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

Primary Purpose

Metastatic Breast Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sacituzumab Govitecan-hziy
Eribulin
Capecitabine
Gemcitabine
Vinorelbine
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 MBC including:

    • At least 1 prior anticancer hormonal treatment.
    • At least 1 cyclin-dependent kinase inhibitor 4/6 in the metastatic 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 hepatic function (bilirubin ≤ 1.5 institutional upper limit of normal (IULN), aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x IULN or 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
  • Individuals with Gilbert's disease.
  • Active serious infection requiring antibiotics
  • Individuals with a history of an anaphylactic reaction to irinotecan
  • Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
  • 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.

Sites / Locations

  • HonorHealth Research Institute
  • Arizona Oncology Associates, PC
  • Highlands Oncology Group
  • University of California, San Diego Moores Cancer Center
  • Los Angeles Hematology Oncology Medical Group
  • UCLA Department of Medicine - Hematology/Oncology
  • University of California, Irvine Medical Center-Chao Family Comprehensive Cancer Center
  • Southern California Permanente Medical Group
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Rocky Mountain Cancer Centers
  • University of Colorado
  • Yale University Cancer Center
  • Georgetown University Medical Center
  • University of Miami - Sylvester Comprehensive Cancer Center
  • Miami Cancer Institute
  • Orlando Health, Inc.
  • Moffitt Cancer Center
  • Emory University - Winship Cancer Institute
  • Northside Hospital, Inc.
  • University of Chicago Medical Center
  • The University of Kansas Cancer Center
  • James Graham Brown Cancer Center
  • Mercy Medical Center, Medical Oncology & Hematology
  • Maryland Oncology Hematology, P.A.
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute
  • Allina Health, Virginia Piper Cancer Institute
  • Masonic Cancer Center, University of Minnesota
  • Saint Luke's Cancer Institute
  • Washington University School of Medicine - Siteman Cancer Center
  • St. Vincent Frontier Cancer Center
  • Summit Medical Group
  • Rutgers Cancer Institute of New Jersey
  • New York Oncology Hematology, P.C.
  • Laura and Isaac Perlmutter Cancer Center/NYU Langone Health
  • Icahn School of Medicine at Mount Sinai
  • Columbia University Medical Center
  • Memorial Sloan Kettering Cancer Center
  • The Ohio State University
  • Thomas Jefferson University
  • Magee-Womens Hospital of UPMC
  • The West Clinic, PC dba West Cancer Center
  • Tennessee Oncology, PLLC
  • Vanderbilt University Medical Center
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center
  • University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
  • Texas Oncology-Denton South
  • Houston Methodist Hospital/Houston Methodist Cancer Center
  • Texas Oncology-Longview Cancer Center
  • UT Health San Antonio - Mays Cancer Center
  • Virginia Cancer Specialists
  • Virginia Oncology Associates
  • Oncology & Hematology Associates of Southwest Virginia, Inc. DBA Blue Ridge Cancer Care
  • Northwest Medical Specialties, PLLC
  • Chirec Cancer Institute
  • Institut Jules Bordet
  • Universitair Ziekenhuis Leuven
  • CHU UCL Namur/Site Sainte Elisabeth
  • Nova Scotia Cancer Centre
  • Centre Hospitalier de L'Universite de Montreal - Hôpital Notre-Dame
  • Centre Hospitalier Universitaire de Sherbrooke - Fleurimont
  • Hopital de Mercy
  • Institut Sainte Catherine
  • Hôpital Jean-Minjoz
  • Centre Georges-Francois Leclerc
  • Centre Leon Berard
  • Institut Régional du Cancer de Montpellier
  • Institut Curie
  • Hospices Civils de Lyon
  • Institut de Cancérologie Lucien Neuwirth
  • Institut Claudius Regaud
  • HELIOS Klinikum Berlin-Buch
  • Gynakologisches Zentrum Bonn
  • Marienhospital Bottrop
  • Städtisches Klinikum Dessau
  • Universitätsklinikum Erlangen
  • Kliniken Essen-Mitte
  • Centrum für Hämatologie und Onkologie Bethanien
  • Onkologische Schwerpunktpraxis Eppendorf
  • Gynakologisch-Onkologische Praxis Hannover
  • DIAKOVERE Krankenhaus gGmbH Henriettenstift - Standort Kirchrode
  • Nationales Centrum für Tumorerkrankungen - Heidelberg
  • Praxisklinik für Hämatologie und Onkologie Koblenz
  • Universitätsmedizin Mannheim
  • Klinikum Mutterhaus der Borromäerinnen
  • Azienda Ospedaliera Spedali Civili di Brescia
  • Ospedale di Desio
  • Ospedale Vito Fazzi di Lecce
  • Ospedale San Raffaele
  • Azienda Ospedaliera San Gerardo di Monza
  • Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
  • IFO Istituto Nazionale dei Tumori Regina Elena
  • Antoni van Leeuwenhoekziekenhuis
  • Medisch Centrum Haaglanden Antoniushove
  • Maastricht UMC+
  • Complejo Hospitalario Universitario A Coruna
  • Hospital Quirónsalud Barcelona Instituto Oncologico Baselga
  • Hospital Universitari Vall d'Hebron
  • Hospital de la Santa Creu I Sant Pau
  • Hospital Provincial de Castellón
  • Hospital Universitari Arnau de Vilanova
  • Hospital General Universitario Gregorio Maranon
  • Instituto Oncologico Bureau (IOB)
  • Hospital Universitario 12 de Octubre
  • Hospital Clinico Universitario de Santiago de Compostela
  • Hospital Universitario Virgen del Rocio
  • Royal Cornwall Hospital NHS Trust
  • Royal Surrey County Hospital
  • Leicester Royal Infirmary
  • Barts Health NHS Trust
  • The Royal Marsden NHS Foundation Trust
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sacituzumab Govitecan-hziy

