Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer (TROPiCS-02)

Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens

The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Sacituzumab Govitecan-hziy; Drug: Eribulin; Drug: Capecitabine; Drug: Gemcitabine; Drug: Vinorelbine

• Study Type: Interventional
• Enrollment (Actual): 543
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Chirec Cancer Institute
  • Brussels, Belgium
    • Institut Jules Bordet
  • Leuven, Belgium
    • Universitair Ziekenhuis Leuven
  • Namur, Belgium
    • CHU UCL Namur/Site Sainte Elisabeth
• Canada
  • Montréal, Canada
    • Centre Hospitalier de L'Universite de Montreal - Hôpital Notre-Dame
  • Sherbrooke, Canada
    • Centre Hospitalier Universitaire de Sherbrooke - Fleurimont
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Cancer Centre
• France
  • Ars-Laquenexy, France, 57245
    • Hopital de Mercy
  • Avignon, France, 84918
    • Institut Sainte Catherine
  • Besançon, France, 25030
    • Hôpital Jean-Minjoz
  • Dijon, France, 21000
    • Centre Georges-François Leclerc
  • Lyon, France, 69008
    • Centre Leon Berard
  • Montpellier, France, 34298
    • Institut Regional du Cancer de Montpellier
  • Paris, France, 75005
    • Institut Curie
  • Pierre-Bénite, France, 69310
    • Hospices Civils de Lyon
  • Saint-Priest-en-Jarez, France, 42271
    • institut de cancérologie Lucien Neuwirth
  • Toulouse, France, 31300
    • Institut Claudius Regaud
• Germany
  • Berlin, Germany, 13125
    • Helios Klinikum Berlin-Buch
  • Bonn, Germany, 53111
    • Gynäkologisches Zentrum Bonn
  • Bottrop, Germany, 46236
    • Marienhospital Bottrop
  • Dessau, Germany, 06847
    • Städtisches Klinikum Dessau
  • Erlangen, Germany, 91054
    • Universitatsklinikum Erlangen
  • Essen, Germany, 45136
    • Kliniken Essen-Mitte
  • Frankfurt, Germany, 60389
    • Centrum fur Hamatologie und Onkologie Bethanien
  • Hamburg, Germany, 20249
    • Onkologische Schwerpunktpraxis Eppendorf
  • Hannover, Germany, 30177
    • Gynakologisch-Onkologische Praxis Hannover
  • Hannover, Germany
    • DIAKOVERE Krankenhaus gGmbH Henriettenstift - Standort Kirchrode
  • Heidelberg, Germany, 69120
    • Nationales Centrum für Tumorerkrankungen - Heidelberg
  • Koblenz, Germany, 56068
    • Praxisklinik für Hämatologie und Onkologie Koblenz
  • Mannheim, Germany, 68167
    • Universitätsmedizin Mannheim
  • Trier, Germany
    • Klinikum Mutterhaus der Borromäerinnen
• Italy
  • Brescia, Italy
    • Azienda Ospedaliera Spedali Civili di Brescia
  • Desio, Italy, 20832
    • Ospedale di Desio
  • Lecce, Italy
    • Ospedale Vito Fazzi di Lecce
  • Milano, Italy, 20132
    • Ospedale San Raffaele
  • Monza, Italy
    • Azienda Ospedaliera San Gerardo di Monza
  • Piacenza, Italy, 29121
    • Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
  • Rome, Italy, 00144
    • IFO Istituto Nazionale dei Tumori Regina Elena
• Netherlands
  • Amsterdam, Netherlands, 1066
    • Antoni Van Leeuwenhoekziekenhuis
  • Leidschendam, Netherlands
    • Medisch Centrum Haaglanden Antoniushove
  • Maastricht, Netherlands, 6229
    • Maastricht UMC+
• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08023
    • Hospital Quironsalud Barcelona Instituto Oncologico Baselga
  • Castillón, Spain, 12002
    • Hospital Provincial de Castellón
  • Lleida, Spain, 25198
    • Hospital Universitari Arnau de Vilanova
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28034
    • Instituto Oncologico Bureau (IOB)
  • Santiago De Compostela, Spain, 15706
    • Hospital Clinico Universitario de Santiago de Compostela
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
• United Kingdom
  • Cornwell, United Kingdom
    • Royal Cornwall Hospital NHS Trust
  • Guildford, United Kingdom, GU2 7XX
    • Royal Surrey County Hospital
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary
  • London, United Kingdom, EC1A 7BE
    • Barts Health NHS Trust
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • Manchester, United Kingdom
    • The Christie Nhs Foundation Trust
• United States
  • Arizona
    • Avondale, Arizona, United States, 85392
      • HonorHealth Research Institute
    • Tucson, Arizona, United States, 85704
      • Arizona Oncology Associates, PC
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group
  • California
    • La Jolla, California, United States, 92093
      • University of California, San Diego Moores Cancer Center
    • Los Angeles, California, United States, 90017
      • Los Angeles Hematology Oncology Medical Group
    • Los Angeles, California, United States, 90095
      • UCLA Department of Medicine - Hematology/Oncology
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center-Chao Family Comprehensive Cancer Center
    • San Diego, California, United States, 92120
      • Southern California Permanente Medical Group
    • San Francisco, California, United States, 94115
      • UCSF Helen Diller Family Comprehensive Cancer Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University Cancer Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Miami, Florida, United States, 33176
      • Miami Cancer Institute
    • Miami, Florida, United States, 33136
      • University of Miami - Sylvester Comprehensive Cancer Center
    • Orlando, Florida, United States, 32806
      • Orlando Health, Inc.
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University - Winship Cancer Institute
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • Kansas
    • Westwood, Kansas, United States, 66205
      • The University of Kansas Cancer Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • James Graham Brown Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center, Medical Oncology & Hematology
    • Rockville, Maryland, United States, 20850
      • Maryland Oncology Hematology, P.A.
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Allina Health, Virginia Piper Cancer Institute
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Cancer Institute
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine - Siteman Cancer Center
  • Montana
    • Billings, Montana, United States, 59102
      • St. Vincent Frontier Cancer Center
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Summit Medical Group
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Hematology, P.C.
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center/NYU Langone Health
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital of UPMC
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic, PC dba West Cancer Center
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology-Baylor Charles A. Sammons Cancer Center
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
    • Denton, Texas, United States, 76210
      • Texas Oncology-Denton South
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital/Houston Methodist Cancer Center
    • Longview, Texas, United States, 75601
      • Texas Oncology-Longview Cancer Center
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio - Mays Cancer Center
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Virginia Cancer Specialists
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Salem, Virginia, United States, 24153
      • Oncology & Hematology Associates of Southwest Virginia, Inc. DBA Blue Ridge Cancer Care
  • Washington
    • Tacoma, Washington, United States, 98405
      • NorthWest Medical Specialties, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Documented evidence of hormone receptor-positive human epidermal growth factor receptor 2 negative (HER2-negative) (hormonal receptor-positive (HR+)/HER2-) metastatic breast cancer (MBC) confirmed.

• Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for metastatic disease:

  • At least 1 taxane in any setting.
  • At least 1 prior anticancer hormonal treatment in any setting.
  • At least 1 cyclin-dependent kinase inhibitor 4/6 in any setting.
• Eligible for one of the chemotherapy options listed in the TPC arm.
• Documented disease progression after the most recent therapy.
• Adequate bone marrow function (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500 per mm^3, platelets ≥ 100,000 per mm^3).
• Adequate renal function: calculated creatinine clearance ≥ 30 mL/minute according to the Cockcroft and Gault formula .
• Adequate liver function (bilirubin ≤ 1.5 institutional upper limit of normal (IULN), or ≤ 3 IULN for individuals with documented Gilbert's syndrome, aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x IULN (in the case of liver metastases ≤ 5.0 x IULN)).
• Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin (ß-hCG)).

Key Exclusion Criteria:

• Previous treatment with topoisomerase 1 Inhibitors as a free form or as other formulations.
• History of significant cardiovascular disease or clinically significant electrocardiogram (ECG) abnormality.
• Active serious infection requiring antibiotics.
• Any medical or other condition which, in the opinion of the Investigator, causes the individual to be medically unfit to receive sacituzumab govitecan or unsuitable for any reason.
• Locally advanced MBC (stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacituzumab Govitecan-hziy; Participants will receive sacituzumab govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 of a 21-day cycle.	Drug: Sacituzumab Govitecan-hziy; Administered intravenously; Other Names: IMMU-132; GS-0132
Active Comparator: Treatment of Physician's Choice (TPC); Participants will receive TPC determined prior to randomization from one of the following single-agent treatment: Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic); Eribulin: 1.4 mg/m^2 for North American sites, 1.23 mg/m^2 for European sites) via IV on Days 1 and 8 of a 21-day cycle; Capecitabine: 1000-1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period given as a 21-day cycle; Gemcitabine: 800-1200 mg/m^2 via IV on Days 1, 8, and 15 of each 28-day cycle or per institution; Vinorelbine: 25 mg/m^2 via IV on Day 1 weekly cycle per institution	Drug: Eribulin; Administered intravenously per NCCN guidelines; Drug: Capecitabine; Administered orally per NCCN guidelines; Drug: Gemcitabine; Administered intravenously per NCCN guidelines; Drug: Vinorelbine; Administered intravenously per NCCN guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	PFS is defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurs first) according to blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).	Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR is defined as the proportion of participants who have a best overall response of either Complete Remission (CR) or Partial Response (PR) that is confirmed ≥ 4 weeks later according to BICR using RECIST 1.1.	Up to approximately 3 years
Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of death from any cause.	Up to approximately 5 years
Duration of Response (DOR)	DOR is defined as the time from the date a response was first documented until the date of the first documentation of disease progression or date of death (whichever occurs first).	Up to approximately 3 years
Clinical Benefit Rate (CBR)	CBR is defined as best overall response of CR or PR or durable stable disease (duration of SD ≥ 6 months after randomization).	Up to approximately 3 years
Time to Deterioration (TTD) of Global Health Status/Quality of Life (QoL) Scale as Measured by European Organization for Research and Treatment of Cancer Quality of Life for Cancer Patients, Core Questionnaire Version 3.0 (EORTC QLQ-C30)	The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant). Deterioration is defined as greater than or equal to 10 points worsening from baseline in the global health status/QoL scale.	Up to approximately 3 years
TTD of Pain Score as Measured by EORTC QLQ-C30	The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant). Deterioration is defined as greater than or equal to 10 points worsening from baseline in the pain score.	Up to approximately 3 years
TTD of Fatigue Score as Measured by EORTC QLQ-C30	The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant). Deterioration is defined as greater than or equal to 10 points worsening from baseline in the fatigue score.	Up to approximately 3 years
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)		Up to approximately 3 years
Percentage of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs)		Up to approximately 3 years
Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities		Up to approximately 3 years
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status		Baseline, Up to approximately 3 years

