026-04565-6#Aff3), * [Gong Tang](https://www.nature.com/articles/s41591-026-04565-6#auth-Gong-Tang-Aff4)[4](https://www.nature.com/articles/s41591-026-04565-6#Aff4), * [Valentina Nekljudova](https://www.nature.com/articles/s41591-026-04565-6#auth-Valentina-Nekljudova-Aff1) [ORCID: orcid.org/0000-0002-2801-7387](https://orcid.org/0000-0002-2801-7387)[1](https://www.nature.com/articles/s41591-026-04565-6#Aff1), * [Priya Rastogi](https://www.nature.com/articles/s41591-026-04565-6#auth-Priya-Rastogi-Aff5-Aff6)[5](https://www.nature.com/articles/s41591-026-04565-6#Aff5),[6](https://www.nature.com/articles/s41591-026-04565-6#Aff6), * [Sivaramakrishna Rachakonda](https://www.nature.com/articles/s41591-026-04565-6#auth-Sivaramakrishna-Rachakonda-Aff1) [ORCID: orcid.org/0000-0002-2319-2821](https://orcid.org/0000-0002-2319-2821)[1](https://www.nature.com/articles/s41591-026-04565-6#Aff1), * [Mattea Reinisch](https://www.nature.com/articles/s41591-026-04565-6#auth-Mattea-Reinisch-Aff7-Aff8)[7](https://www.nature.com/articles/s41591-026-04565-6#Aff7),[8](https://www.nature.com/articles/s41591-026-04565-6#Aff8), * [Joshua Acosta](https://www.nature.com/articles/s41591-026-04565-6#auth-Joshua-Acosta-Aff5-Aff9)[5](https://www.nature.com/articles/s41591-026-04565-6#Aff5),[9](https://www.nature.com/articles/s41591-026-04565-6#Aff9), * [Andreas Schneeweiss](https://www.nature.com/articles/s41591-026-04565-6#auth-Andreas-Schneeweiss-Aff10)[10](https://www.nature.com/articles/s41591-026-04565-6#Aff10), * [Christie Hilton](https://www.nature.com/articles/s41591-026-04565-6#auth-Christie-Hilton-Aff5-Aff9)[5](https://www.nature.com/articles/s41591-026-04565-6#Aff5),[9](https://www.nature.com/articles/s41591-026-04565-6#Aff9), * [Sabine Seiler](https://www.nature.com/articles/s41591-026-04565-6#auth-Sabine-Seiler-Aff1-Aff11)[1](https://www.nature.com/articles/s41591-026-04565-6#Aff1),[11](https://www.nature.com/articles/s41591-026-04565-6#Aff11), * [Rohit Bhargava](https://www.nature.com/articles/s41591-026-04565-6#auth-Rohit-Bhargava-Aff12) [ORCID: orcid.org/0000-0002-1225-8418](https://orcid.org/0000-0002-1225-8418)[12](https://www.nature.com/articles/s41591-026-04565-6#Aff12), * [Thomas Karn](https://www.nature.com/articles/s41591-026-04565-6#auth-Thomas-Karn-Aff13) [ORCID: orcid.org/0000-0002-3264-6573](https://orcid.org/0000-0002-3264-6573)[13](https://www.nature.com/articles/s41591-026-04565-6#Aff13), * [Patricia Cortazar](https://www.nature.com/articles/s41591-026-04565-6#auth-Patricia-Cortazar-Aff14)[14](https://www.nature.com/articles/s41591-026-04565-6#Aff14), * [Fernando Moreno](https://www.nature.com/articles/s41591-026-04565-6#auth-Fernando-Moreno-Aff15-Aff16)[15](https://www.nature.com/articles/s41591-026-04565-6#Aff15),[16](https://www.nature.com/articles/s41591-026-04565-6#Aff16), * [Jay Andersen](https://www.nature.com/articles/s41591-026-04565-6#auth-Jay-Andersen-Aff17)[17](https://www.nature.com/articles/s41591-026-04565-6#Aff17), * [Stephani Christensen](https://www.nature.com/articles/s41591-026-04565-6#auth-Stephani-Christensen-Aff18)[18](https://www.nature.com/articles/s41591-026-04565-6#Aff18), * [Peter Klare](https://www.nature.com/articles/s41591-026-04565-6#auth-Peter-Klare-Aff19)[19](https://www.nature.com/articles/s41591-026-04565-6#Aff19), * [Sujatha Murali](https://www.nature.com/articles/s41591-026-04565-6#auth-Sujatha-Murali-Aff20)[20](https://www.nature.com/articles/s41591-026-04565-6#Aff20), * [Serafín