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SACI-IO HR+: a randomized phase II trial of sacituzumab govitecan with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer.

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Title: SACI-IO HR+: a randomized phase II trial of sacituzumab govitecan with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer.
Authors: Garrido-Castro AC; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA., Kim SE; Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston, USA., Li T; Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston, USA., Desrosiers J; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA., Nanda R; Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, USA., Abdou Y; Lineberger Comprehensive Cancer Center, Division of Hematology-Oncology, University of North Carolina, Chapel Hill, USA., Clark AS; Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, USA., Sacks RL; Department of Hematology and Medical Oncology, Winship Cancer Institute at Emory University, Atlanta, USA., O'Connor T; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA., Sinclair N; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA., Lo S; Medical Oncology and Hematology, Stamford Hospital, Stamford, USA., Augdahl G; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA., Wrabel E; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA., DiLullo M; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA., Rahman T; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA., Patel A; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA., Hughes ME; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA., Baginska J; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA., Lange PB; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA., O'Meara T; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA., Keenan TE; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA., Gorthi A; Precede Biosciences, Boston, USA., D'Ippolito A; Precede Biosciences, Boston, USA., Painter CA; Precede Biosciences, Boston, USA., Eaton M; Precede Biosciences, Boston, USA., Barrett JC; Precede Biosciences, Boston, USA., Koca B; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA., Kurnia PT; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA., Perry AN; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA., Gomez Tejeda Zanudo J; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA., He M; Department of Pathology, Yale University School of Medicine, New Haven, USA., Dillon DA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA; Department of Pathology, Brigham and Women's Hospital, Boston, USA., Lin NU; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA., Burstein HJ; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA., Mittendorf EA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA; Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, USA., Jeselsohn R; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA., Rimm DL; Department of Pathology, Yale University School of Medicine, New Haven, USA., Tayob N; Harvard Medical School, Boston, USA; Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston, USA., Tolaney SM; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA. Electronic address: sara_tolaney@dfci.harvard.edu.
Source: Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2026 Jun 20. Date of Electronic Publication: 2026 Jun 20.
Publication Type: Journal Article
Journal Info: Publisher: Elsevier Country of Publication: England NLM ID: 9007735 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1569-8041 (Electronic) Linking ISSN: 09237534 NLM ISO Abbreviation: Ann Oncol Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: SACI-IO HR+: a randomized phase II trial of sacituzumab govitecan with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer.
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  Data: <searchLink fieldCode="AU" term="%22Garrido-Castro+AC%22">Garrido-Castro AC</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Kim+SE%22">Kim SE</searchLink>; Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Li+T%22">Li T</searchLink>; Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Desrosiers+J%22">Desrosiers J</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Nanda+R%22">Nanda R</searchLink>; Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, USA.<br /><searchLink fieldCode="AU" term="%22Abdou+Y%22">Abdou Y</searchLink>; Lineberger Comprehensive Cancer Center, Division of Hematology-Oncology, University of North Carolina, Chapel Hill, USA.<br /><searchLink fieldCode="AU" term="%22Clark+AS%22">Clark AS</searchLink>; Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, USA.<br /><searchLink fieldCode="AU" term="%22Sacks+RL%22">Sacks RL</searchLink>; Department of Hematology and Medical Oncology, Winship Cancer Institute at Emory University, Atlanta, USA.<br /><searchLink fieldCode="AU" term="%22O'Connor+T%22">O'Connor T</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Sinclair+N%22">Sinclair N</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Lo+S%22">Lo S</searchLink>; 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Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Hughes+ME%22">Hughes ME</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Baginska+J%22">Baginska J</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Lange+PB%22">Lange PB</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA.<br /><searchLink fieldCode="AU" term="%22O'Meara+T%22">O'Meara T</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Keenan+TE%22">Keenan TE</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Gorthi+A%22">Gorthi A</searchLink>; Precede Biosciences, Boston, USA.<br /><searchLink fieldCode="AU" term="%22D'Ippolito+A%22">D'Ippolito A</searchLink>; Precede Biosciences, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Painter+CA%22">Painter CA</searchLink>; Precede Biosciences, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Eaton+M%22">Eaton M</searchLink>; Precede Biosciences, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Barrett+JC%22">Barrett JC</searchLink>; Precede Biosciences, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Koca+B%22">Koca B</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Kurnia+PT%22">Kurnia PT</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Perry+AN%22">Perry AN</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Gomez+Tejeda+Zanudo+J%22">Gomez Tejeda Zanudo J</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA.<br /><searchLink fieldCode="AU" term="%22He+M%22">He M</searchLink>; Department of Pathology, Yale University School of Medicine, New Haven, USA.<br /><searchLink fieldCode="AU" term="%22Dillon+DA%22">Dillon DA</searchLink>; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA; Department of Pathology, Brigham and Women's Hospital, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Lin+NU%22">Lin NU</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Burstein+HJ%22">Burstein HJ</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Mittendorf+EA%22">Mittendorf EA</searchLink>; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA; Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Jeselsohn+R%22">Jeselsohn R</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Rimm+DL%22">Rimm DL</searchLink>; Department of Pathology, Yale University School of Medicine, New Haven, USA.<br /><searchLink fieldCode="AU" term="%22Tayob+N%22">Tayob N</searchLink>; Harvard Medical School, Boston, USA; Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston, USA.<br /><searchLink fieldCode="AU" term="%22Tolaney+SM%22">Tolaney SM</searchLink>; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA. Electronic address: sara_tolaney@dfci.harvard.edu.
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