JOURNAL ONKOLOGIE – STUDIE
Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02)
Rekrutierend
NCT-Nummer:
NCT03901339
Studienbeginn:
Mai 2019
Letztes Update:
29.09.2020
Wirkstoff:
Sacituzumab govitecan, Eribulin, Capecitabine, Gemcitabine, Vinorelbine
Indikation (Clinical Trials):
Breast Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 3
Sponsor:
Immunomedics, Inc.
Collaborator:
-
Studienleiter
Study Director
Immunomedics, Inc.
Kontakt
Kontakt:
Phone: 888.983.4668
E-Mail: medinfo@immunomedics.com» Kontaktdaten anzeigen
Studienlocations (3 von 105)
HELIOS Klinikum Berlin-Buch
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-MapsGynakologisches Zentrum Bonn
53111 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-MapsBrustzentrum Marienhospital Bottrop
Josef-Albers-Straße 70
46236 Bottrop
DeutschlandRekrutierend» Google-Maps
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-MapsGynakologisches Zentrum Bonn
53111 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-MapsBrustzentrum Marienhospital Bottrop
Josef-Albers-Straße 70
46236 Bottrop
DeutschlandRekrutierend» Google-Maps
Städtisches Klinikum Dessau
06847 Dessau
(Sachsen-Anhalt)
GermanyRekrutierend» Google-MapsHautkrebszentrum Universitätsklinikum Erlangen
Ulmenweg 18
91054 Erlangen
(Bayern)
DeutschlandRekrutierend» Google-MapsInterdisziplinäres Brustkrebszentrum Kliniken Essen-Mitte
Henricistraße 92
45136 Essen
(Nordrhein-Westfalen)
DeutschlandRekrutierend» Google-MapsCentrum für Hämatologie und Onkologie Bethanien
60389 Frankfurt
(Hessen)
GermanyRekrutierend» Google-MapsOnkologische Schwerpunktpraxis Eppendorf
20249 Hamburg
(Hamburg)
GermanyRekrutierend» Google-MapsGynakologisch-Onkologische Praxis Hannover
30177 Hannover
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-MapsNationales Centrum für Tumorerkrankungen - Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-MapsPraxisklinik für Hämatologie und Onkologie Koblenz
56068 Koblenz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-MapsKopf-Hals-Tumorzentrum der Universitätsmedizin Mannheim
68167 Mannheim
DeutschlandRekrutierend» Google-MapsHonorHealth Research Institute
85392 Avondale
United StatesAktiv, nicht rekrutierend» Google-MapsArizona Oncology Associates, PC
85704 Tucson
United StatesRekrutierend» Google-MapsHighlands Oncology Group
72703 Fayetteville
United StatesRekrutierend» Google-MapsUniversity of California, San Diego Moores Cancer Center
92093 La Jolla
United StatesRekrutierend» Google-MapsLos Angeles Hematology Oncology Medical Group
90017 Los Angeles
United StatesAktiv, nicht rekrutierend» Google-MapsUCLA Department of Medicine - Hematology/Oncology
90095 Los Angeles
United StatesRekrutierend» Google-MapsUniversity of California, Irvine Medical Center-Chao Family Comprehensive Cancer Center
92868 Orange
United StatesRekrutierend» Google-MapsSouthern California Permanente Medical Group
92120 San Diego
United StatesRekrutierend» Google-MapsUCSF Helen Diller Family Comprehensive Cancer Center
94115 San Francisco
United StatesRekrutierend» Google-MapsRocky Mountain Cancer Centers
80012 Aurora
United StatesRekrutierend» Google-MapsUniversity of Colorado
80045 Aurora
United StatesRekrutierend» Google-MapsYale University Cancer Center
06520 New Haven
United StatesRekrutierend» Google-MapsGeorgetown University Medical Center
20007 Washington
United StatesRekrutierend» Google-MapsUniversity of Miami - Sylvester Comprehensive Cancer Center
33136 Miami
United StatesRekrutierend» Google-MapsMiami Cancer Institute
33176 Miami
United StatesRekrutierend» Google-MapsOrlando Health, Inc.
32806 Orlando
United StatesRekrutierend» Google-MapsMoffitt Cancer Center
33612 Tampa
United StatesAktiv, nicht rekrutierend» Google-MapsEmory University - Winship Cancer Institute
30322 Atlanta
United StatesRekrutierend» Google-MapsNorthside Hospital, Inc.
30342 Atlanta
United StatesRekrutierend» Google-MapsUniversity of Chicago Medical Center
60637 Chicago
United StatesRekrutierend» Google-MapsThe University of Kansas Cancer Center
66205 Westwood
United StatesRekrutierend» Google-MapsJames Graham Brown Cancer Center
40202 Louisville
United StatesRekrutierend» Google-MapsMercy Medical Center, Medical Oncology & Hematology
21202 Baltimore
United StatesRekrutierend» Google-MapsMaryland Oncology Hematology, P.A.
