{
  "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.\n\nClinical trial registration: NCT06966700 (ClinicalTrials.gov); EU CT 2024-520190-12 (EudraCT)",
  "abstract_shown": true,
  "affiliations": [
    "Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London, UK",
    "Department of Oncology, International Oncology Bureau (IOB) Madrid, Institute of Oncology, Hospital Beata María Ana, Madrid, Spain",
    "International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Barcelona, Spain",
    "Centre of Cancer Medicine, LKS Faculty of Medicine, University of Hong Kong, Pokfulam, Hong Kong",
    "Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia",
    "Department of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan",
    "Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA",
    "Department of Medicine, Harvard Medical School, Boston, MA, USA",
    "Medical Oncology Department, Institut Curie, Institute of Women’s Cancer, Paris, France",
    "Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China",
    "Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China",
    "Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea",
    "Merck & Co., Inc ., Rahway, NJ, USA",
    "Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center (CCC Munich LMU), LMU University Hospital, LMU Medizin, Ludwig-Maximilians-Universität München, Munich, Germany"
  ],
  "article_type": "methods article",
  "arxiv": null,
  "author_total": 12,
  "authors": [
    {
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        0
      ],
      "name": "Peter Schmid"
    },
    {
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        1,
        2
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      "name": "Javier Cortes"
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    {
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        3,
        4
      ],
      "name": "Rina Hui"
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    {
      "affs": [
        5
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      "name": "Norikazu Masuda"
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    {
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        6,
        7
      ],
      "name": "Ana C. Garrido-Castro"
    },
    {
      "affs": [
        8
      ],
      "name": "Delphine Loirat"
    },
    {
      "affs": [
        9,
        10
      ],
      "name": "Zhi-Ming Shao"
    },
    {
      "affs": [
        11
      ],
      "name": "Yeon Hee Park"
    },
    {
      "affs": [
        12
      ],
      "name": "Jing Wei"
    },
    {
      "affs": [
        12
      ],
      "name": "Francisco Beca"
    },
    {
      "affs": [
        12
      ],
      "name": "Usha Malhotra"
    },
    {
      "affs": [
        13
      ],
      "name": "Nadia Harbeck"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/4shycqzfsyb4f.bib",
  "cited_by": 0,
  "doi": "10.1080/14796694.2026.2732590",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13733134/",
  "id": "4shycqzfsyb4f",
  "issns": [
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    "1744-8301"
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  "landing_url": "https://doi.org/10.1080/14796694.2026.2732590",
  "language": "en",
  "licence": "CC-BY-NC-ND-4.0",
  "licence_label": "CC BY-NC-ND 4.0",
  "licence_source": "article",
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  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Clinical Trial Protocol"
    ],
    [
      "heading",
      "Method"
    ],
    [
      "openalex",
      "1306|Breast Cancer Treatment Studies"
    ]
  ],
  "openalex": "W7221794384",
  "pdf_url": "https://www.tandfonline.com/doi/pdf/10.1080/14796694.2026.2732590?needAccess=true",
  "pmcid": "PMC13733134",
  "pmid": "42872715",
  "published": "2026-10-14",
  "publisher": "Taylor & Francis",
  "ris": "https://research.draconitic.com/paper/4shycqzfsyb4f.ris",
  "sources": [
    {
      "first_seen": "2026-11-08T12:22:59Z",
      "native_id": "PMC13733134",
      "source": "pmc",
      "url": "https://doi.org/10.1080/14796694.2026.2732590"
    }
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  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:1306|Breast Cancer Treatment Studies",
      "subfield": "oncology"
    }
  ],
  "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",
  "title_text": "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",
  "type": "peer-reviewed",
  "updated_at": "2026-11-08T12:22:59Z",
  "url": "https://research.draconitic.com/paper/4shycqzfsyb4f",
  "venue": "Future Oncology",
  "versions": []
}