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

Rugo HS, Schmid P, Cortes J, Takano T, Fasching P, Park YH, Bianchini G, Franco SX, Villarreal-Garza C, Tredan O, Yin Y, Barroso-Sousa R, Peng X, Malhotra U, Smith KL, Bardia A (2026)

Publication Type: Journal article

Publication year: 2026

Journal

Future Oncology Future Medicine Ltd

Book Volume: 22

Pages Range: 2121-2129

Journal Issue: 18

DOI: 10.1080/14796694.2026.2701483

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. Clinical trial registration:www.clinicaltrials.gov identifier is NCT06841354.

Authors with CRIS profile

Peter Fasching Professur für Translationale Frauenheilkunde und Geburtshilfe

Involved external institutions

City of Hope Medical Center US United States (USA) (US) Queen Mary University of London GB United Kingdom (GB) PANGAEA Oncology S.A. ES Spain (ES) The Cancer Institute Hospital / がん研有明病院 JP Japan (JP) Sungkyunkwan University (SKKU) KR Korea, Republic of (KR) Ospedale San Raffaele (früher: Centro San Raffaele del Monte Tabor Foundation) IT Italy (IT) Luis Carlos Sarmiento Angulo Cancer Treatment and Research Center (CTIC) / Centro de Tratamiento e investigación sobre cáncer Luis Carlos Sarmiento Angulo (CTIC) CO Colombia (CO) Hospital Zambrano Hellion MX Mexico (MX) Centre de recherche en cancérologie FR France (FR) Jiangsu Province Hospital / First Affiliated Hospital of Nanjing Medical University / 江苏省人民医院 CN China (CN) Hospital Brasília BR Brazil (BR) Merck & Co., Inc. / Merck Sharp & Dohme Corp (MSD) US United States (USA) (US) University of California Los Angeles (UCLA) US United States (USA) (US)

How to cite

APA:

Rugo, H.S., Schmid, P., Cortes, J., Takano, T., Fasching, P., Park, Y.H.,... Bardia, A. (2026). TroFuse-011 study design: sacituzumab tirumotecan with or without pembrolizumab for advanced triple-negative breast cancer with PD-L1 CPS <10. Future Oncology, 22(18), 2121-2129. https://doi.org/10.1080/14796694.2026.2701483

MLA:

Rugo, Hope S., et al. "TroFuse-011 study design: sacituzumab tirumotecan with or without pembrolizumab for advanced triple-negative breast cancer with PD-L1 CPS <10." Future Oncology 22.18 (2026): 2121-2129.

BibTeX: Download