Treatment of Physician's Choice (TPC)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause.
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).
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).
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.
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.
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.
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
Percentage of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs)
Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

Full Information

First Posted
March 26, 2019
Last Updated
July 17, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03901339
Brief Title
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
Acronym
TROPiCS-02
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
543 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sacituzumab Govitecan-hziy
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment of Physician's Choice (TPC)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sacituzumab Govitecan-hziy
Other Intervention Name(s)
IMMU-132, GS-0132
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Eribulin
Intervention Description
Administered intravenously per NCCN guidelines
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Administered orally per NCCN guidelines
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Administered intravenously per NCCN guidelines
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Intervention Description
Administered intravenously per NCCN guidelines
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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).
Time Frame
Up to approximately 3 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Up to approximately 3 years
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of death from any cause.
Time Frame
Up to approximately 5 years
Title
Duration of Response (DOR)
Description
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).
Time Frame
Up to approximately 3 years
Title
Clinical Benefit Rate (CBR)
Description
CBR is defined as best overall response of CR or PR or durable stable disease (duration of SD ≥ 6 months after randomization).
Time Frame
Up to approximately 3 years
Title
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)
Description
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.
Time Frame
Up to approximately 3 years
Title
TTD of Pain Score as Measured by EORTC QLQ-C30
Description
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.
Time Frame
Up to approximately 3 years
Title
TTD of Fatigue Score as Measured by EORTC QLQ-C30
Description
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.
Time Frame
Up to approximately 3 years
Title
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
Time Frame
Up to approximately 3 years
Title
Percentage of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame
Up to approximately 3 years
Title
Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities
Time Frame
Up to approximately 3 years
Title
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Time Frame
Baseline, Up to approximately 3 years

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25915780
Citation
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.
Results Reference
background
PubMed Identifier
25944802
Citation
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.
Results Reference
background
PubMed Identifier
26101915
Citation
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.
Results Reference
background
PubMed Identifier
30112436
Citation
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.
Results Reference
background
PubMed Identifier
29989029
Citation
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.
Results Reference
background
PubMed Identifier
29977989
Citation
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.
Results Reference
background
PubMed Identifier
28679770
Citation
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.
Results Reference
background
PubMed Identifier
28558150
Citation
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.
Results Reference
background
PubMed Identifier
28503956
Citation
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.
Results Reference
background
PubMed Identifier
28343977
Citation
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.
Results Reference
background
PubMed Identifier
28291390
Citation
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.
Results Reference
background
PubMed Identifier
28069724
Citation
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.
Results Reference
background
PubMed Identifier
27207776
Citation
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.
Results Reference
background
PubMed Identifier
26541586
Citation
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.
Results Reference
background
PubMed Identifier
26106073
Citation
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.
Results Reference
background
PubMed Identifier
36027558
Citation
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.
Results Reference
derived
PubMed Identifier
33093337
Citation
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.
Results Reference
derived
PubMed Identifier
32946924
Citation
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.
Results Reference
derived
PubMed Identifier
32223649
Citation
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.
Results Reference
derived
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=IMMU-132-09
Description
Gilead Clinical Trials Website

Learn more about this trial

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

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