20850 Rockville
United StatesRekrutierend» Google-MapsMassachusetts General Hospital
02114 Boston
United StatesRekrutierend» Google-MapsBeth Israel Deaconess Medical Center
02215 Boston
United StatesRekrutierend» Google-MapsDana Farber Cancer Institute
02215 Boston
United StatesRekrutierend» Google-MapsAllina Health, Virginia Piper Cancer Institute
55407 Minneapolis
United StatesRekrutierend» Google-MapsMasonic Cancer Center, University of Minnesota
55455 Minneapolis
United StatesRekrutierend» Google-MapsSaint Luke's Cancer Institute
64111 Kansas City
United StatesRekrutierend» Google-MapsWashington University School of Medicine - Siteman Cancer Center
63110 Saint Louis
United StatesRekrutierend» Google-MapsSt. Vincent Frontier Cancer Center
59102 Billings
United StatesRekrutierend» Google-MapsSummit Medical Group
07932 Florham Park
United StatesRekrutierend» Google-MapsRutgers Cancer Institute of New Jersey
08903 New Brunswick
United StatesRekrutierend» Google-MapsNew York Oncology Hematology, P.C.
12206 Albany
United StatesRekrutierend» Google-MapsLaura and Isaac Perlmutter Cancer Center/NYU Langone Health
10016 New York
United StatesRekrutierend» Google-MapsIcahn School of Medicine at Mount Sinai
10029 New York
United StatesRekrutierend» Google-MapsColumbia University Medical Center
10032 New York
United StatesRekrutierend» Google-MapsMemorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-MapsThe Ohio State University
43210 Columbus
United StatesRekrutierend» Google-MapsThomas Jefferson University
19107 Philadelphia
United StatesRekrutierend» Google-MapsMagee-Womens Hospital of UPMC
15213 Pittsburgh
United StatesRekrutierend» Google-MapsThe West Clinic, PC dba West Cancer Center
38138 Germantown
United StatesRekrutierend» Google-MapsTennessee Oncology, PLLC
37203 Nashville
United StatesRekrutierend» Google-MapsVanderbilt University Medical Center
37232 Nashville
United StatesRekrutierend» Google-MapsTexas Oncology-Baylor Charles A. Sammons Cancer Center
75246 Dallas
United StatesRekrutierend» Google-MapsUniversity of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
75390 Dallas
United StatesRekrutierend» Google-MapsTexas Oncology-Denton South
76210 Denton
United StatesRekrutierend» Google-MapsHouston Methodist Hospital/Houston Methodist Cancer Center
77030 Houston
United StatesRekrutierend» Google-MapsTexas Oncology-Longview Cancer Center
75601 Longview
United StatesRekrutierend» Google-MapsUT Health San Antonio - Mays Cancer Center
78229 San Antonio
United StatesRekrutierend» Google-MapsVirginia Cancer Specialists
22205 Arlington
United StatesRekrutierend» Google-MapsVirginia Oncology Associates
23502 Norfolk
United StatesRekrutierend» Google-MapsOncology & Hematology Associates of Southwest Virginia, Inc. DBA Blue Ridge Cancer Care
24153 Salem
United StatesRekrutierend» Google-MapsNorthwest Medical Specialties, PLLC
98405 Tacoma
United StatesRekrutierend» Google-MapsChirec Cancer Institute
Brussels
BelgiumRekrutierend» Google-MapsInstitut Jules Bordet
Brussels
BelgiumRekrutierend» Google-MapsUniversitair Ziekenhuis Leuven
Leuven
BelgiumRekrutierend» Google-MapsCHU UCL Namur/Site Sainte Elisabeth
Namur
BelgiumRekrutierend» Google-MapsNova Scotia Cancer Centre
B3H 1V7 Halifax
CanadaAktiv, nicht rekrutierend» Google-MapsHopital de Mercy
57245 Ars-Laquenexy
FranceRekrutierend» Google-MapsInstitut Sainte Catherine
84918 Avignon
FranceRekrutierend» Google-MapsHôpital Jean-Minjoz
25030 Besançon
FranceRekrutierend» Google-MapsCentre Georges-Francois Leclerc
21000 Dijon
FranceRekrutierend» Google-MapsCentre Leon Berard
69008 Lyon
FranceRekrutierend» Google-MapsInstitut Régional du Cancer de Montpellier
34298 Montpellier
FranceRekrutierend» Google-MapsInstitut Curie
75005 Paris
FranceRekrutierend» Google-MapsHospices Civils de Lyon
69310 Pierre-Bénite
FranceRekrutierend» Google-MapsInstitut de Cancérologie Lucien Neuwirth
42271 Saint-Priest-en-Jarez
FranceRekrutierend» Google-MapsInstitut Claudius Regaud
31300 Toulouse
FranceRekrutierend» Google-MapsOspedale di Desio
20832 Desio
ItalyRekrutierend» Google-MapsOspedale San Raffaele
20132 Milano
ItalyRekrutierend» Google-MapsAzienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
29121 Piacenza
ItalyRekrutierend» Google-MapsIFO Istituto Nazionale dei Tumori Regina Elena
00144 Rome
ItalyRekrutierend» Google-MapsAntoni van Leeuwenhoekziekenhuis
1066 Amsterdam
NetherlandsRekrutierend» Google-MapsMaastricht UMC+
