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Peer-reviewedCC BY-NC-ND 4.0Future Oncology

TroFuse-032 study design: pembrolizumab plus sacituzumab tirumotecan or chemotherapy followed by pembrolizumab plus chemotherapy as neoadjuvant therapy for early-stage, triple-negative breast cancer or HR-low+/HER2− breast cancer

  • Peter Schmid1
  • Javier Cortes2,3
  • Rina Hui4,5
  • Norikazu Masuda6
  • Ana C. Garrido-Castro7,8
  • Delphine Loirat9
  • Zhi-Ming Shao10,11
  • Yeon Hee Park12
  • Jing Wei13
  • Francisco Beca13
  • Usha Malhotra13
  • Nadia Harbeck14
14 affiliations
  1. 1Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London, UK
  2. 2Department of Oncology, International Oncology Bureau (IOB) Madrid, Institute of Oncology, Hospital Beata María Ana, Madrid, Spain
  3. 3International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Barcelona, Spain
  4. 4Centre of Cancer Medicine, LKS Faculty of Medicine, University of Hong Kong, Pokfulam, Hong Kong
  5. 5Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia
  6. 6Department of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan
  7. 7Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA
  8. 8Department of Medicine, Harvard Medical School, Boston, MA, USA
  9. 9Medical Oncology Department, Institut Curie, Institute of Women’s Cancer, Paris, France
  10. 10Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China
  11. 11Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
  12. 12Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
  13. 13Merck & Co., Inc ., Rahway, NJ, USA
  14. 14Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center (CCC Munich LMU), LMU University Hospital, LMU Medizin, Ludwig-Maximilians-Universität München, Munich, Germany
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Abstract

For most patients with high-risk, early-stage, triple-negative breast cancer (TNBC), neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab after surgery is considered the standard regimen, with the same approach increasingly being used for hormone receptor-low‒positive/human epidermal growth factor receptor 2–negative breast cancer (HR-low+/HER2− BC). However, lack of pathologic complete response (pCR) after neoadjuvant therapy is associated with higher risks of recurrence/mortality, representing an area of unmet need. 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. TroFuse-032 (NCT06966700) is a phase III study evaluating neoadjuvant pembrolizumab plus sac-TMT followed by pembrolizumab plus chemotherapy versus neoadjuvant pembrolizumab plus chemotherapy for high-risk, early-stage, resectable TNBC or HR-low+/HER2− BC. Eligible participants will be randomized 1:1 to receive neoadjuvant pembrolizumab plus sac-TMT followed by pembrolizumab plus paclitaxel/carboplatin (arm 1) or neoadjuvant pembrolizumab plus paclitaxel/carboplatin followed by pembrolizumab plus doxorubicin or epirubicin plus cyclophosphamide (arm 2). After surgery, participants will receive adjuvant pembrolizumab (if pCR) or pembrolizumab-based treatment (if residual disease; Graphical Abstract). Primary endpoints are pCR (ypT0/Tis ypN0) and event-free survival. Secondary endpoints include overall survival, pCR (ypT0 ypN0), patient-reported outcomes, and safety. Enrollment is ongoing.

Clinical trial registration: NCT06966700 (ClinicalTrials.gov); EU CT 2024-520190-12 (EudraCT)

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Cite

BibTeXRIS
BibTeX
@article{schmid2026trofuse032,
  title = {{TroFuse-032 study design: pembrolizumab plus sacituzumab tirumotecan or chemotherapy followed by pembrolizumab plus chemotherapy as neoadjuvant therapy for early-stage, triple-negative breast cancer or HR-low+/HER2− breast cancer}},
  author = {Peter Schmid and Javier Cortes and Rina Hui and Norikazu Masuda and Ana C. Garrido-Castro and Delphine Loirat and Zhi-Ming Shao and Yeon Hee Park and Jing Wei and Francisco Beca and Usha Malhotra and Nadia Harbeck},
  journal = {Future Oncology},
  year = {2026},
  month = oct,
  doi = {10.1080/14796694.2026.2732590},
  url = {https://doi.org/10.1080/14796694.2026.2732590},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - TroFuse-032 study design: pembrolizumab plus sacituzumab tirumotecan or chemotherapy followed by pembrolizumab plus chemotherapy as neoadjuvant therapy for early-stage, triple-negative breast cancer or HR-low+/HER2− breast cancer
AU  - Peter Schmid
AU  - Javier Cortes
AU  - Rina Hui
AU  - Norikazu Masuda
AU  - Ana C. Garrido-Castro
AU  - Delphine Loirat
AU  - Zhi-Ming Shao
AU  - Yeon Hee Park
AU  - Jing Wei
AU  - Francisco Beca
AU  - Usha Malhotra
AU  - Nadia Harbeck
PY  - 2026
DA  - 2026/10/14
JO  - Future Oncology
DO  - 10.1080/14796694.2026.2732590
UR  - https://doi.org/10.1080/14796694.2026.2732590
AB  - For most patients with high-risk, early-stage, triple-negative breast cancer (TNBC), neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab after surgery is considered the standard regimen, with the same approach increasingly being used for hormone receptor-low‒positive/human epidermal growth factor receptor 2–negative breast cancer (HR-low+/HER2− BC). However, lack of pathologic complete response (pCR) after neoadjuvant therapy is associated with higher risks of recurrence/mortality, representing an area of unmet need. 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. TroFuse-032 (NCT06966700) is a phase III study evaluating neoadjuvant pembrolizumab plus sac-TMT followed by pembrolizumab plus chemotherapy versus neoadjuvant pembrolizumab plus chemotherapy for high-risk, early-stage, resectable TNBC or HR-low+/HER2− BC. Eligible participants will be randomized 1:1 to receive neoadjuvant pembrolizumab plus sac-TMT followed by pembrolizumab plus paclitaxel/carboplatin (arm 1) or neoadjuvant pembrolizumab plus paclitaxel/carboplatin followed by pembrolizumab plus doxorubicin or epirubicin plus cyclophosphamide (arm 2). After surgery, participants will receive adjuvant pembrolizumab (if pCR) or pembrolizumab-based treatment (if residual disease; Graphical Abstract). Primary endpoints are pCR (ypT0/Tis ypN0) and event-free survival. Secondary endpoints include overall survival, pCR (ypT0 ypN0), patient-reported outcomes, and safety. Enrollment is ongoing.  Clinical trial registration: NCT06966700 (ClinicalTrials.gov); EU CT 2024-520190-12 (EudraCT)
SN  - 1479-6694
SN  - 1744-8301
ER  -