TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2- metastatic breast cancer

Hope S Rugo; Aditya Bardia; Sara M Tolaney; Carlos Arteaga; Javier Cortes; Joohyuk Sohn; Frederik Marmé; Quan Hong; Rosemary J Delaney; Amir Hafeez; Fabrice André; Peter Schmid

doi:10.2217/fon-2020-0163

TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2- metastatic breast cancer

Future Oncol. 2020 Apr;16(12):705-715. doi: 10.2217/fon-2020-0163. Epub 2020 Mar 30.

Authors

Hope S Rugo¹, Aditya Bardia², Sara M Tolaney³, Carlos Arteaga⁴, Javier Cortes⁵, Joohyuk Sohn⁶, Frederik Marmé⁷, Quan Hong⁸, Rosemary J Delaney⁸, Amir Hafeez⁸, Fabrice André⁹, Peter Schmid¹⁰

Affiliations

¹ Department of Medicine (Hematology/Oncology), University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA 94115, USA.
² Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
³ Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02215, USA.
⁴ Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.
⁵ Medical Oncology Department, IOB Institute of Oncology, Quirosalud Group, Madrid & Barcelona, Spain and Senior clinical Researcher, Vall d´Hebron Institute of Oncology (VHIO), Barcelona, Spain.
⁶ Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
⁷ Medical Faculty Mannheim, Heidelberg University, University Hospital Mannheim, Germany.
⁸ Immunomedics, Morris Plains, NJ 07950, USA.
⁹ Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France.
¹⁰ Barts Cancer Institute, Queen Mary University of London, London, UK.

PMID: 32223649
DOI: 10.2217/fon-2020-0163

Abstract

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.

Keywords: HER2-negative; HR-positive; MBC; SN-38; Trop-2; antibody–drug conjugate; metastatic breast cancer; sacituzumab govitecan.

Publication types

Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial

MeSH terms

Antibodies, Monoclonal, Humanized / administration & dosage
Antibodies, Monoclonal, Humanized / adverse effects
Antibodies, Monoclonal, Humanized / therapeutic use*
Antigens, Neoplasm
Antineoplastic Agents, Immunological / administration & dosage
Antineoplastic Agents, Immunological / adverse effects
Antineoplastic Agents, Immunological / therapeutic use*
Biomarkers, Tumor
Breast Neoplasms / drug therapy*
Breast Neoplasms / etiology
Breast Neoplasms / metabolism
Breast Neoplasms / pathology*
Camptothecin / administration & dosage
Camptothecin / adverse effects
Camptothecin / analogs & derivatives*
Camptothecin / therapeutic use
Cell Adhesion Molecules / antagonists & inhibitors
Drug Resistance, Neoplasm
Female
Humans
Immunoconjugates / administration & dosage
Immunoconjugates / adverse effects
Immunoconjugates / therapeutic use*
Molecular Targeted Therapy
Neoplasm Metastasis
Neoplasm Staging
Receptor, ErbB-2 / antagonists & inhibitors
Retreatment
Treatment Outcome

Substances

Antibodies, Monoclonal, Humanized
Antigens, Neoplasm
Antineoplastic Agents, Immunological
Biomarkers, Tumor
Cell Adhesion Molecules
Immunoconjugates
TACSTD2 protein, human
Receptor, ErbB-2
sacituzumab govitecan
Camptothecin

Associated data

ClinicalTrials.gov/NCT03901339