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

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

Research output: Contribution to journal › Article › peer-review

75 Scopus citations

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.

Original language	English (US)
Pages (from-to)	705-712
Number of pages	8
Journal	Future Oncology
Volume	16
Issue number	12
DOIs	https://doi.org/10.2217/fon-2020-0163
State	Published - Apr 2020

Keywords

HER2-negative
HR-positive
MBC
SN-38
Trop-2
antibody-drug conjugate
metastatic breast cancer
sacituzumab govitecan

ASJC Scopus subject areas

Oncology
Cancer Research

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

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",

author = "Rugo, {Hope S.} and Aditya Bardia and Tolaney, {Sara M.} and Carlos Arteaga and Javier Cortes and Joohyuk Sohn and Frederik Marm{\'e} and Quan Hong and Delaney, {Rosemary J.} and Amir Hafeez and Fabrice Andr{\'e} and Peter Schmid",

note = "Publisher Copyright: {\textcopyright} 2020 Hope S. Rugo, MD.",

year = "2020",

month = apr,

doi = "10.2217/fon-2020-0163",

language = "English (US)",

volume = "16",

pages = "705--712",

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AU - Bardia, Aditya

AU - Tolaney, Sara M.

AU - Arteaga, Carlos

AU - Cortes, Javier

AU - Sohn, Joohyuk

AU - Marmé, Frederik

AU - Hong, Quan

AU - Delaney, Rosemary J.

AU - Hafeez, Amir

AU - André, Fabrice

AU - Schmid, Peter

PY - 2020/4

Y1 - 2020/4

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AB - 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.

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KW - HR-positive

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KW - Trop-2

KW - antibody-drug conjugate

KW - metastatic breast cancer

KW - sacituzumab govitecan

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

Abstract

Keywords

ASJC Scopus subject areas

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