Morales](https://www.nature.com/articles/s41591-026-04565-6#auth-Seraf_n-Morales-Aff21) [ORCID: orcid.org/0000-0001-7445-4193](https://orcid.org/0000-0001-7445-4193)[21](https://www.nature.com/articles/s41591-026-04565-6#Aff21), * [Jens Huober](https://www.nature.com/articles/s41591-026-04565-6#auth-Jens-Huober-Aff22-Aff23)[22](https://www.nature.com/articles/s41591-026-04565-6#Aff22),[23](https://www.nature.com/articles/s41591-026-04565-6#Aff23), * [Jean-François Boileau](https://www.nature.com/articles/s41591-026-04565-6#auth-Jean_Fran_ois-Boileau-Aff24)[24](https://www.nature.com/articles/s41591-026-04565-6#Aff24), * [Álvaro Rodríguez-Lescure](https://www.nature.com/articles/s41591-026-04565-6#auth-_lvaro-Rodr_guez_Lescure-Aff16-Aff25) [ORCID: orcid.org/0000-0002-6823-5290](https://orcid.org/0000-0002-6823-5290)[16](https://www.nature.com/articles/s41591-026-04565-6#Aff16),[25](https://www.nature.com/articles/s41591-026-04565-6#Aff25), * [Dominique Boudreau](https://www.nature.com/articles/s41591-026-04565-6#auth-Dominique-Boudreau-Aff26)[26](https://www.nature.com/articles/s41591-026-04565-6#Aff26), * [Peter J. Polewski](https://www.nature.com/articles/s41591-026-04565-6#auth-Peter_J_-Polewski-Aff27) [ORCID: orcid.org/0009-0006-1875-2632](https://orcid.org/0009-0006-1875-2632)[27](https://www.nature.com/articles/s41591-026-04565-6#Aff27), * [Julia Teply-Szymanski](https://www.nature.com/articles/s41591-026-04565-6#auth-Julia-Teply_Szymanski-Aff28) [ORCID: orcid.org/0000-0002-3880-1968](https://orcid.org/0000-0002-3880-1968)[28](https://www.nature.com/articles/s41591-026-04565-6#Aff28), * [João Mouta](https://www.nature.com/articles/s41591-026-04565-6#auth-Jo_o-Mouta-Aff29) [ORCID: orcid.org/0009-0002-2850-6866](https://orcid.org/0009-0002-2850-6866)[29](https://www.nature.com/articles/s41591-026-04565-6#Aff29), * [Eleftherios P. Mamounas](https://www.nature.com/articles/s41591-026-04565-6#auth-Eleftherios_P_-Mamounas-Aff30)[30](https://www.nature.com/articles/s41591-026-04565-6#Aff30), * [Carsten Denkert](https://www.nature.com/articles/s41591-026-04565-6#auth-Carsten-Denkert-Aff1-Aff3-Aff28) [ORCID: orcid.org/0000-0002-2249-0982](https://orcid.org/0000-0002-2249-0982)[1](https://www.nature.com/articles/s41591-026-04565-6#Aff1),[3](https://www.nature.com/articles/s41591-026-04565-6#Aff3),[28](https://www.nature.com/articles/s41591-026-04565-6#Aff28) [na1](https://www.nature.com/articles/s41591-026-04565-6#na1), * [Norman Wolmark](https://www.nature.com/articles/s41591-026-04565-6#auth-Norman-Wolmark-Aff5-Aff6) [ORCID: orcid.org/0000-0001-7156-1110](https://orcid.org/0000-0001-7156-1110)[5](https://www.nature.com/articles/s41591-026-04565-6#Aff5),[6](https://www.nature.com/articles/s41591-026-04565-6#Aff6) [na1](https://www.nature.com/articles/s41591-026-04565-6#na1) & * … * [Charles E. Geyer Jr.](https://www.nature.com/articles/s41591-026-04565-6#auth-Charles_E_-Geyer-Aff5-Aff6) [ORCID: orcid.org/0000-0002-2379-5702](https://orcid.org/0000-0002-2379-5702)[5](https://www.nature.com/articles/s41591-026-04565-6#Aff5),[6](https://www.nature.com/articles/s41591-026-04565-6#Aff6) [na1](https://www.nature.com/articles/s41591-026-04565-6#na1) Show authors [_Nature Medicine_](https://www.nature.com/nm) (2026) [Cite this article](https://www.nature.com/articles/s41591-026-04565-6#citeas) [ Save article ](https://www.nature.com/articles/s41591-026-04565-6/save-research?