TROPiCS-02: A Phase III Study Investigating Sacituzumab Govitecan in the Treatment of HR+/HER2- Metastatic Breast Cancer
Copyright policy )TROPiCS-02: A Phase III Study Investigating Sacituzumab Govitecan in the Treatment of HR+/HER2- Metastatic Breast Cancer
Patients with HR+/HER2- metastatic breast cancer (MBC) whose cancers have progressed despite conventional therapies represent an unmet clinical need. Trop-2, a transmembrane calcium signal transducer, is highly expressed in MBC and plays a role in tumor growth and progression. Sacituzumab govitecan (SG) is a novel antibody-drug conjugate comprising an Trop-2 antibody coupled to SN-38, the active metabolite of irinotecan, via a unique hydrolyzable linker. SG has demonstrated promising activity in a Phase I/II IMMU-132-01 basket study in heavily pretreated solid tumors, including HR+/HER2- MBC. We describe the registrational Phase III TROPiCS-02 study (NCT03901339), evaluating SG versus treatment of physician's choice in HR+/HER2- MBC. Trial registration number: NCT03901339.
- Harvard University United States
- Queen Mary University of London United Kingdom
- Vall d'Hebron Institute of Oncology (VHIO) Spain
- Institut Gustave Roussy France
- The University of Texas Southwestern Medical Center United States
Immunoconjugates, Cell Adhesion Molecules / antagonists & inhibitors, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, Receptor, ErbB-2, Camptothecin / therapeutic use, Drug Resistance, Mama - Càncer - Quimioteràpia, Breast Neoplasms / metabolism, sacituzumab govitecan, Antineoplastic Agents, Immunological, Humanized / administration & dosage, Monoclonal, Immunological / administration & dosage, Molecular Targeted Therapy, HR-positive, Neoplasm Metastasis, ENFERMEDADES::neoplasias::procesos neoplásicos::metástasis neoplásica, Tumor, Other subheadings::Other subheadings::Other subheadings::/drug therapy, Immunological / adverse effects, Breast Neoplasms / etiology, Treatment Outcome, Camptothecin / adverse effects, Retreatment, Female, metastatic breast cancer, ErbB-2 / antagonists & inhibitors, Receptor, Breast Neoplasms / drug therapy*, MBC, Camptothecin / analogs & derivatives*, Humanized / adverse effects, Trop-2, Immunoconjugates / administration & dosage, 610, Antineoplastic Agents, Breast Neoplasms, Antibodies, Monoclonal, Humanized, SN-38, Antibodies, Metàstasi, Antigens, Neoplasm, Biomarkers, Tumor, Humans, Immunological / therapeutic use*, Antigens, Humanized / therapeutic use*, Neoplasm Staging, antibody–drug conjugate, Breast Neoplasms / pathology*, Immunoconjugates / adverse effects, Immunoconjugates / therapeutic use*, DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Metastasis, Drug Resistance, Neoplasm, Neoplasm, Camptothecin, Camptothecin / administration & dosage, HER2-negative, ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama, Cell Adhesion Molecules, Biomarkers, DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
Immunoconjugates, Cell Adhesion Molecules / antagonists & inhibitors, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, Receptor, ErbB-2, Camptothecin / therapeutic use, Drug Resistance, Mama - Càncer - Quimioteràpia, Breast Neoplasms / metabolism, sacituzumab govitecan, Antineoplastic Agents, Immunological, Humanized / administration & dosage, Monoclonal, Immunological / administration & dosage, Molecular Targeted Therapy, HR-positive, Neoplasm Metastasis, ENFERMEDADES::neoplasias::procesos neoplásicos::metástasis neoplásica, Tumor, Other subheadings::Other subheadings::Other subheadings::/drug therapy, Immunological / adverse effects, Breast Neoplasms / etiology, Treatment Outcome, Camptothecin / adverse effects, Retreatment, Female, metastatic breast cancer, ErbB-2 / antagonists & inhibitors, Receptor, Breast Neoplasms / drug therapy*, MBC, Camptothecin / analogs & derivatives*, Humanized / adverse effects, Trop-2, Immunoconjugates / administration & dosage, 610, Antineoplastic Agents, Breast Neoplasms, Antibodies, Monoclonal, Humanized, SN-38, Antibodies, Metàstasi, Antigens, Neoplasm, Biomarkers, Tumor, Humans, Immunological / therapeutic use*, Antigens, Humanized / therapeutic use*, Neoplasm Staging, antibody–drug conjugate, Breast Neoplasms / pathology*, Immunoconjugates / adverse effects, Immunoconjugates / therapeutic use*, DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Metastasis, Drug Resistance, Neoplasm, Neoplasm, Camptothecin, Camptothecin / administration & dosage, HER2-negative, ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama, Cell Adhesion Molecules, Biomarkers, DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
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