Evidence map›Paper›PMID 41564397›Full record

Trial reportThe New England journal of medicine2026

Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer.

Sara M Tolaney, Evandro de Azambuja, Kevin Kalinsky, Sherene Loi, Sung-Bae Kim, Clinton Yam, Bernardo Rapoport, Seock-Ah Im, Barbara Pistilli, Wassim Mchayleh and 11 more

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

Trial report in The New England journal of medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05382286 (A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1), which is not on this map. Cited by 41 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 3 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.

NCT05382286 phase3active not recruitingnot on this map

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

TypeinterventionalSponsorGilead SciencesRan2022 to 2027Enrolled443ConditionsTriple Negative Breast Cancer, PD-L1 PositiveArmsSacituzumab Govitecan-hziy, Pembrolizumab, Paclitaxel, nab-Paclitaxel, Gemcitabine
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  10. Primary G-CSF prophylaxis in sacituzumab govitecan-treated mTNBC: real-world evidence from a multinational CEBCC-102 cohort.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Sara M TolaneyDana-Farber Cancer Institute, Harvard Medical School, Boston.
Evandro de AzambujaInstitut Jules Bordet, Hôpital Universitaire de Bruxelles and Université Libre de Bruxelles, Brussels.ORCID 0000-0001-9501-4509
Kevin KalinskyWinship Cancer Institute, Emory University, Atlanta.
Sherene LoiPeter MacCallum Cancer Centre and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.
Sung-Bae KimAsan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Clinton YamUniversity of Texas M.D. Anderson Cancer Center, Houston.ORCID 0000-0002-0809-0851
Bernardo RapoportMedical Oncology Centre of Rosebank, Clinical and Translational Research Unit, Saxonwold, South Africa.
Seock-Ah ImSeoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, Seoul, South Korea.
Barbara PistilliDepartment of Cancer Medicine, Gustave Roussy, Villejuif, France.ORCID 0000-0002-9184-7199
Wassim MchaylehAdventHealth Cancer Institute, Orlando, FL.
David W CesconPrincess Margaret Cancer Centre, University Health Network, Toronto.
Junichiro WatanabeJuntendo University Graduate School of Medicine, Tokyo.
Manuel Alejandro Lara BañuelasSCIENTIA Investigación Clínica, Chihuahua, Mexico.
Ruffo Freitas-JuniorAraujo Jorge Cancer Hospital, Goias Anticancer Association, Goiânia, Brazil.
Javier Salvador BofillMedical Oncology Department, Hospital Universitario Virgen del Rocio, Seville, Spain.
Maryam AfshariGilead Sciences, Foster City, CA.
Dianna GaryGilead Sciences, Foster City, CA.
Lu WangGilead Sciences, Foster City, CA.
Catherine LaiGilead Sciences, Foster City, CA.
Peter SchmidCentre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London.
ASCENT-04/KEYNOTE-D19 Clinical Trial Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTriple-negative breast cancer is an aggressive breast cancer subtype, and there remains an unmet need to improve outcomes in patients with previously untreated, programmed death ligand 1 (PD-L1)-positive, locally advanced unresectable or metastatic triple-negative breast cancer.

methodsIn this phase 3, open-label, international trial, we randomly assigned patients in a 1:1 ratio to receive sacituzumab govitecan plus pembrolizumab or chemotherapy plus pembrolizumab. The primary end point was progression-free survival as assessed by blinded independent central review. Secondary end points included overall survival, objective response (complete or partial response) and duration of response as assessed by blinded independent central review, and safety.

resultsA total of 443 patients were randomly assigned to receive sacituzumab govitecan plus pembrolizumab (221 patients) or chemotherapy plus pembrolizumab (222 patients). The median progression-free survival was 11.2 months (95% confidence interval [CI], 9.3 to 16.7) with sacituzumab govitecan plus pembrolizumab and 7.8 months (95% CI, 7.3 to 9.3) with chemotherapy plus pembrolizumab (hazard ratio for disease progression or death, 0.65; 95% CI, 0.51 to 0.84; two-sided P<0.001). Data for overall survival were immature. The percentage of patients with an objective response was 60% (95% CI, 53 to 66) with sacituzumab govitecan plus pembrolizumab and 53% (95% CI, 46 to 60) with chemotherapy plus pembrolizumab; among patients with a response, the median duration of response was 16.5 months (95% CI, 12.7 to 19.5) and 9.2 months (95% CI, 7.6 to 11.3), respectively. Adverse events of grade 3 or higher occurred in 71% of the patients receiving sacituzumab govitecan plus pembrolizumab and in 70% of those receiving chemotherapy plus pembrolizumab; the incidence of treatment discontinuation due to adverse events was 12% and 31%, respectively. Adverse events leading to death occurred in 3% of the patients in each group.

conclusionsSacituzumab govitecan plus pembrolizumab led to significantly longer progression-free survival than chemotherapy plus pembrolizumab among patients with previously untreated, PD-L1-positive, advanced triple-negative breast cancer. (Funded by Gilead Sciences; ASCENT-04/KEYNOTE-D19 ClinicalTrials.gov number, NCT05382286.).

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsImmunoconjugatesTriple Negative Breast NeoplasmsAdultAgedAged, 80 and overCamptothecinFemaleHumansImmune Checkpoint InhibitorsMiddle AgedProgrammed Cell Death 1 ReceptorProgression-Free SurvivalYoung AdultAntibodies, Monoclonal, HumanizedCamptothecinImmune Checkpoint InhibitorsImmunoconjugatespembrolizumabProgrammed Cell Death 1 Receptorsacituzumab govitecan

Identifiers

PMID41564397

What OpenQuestion holds

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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.