_csrf=-tzVTxEVsbkO38_9gt_RiMR1mK3sjflG) [ View saved research ](https://www.nature.com/saved-research) ## Abstract Triple-negative breast cancer (TNBC) is an aggressive subtype with an activated tumor immune microenvironment. The multicenter, multinational, double-blinded NSABP B-59/GeparDouze trial evaluated the addition of atezolizumab (atezo) (773 patients randomized) or placebo (777 patients) to sequential taxane–carboplatin–anthracycline-based neoadjuvant chemotherapy in stage II–III TNBC. The addition of atezo did not significantly improve the primary endpoint of event-free survival (EFS) (HR, 0.80 (95% CI, 0.062–1.03); stratified log-rank _P_ = 0.083, 4-year EFS rates difference 3.3%). The HR for overall survival was 0.86 (95% CI, 0.62–1.19), with a 4-year benefit of 0.7%. Prespecified subgroup analyses suggested heterogeneity in EFS, with benefit of atezo in patients presenting with clinical lymph node involvement (_P_ interaction = 0.039). Treatment-emergent adverse events with grades ≥3 were reported in 75.3% (atezo) versus 73.4% (placebo), and immune-related adverse events were reported in 27.6% (atezo) versus 11.4% (placebo). A total of 196 (25.5%) patients discontinued atezo and 143 (18.8%) patients discontinued placebo in the neoadjuvant phase. In an exploratory mRNA-based subset analysis, patients with basal-like immune-activated tumors may have benefited from atezo. TNBC subtyping to identify basal-like immune-activated tumors and quantification of tumor-infiltrating lymphocytes to identify tumors with high tumor-infiltrating lymphocyte counts could be a promising strategy to identify patients who benefit from the addition of immune checkpoint inhibitors to neoadjuvant chemotherapy. ClinicalTrials.gov registration: [NCT03281954](https://clinicaltrials.gov/study/NCT03281954). ### Explore related subjects Discover the latest articles and news in related subjects. * [Biomarkers](https://www.nature.com/subjects/biomarkers) * [Breast cancer](https://www.nature.com/subjects/breast-cancer) * [Cancer therapy](https://www.nature.com/subjects/cancer-therapy) ## Article PDF ## Main Triple-negative breast cancer (TNBC) is an aggressive and relatively immunogenic subtype with potential susceptibility to immune checkpoint inhibitors (ICIs)[1](https://www.nature.com/articles/s41591-026-04565-6#ref-CR1 "Ignatiadis, M. et al. Gene modules and response to neoadjuvant chemotherapy in breast cancer subtypes: a pooled analysis. J. Clin. Oncol. 30, 1996–2004 \(2012\)."),[2](https://www.nature.com/articles/s41591-026-04565-6#ref-CR2 "Berger, M. F. & Mardis, E. R. The emerging clinical relevance of genomics in cancer medicine. Nat. Rev. Clin. Oncol. 15, 353–365 \(2018\)."). Several neoadjuvant studies in early TNBC have shown a moderately increased pathological complete response (pCR) rate of neoadjuvant chemotherapy (NACT) with ICIs[3](https://www.nature.com/articles/s41591-026-04565-6#ref-CR3 "Loibl, S. et al. A randomised phase II study investigating durvalumab in addition to an anthracycline taxane-based neoadjuvant therapy in early triple-negative breast cancer: clinical results and biomarker analysis of GeparNuevo study. Ann. Oncol. 30, 1279–1288 \(2019\)."),[4](https://www.nature.com/articles/s41591-026-04565-6#ref-CR4 "Gianni, L. et al. Pathologic complete response \(pCR\) to neoadjuvant treatment with or without atezolizumab in triple-negative, early high-risk and locally advanced breast cancer: NeoTRIP Michelangelo randomized study. Ann. Oncol. 