Evidence map›Paper›PMID 42535874›Full record

ArticleFuture oncology (London, England)2026

TroFuse-011 study design: sacituzumab tirumotecan with or without pembrolizumab for advanced triple-negative breast cancer with PD-L1 CPS <10.

Hope S Rugo, Peter Schmid, Javier Cortes, Toshimi Takano, Peter A Fasching, Yeon Hee Park, Giampaolo Bianchini, Sandra Ximena Franco, Cynthia Villarreal-Garza, Olivier Tredan and 6 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Future oncology (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

16 authors.

Hope S RugoDepartment of Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Peter SchmidBarts Breast Cancer Centre, Barts Cancer Institute, Queen Mary University of London, London, UK.
Javier CortesInternational Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Barcelona, Spain.ORCID 0000-0001-7623-1583
Toshimi TakanoBreast Medical Oncology Department, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Peter A FaschingComprehensive Cancer Center Erlangen-Nuremberg, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.
Yeon Hee ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Giampaolo BianchiniDepartment of Medical Oncology, IRCCS Ospedale, San Raffaele, Milan, Italy.ORCID 0000-0002-6790-6267
Sandra Ximena FrancoCentro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo, Bogota, Colombia.
Cynthia Villarreal-GarzaTecnologico de Monterrey, Breast Cancer Center Hospital Zambrano Hellion TecSalud, San Pedro Garza García, Mexico.
Olivier TredanCentre Léon Bérard and Cancer Research Center of Lyon, Lyon, France.
Yongmei YinDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Romualdo Barroso-SousaOncology Unit, Rede Americas, Brasilia Hospital, Brasília, Brazil.
Xuan PengMerck & Co., Inc., Rahway, NJ, USA.
Usha MalhotraMerck & Co., Inc., Rahway, NJ, USA.
Karen Lisa SmithMerck & Co., Inc., Rahway, NJ, USA.
Aditya BardiaDivision of Hematology-Oncology, University of California Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients with advanced TNBC with PD-L1 CPS < 10 are typically treated with chemotherapy and experience poor outcomes. Sacituzumab tirumotecan (sac-TMT; MK-2870/SKB264) is a trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate with a unique, bifunctional linker that maximizes payload delivery to tumor cells. Combining sac-TMT with immunotherapy may improve outcomes given their complementary respective direct cytotoxic and immune-mediated antitumor effects regardless of tumor PD-L1 expression. The TroFuse-011 study evaluates sac-TMT with/without pembrolizumab versus treatment of physician's choice (TPC; paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) in previously untreated, centrally confirmed, locally recurrent unresectable or metastatic TNBC with PD-L1 CPS <10. Eligible adults with measurable disease per RECIST version 1.1, ECOG PS 0/1, and tumor tissue sample for central PD-L1 and TROP2 testing will be randomized to receive sac-TMT (arm A), sac-TMT plus pembrolizumab (arm B), or TPC (arm C). Primary endpoints include progression-free survival (PFS; arm A vs C and arm B vs C) and overall survival (OS; arm A vs C). Secondary endpoints include PFS (arm B vs A), OS (arm B vs C and arm B vs A), objective response rate (arm A vs C and arm B vs C), duration of response, patient-reported outcomes, and safety. Enrollment is ongoing.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenImmunoconjugatesTriple Negative Breast NeoplasmsCamptothecinFemaleHumansAntibodies, Monoclonal, HumanizedB7-H1 AntigenCamptothecinCD274 protein, humanImmunoconjugatespembrolizumabsacituzumab govitecanantibody-drug conjugateclinical trial protocolPD-L1 CPS <10pembrolizumabphase IIIsacituzumab tirumotecantargeted therapyTriple-negative breast cancer

Identifiers

PMID42535874
PMCPMC13432852

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Registered trials

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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.