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

General Publications

• Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Arrojo R, Liu D, Rossi EA, Chang CH, Goldenberg DM. Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2/SN-38 Antibody-Drug Conjugate: Characterization and Efficacy in Pancreatic, Gastric, and Other Cancers. Bioconjug Chem. 2015 May 20;26(5):919-31. doi: 10.1021/acs.bioconjchem.5b00223. Epub 2015 May 8.
• Starodub AN, Ocean AJ, Shah MA, Guarino MJ, Picozzi VJ Jr, Vahdat LT, Thomas SS, Govindan SV, Maliakal PP, Wegener WA, Hamburger SA, Sharkey RM, Goldenberg DM. First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. Clin Cancer Res. 2015 Sep 1;21(17):3870-8. doi: 10.1158/1078-0432.CCR-14-3321. Epub 2015 May 5.
• Goldenberg DM, Cardillo TM, Govindan SV, Rossi EA, Sharkey RM. Trop-2 is a novel target for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-drug conjugate (ADC). Oncotarget. 2015 Sep 8;6(26):22496-512. doi: 10.18632/oncotarget.4318. Erratum In: Oncotarget. 2020 Mar 10;11(10):942.
• Vlachostergios PJ, Jakubowski CD, Niaz MJ, Lee A, Thomas C, Hackett AL, Patel P, Rashid N, Tagawa ST. Antibody-Drug Conjugates in Bladder Cancer. Bladder Cancer. 2018 Jul 30;4(3):247-259. doi: 10.3233/BLC-180169.
• Goldenberg DM, Stein R, Sharkey RM. The emergence of trophoblast cell-surface antigen 2 (TROP-2) as a novel cancer target. Oncotarget. 2018 Jun 22;9(48):28989-29006. doi: 10.18632/oncotarget.25615. eCollection 2018 Jun 22.
• Han C, Bellone S, Schwartz PE, Govindan SV, Sharkey RM, Goldenberg DM, Santin AD. Sacituzumab Govitecan (IMMU-132) in treatment-resistant uterine serous carcinoma: A case report. Gynecol Oncol Rep. 2018 May 23;25:37-40. doi: 10.1016/j.gore.2018.05.009. eCollection 2018 Aug.
• Gray JE, Heist RS, Starodub AN, Camidge DR, Kio EA, Masters GA, Purcell WT, Guarino MJ, Misleh J, Schneider CJ, Schneider BJ, Ocean A, Johnson T, Gandhi L, Kalinsky K, Scheff R, Messersmith WA, Govindan SV, Maliakal PP, Mudenda B, Wegener WA, Sharkey RM, Goldenberg DM. Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan. Clin Cancer Res. 2017 Oct 1;23(19):5711-5719. doi: 10.1158/1078-0432.CCR-17-0933. Epub 2017 Jul 5.
• Ocean AJ, Starodub AN, Bardia A, Vahdat LT, Isakoff SJ, Guarino M, Messersmith WA, Picozzi VJ, Mayer IA, Wegener WA, Maliakal P, Govindan SV, Sharkey RM, Goldenberg DM. Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: Safety and pharmacokinetics. Cancer. 2017 Oct 1;123(19):3843-3854. doi: 10.1002/cncr.30789. Epub 2017 May 30.
• Sahota S, Vahdat LT. Sacituzumab govitecan: an antibody-drug conjugate. Expert Opin Biol Ther. 2017 Aug;17(8):1027-1031. doi: 10.1080/14712598.2017.1331214. Epub 2017 May 22.
• Burki TK. Sacituzumab govitecan activity in advanced breast cancer. Lancet Oncol. 2017 May;18(5):e246. doi: 10.1016/S1470-2045(17)30232-2. Epub 2017 Mar 23. No abstract available.