33, 534–543 \(2022\)."). In addition to pCR improvement, KEYNOTE-522 showed a statistically significant improvement in event-free survival (EFS) and overall survival (OS), irrespective of programmed death-ligand 1 (PD-L1) status, with the addition of anti-PD-1 antibody pembrolizumab to chemotherapy[5](https://www.nature.com/articles/s41591-026-04565-6#ref-CR5 "Schmid, P. et al. Overall survival with pembrolizumab in early-stage triple-negative breast cancer. N. Engl. J. Med. 391, 1981–1991 \(2024\)."),[6](https://www.nature.com/articles/s41591-026-04565-6#ref-CR6 "Schmid, P. et al. Event-free survival with pembrolizumab in early triple-negative breast cancer. N. Engl. J. Med. 386, 556–567 \(2022\)."). Atezolizumab, an anti-PD-L1 antibody, significantly improved progression-free survival when added to nab-paclitaxel for the first-line treatment of metastatic, PD-L1-positive TNBC[7](https://www.nature.com/articles/s41591-026-04565-6#ref-CR7 "Schmid, P. et al. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer \(IMpassion130\): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 21, 44–59 \(2020\)."). It also improved the pCR rate of early-stage TNBC with a trend for improved long-term outcomes when added to taxane–anthracycline-based NACT[8](https://www.nature.com/articles/s41591-026-04565-6#ref-CR8 "Mittendorf, E. A. et al. 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 396, 1090–1100 \(2020\)."). NSABP B-59/GeparDouze ([NCT03281954](https://clinicaltrials.gov/ct2/show/NCT03281954)) was an international, double-blind, placebo-controlled, academic phase 3 clinical trial which investigated whether the addition of atezolizumab to neoadjuvant taxane–carboplatin–anthracycline-based chemotherapy would improve outcomes for patients with stages II–III centrally confirmed TNBC. The study was developed as a contemporary to the global KEYNOTE-522 trial. The study design is shown in Extended Data Fig. [1](https://www.nature.com/articles/s41591-026-04565-6#Fig5). In this Article, we present the primary analysis (4-year EFS results) and secondary analyses (pCR, distant disease-free survival (DDFS), OS, safety) of the NSABP B-59/GeparDouze trial along with exploratory translational investigations focusing on the prognostic and predictive potential of tumor-infiltrating lymphocytes (TILs). In a prospectively planned sub-study, mRNA analysis and TNBC molecular subtyping of primary tumors were integrated. An exploratory analysis of the outcomes by mRNA-based TNBC subtypes was implemented and compared with the TIL results. ## Results ### Patients and therapy Between 29 December 2017 and 28 May 2021, 2,188 patients were screened and 1,550 patients with centrally confirmed TNBC were enrolled across 353 sites in 4 countries (USA, Germany, Canada and Spain), with 773 patients randomly assigned to receive neoadjuvant atezolizumab 1,200 mg IV and 777 patients to receive placebo IV every 3 weeks concurrently with NACT. Chemotherapy was composed of paclitaxel 80 mg m−2 IV weekly × 12 doses with carboplatin area under the concentration-time curve (AUC) of 5 IV on day 1 and every 3 weeks for 4 cycles, followed by doxorubicin (anthracyclin, A) 60 mg m−2 IV or epirubicin (E) 90 mg m−2 IV with cyclophosphamide (C) 600 mg m−2 IV on day 1 and every 2 weeks or 3 weeks per investigator discretion for 4 cycles (AC and EC, respectively). Adjuvant atezolizumab or placebo was administered to complete 1 year of study therapy. The treatment assignment and analysis
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