• Bardia A, Mayer IA, Diamond JR, Moroose RL, Isakoff SJ, Starodub AN, Shah NC, O'Shaughnessy J, Kalinsky K, Guarino M, Abramson V, Juric D, Tolaney SM, Berlin J, Messersmith WA, Ocean AJ, Wegener WA, Maliakal P, Sharkey RM, Govindan SV, Goldenberg DM, Vahdat LT. Efficacy and Safety of Anti-Trop-2 Antibody Drug Conjugate Sacituzumab Govitecan (IMMU-132) in Heavily Pretreated Patients With Metastatic Triple-Negative Breast Cancer. J Clin Oncol. 2017 Jul 1;35(19):2141-2148. doi: 10.1200/JCO.2016.70.8297. Epub 2017 Mar 14.
• Cardillo TM, Sharkey RM, Rossi DL, Arrojo R, Mostafa AA, Goldenberg DM. Synthetic Lethality Exploitation by an Anti-Trop-2-SN-38 Antibody-Drug Conjugate, IMMU-132, Plus PARP Inhibitors in BRCA1/2-wild-type Triple-Negative Breast Cancer. Clin Cancer Res. 2017 Jul 1;23(13):3405-3415. doi: 10.1158/1078-0432.CCR-16-2401. Epub 2017 Jan 9.
• Chang CH, Wang Y, Zalath M, Liu D, Cardillo TM, Goldenberg DM. Combining ABCG2 Inhibitors with IMMU-132, an Anti-Trop-2 Antibody Conjugate of SN-38, Overcomes Resistance to SN-38 in Breast and Gastric Cancers. Mol Cancer Ther. 2016 Aug;15(8):1910-9. doi: 10.1158/1535-7163.MCT-16-0219. Epub 2016 May 20.
• Faltas B, Goldenberg DM, Ocean AJ, Govindan SV, Wilhelm F, Sharkey RM, Hajdenberg J, Hodes G, Nanus DM, Tagawa ST. Sacituzumab Govitecan, a Novel Antibody--Drug Conjugate, in Patients With Metastatic Platinum-Resistant Urothelial Carcinoma. Clin Genitourin Cancer. 2016 Feb;14(1):e75-9. doi: 10.1016/j.clgc.2015.10.002. Epub 2015 Oct 19.
• Sharkey RM, McBride WJ, Cardillo TM, Govindan SV, Wang Y, Rossi EA, Chang CH, Goldenberg DM. Enhanced Delivery of SN-38 to Human Tumor Xenografts with an Anti-Trop-2-SN-38 Antibody Conjugate (Sacituzumab Govitecan). Clin Cancer Res. 2015 Nov 15;21(22):5131-8. doi: 10.1158/1078-0432.CCR-15-0670. Epub 2015 Jun 23.
• Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Pardo PG, Jhaveri KL, Delaney R, Fu O, Lin L, Verret W, Tolaney SM. Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. J Clin Oncol. 2022 Oct 10;40(29):3365-3376. doi: 10.1200/JCO.22.01002. Epub 2022 Aug 26.
• McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671.
• Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O'Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldenberg DM, Sharkey RM, Maliakal P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020 Dec;31(12):1709-1718. doi: 10.1016/j.annonc.2020.09.004. Epub 2020 Sep 15.
• Rugo HS, Bardia A, Tolaney SM, Arteaga C, Cortes J, Sohn J, Marme F, Hong Q, Delaney RJ, Hafeez A, Andre F, Schmid P. 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.

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Actual): October 20, 2023
• Study Completion (Actual): October 20, 2023

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Immunoconjugates; Capecitabine; Vinorelbine; Gemcitabine; Sacituzumab govitecan
• Other Study ID Numbers: IMMU-132-09; 2018-004201-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
• IPD Sharing Time Frame: 18 months after study completion
• IPD Sharing Access Criteria: A secured external environment with username, password, and RSA code.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No