6229 Maastricht
NetherlandsRekrutierend» Google-MapsComplejo Hospitalario Universitario A Coruna
15006 A Coruña
SpainRekrutierend» Google-MapsHospital Quirónsalud Barcelona Instituto Oncologico Baselga
08023 Barcelona
SpainRekrutierend» Google-MapsHospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-MapsHospital de la Santa Creu I Sant Pau
08041 Barcelona
SpainRekrutierend» Google-MapsHospital Provincial de Castellón
12002 Castillón
SpainRekrutierend» Google-MapsHospital Universitari Arnau de Vilanova
25198 Lleida
SpainRekrutierend» Google-MapsHospital General Universitario Gregorio Maranon
28007 Madrid
SpainRekrutierend» Google-MapsInstituto Oncologico Bureau (IOB)
28034 Madrid
SpainRekrutierend» Google-MapsHospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-MapsHospital Clinico Universitario de Santiago de Compostela
15706 Santiago De Compostela
SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario Virgen del Rocio
41013 Sevilla
SpainRekrutierend» Google-MapsRoyal Cornwall Hospital NHS Trust
Cornwell
United KingdomRekrutierend» Google-MapsRoyal Surrey County Hospital
GU2 7XX Guildford
United KingdomAktiv, nicht rekrutierend» Google-MapsLeicester Royal Infirmary
LE1 5WW Leicester
United KingdomRekrutierend» Google-MapsBarts Health NHS Trust
EC1A 7BE London
United KingdomRekrutierend» Google-MapsThe Royal Marsden NHS Foundation Trust
SW3 6JJ London
United KingdomRekrutierend» Google-MapsThe Christie NHS Foundation Trust
Manchester
United KingdomRekrutierend» Google-Maps
Alle anzeigen 06847 Dessau
(Sachsen-Anhalt)
GermanyRekrutierend» Google-MapsHautkrebszentrum Universitätsklinikum Erlangen
Ulmenweg 18
91054 Erlangen
(Bayern)
DeutschlandRekrutierend» Google-MapsInterdisziplinäres Brustkrebszentrum Kliniken Essen-Mitte
Henricistraße 92
45136 Essen
(Nordrhein-Westfalen)
DeutschlandRekrutierend» Google-MapsCentrum für Hämatologie und Onkologie Bethanien
60389 Frankfurt
(Hessen)
GermanyRekrutierend» Google-MapsOnkologische Schwerpunktpraxis Eppendorf
20249 Hamburg
(Hamburg)
GermanyRekrutierend» Google-MapsGynakologisch-Onkologische Praxis Hannover
30177 Hannover
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-MapsNationales Centrum für Tumorerkrankungen - Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-MapsPraxisklinik für Hämatologie und Onkologie Koblenz
56068 Koblenz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-MapsKopf-Hals-Tumorzentrum der Universitätsmedizin Mannheim
68167 Mannheim
DeutschlandRekrutierend» Google-MapsHonorHealth Research Institute
85392 Avondale
United StatesAktiv, nicht rekrutierend» Google-MapsArizona Oncology Associates, PC
85704 Tucson
United StatesRekrutierend» Google-MapsHighlands Oncology Group
72703 Fayetteville
United StatesRekrutierend» Google-MapsUniversity of California, San Diego Moores Cancer Center
92093 La Jolla
United StatesRekrutierend» Google-MapsLos Angeles Hematology Oncology Medical Group
90017 Los Angeles
United StatesAktiv, nicht rekrutierend» Google-MapsUCLA Department of Medicine - Hematology/Oncology
90095 Los Angeles
United StatesRekrutierend» Google-MapsUniversity of California, Irvine Medical Center-Chao Family Comprehensive Cancer Center
92868 Orange
United StatesRekrutierend» Google-MapsSouthern California Permanente Medical Group
92120 San Diego
United StatesRekrutierend» Google-MapsUCSF Helen Diller Family Comprehensive Cancer Center
94115 San Francisco
United StatesRekrutierend» Google-MapsRocky Mountain Cancer Centers
80012 Aurora
United StatesRekrutierend» Google-MapsUniversity of Colorado
80045 Aurora
United StatesRekrutierend» Google-MapsYale University Cancer Center
06520 New Haven
United StatesRekrutierend» Google-MapsGeorgetown University Medical Center
20007 Washington
United StatesRekrutierend» Google-MapsUniversity of Miami - Sylvester Comprehensive Cancer Center
33136 Miami
United StatesRekrutierend» Google-MapsMiami Cancer Institute
33176 Miami
United StatesRekrutierend» Google-MapsOrlando Health, Inc.
32806 Orlando
United StatesRekrutierend» Google-MapsMoffitt Cancer Center
33612 Tampa
United StatesAktiv, nicht rekrutierend» Google-MapsEmory University - Winship Cancer Institute
30322 Atlanta
United StatesRekrutierend» Google-MapsNorthside Hospital, Inc.
30342 Atlanta
United StatesRekrutierend» Google-MapsUniversity of Chicago Medical Center
60637 Chicago
United StatesRekrutierend» Google-MapsThe University of Kansas Cancer Center
66205 Westwood
United StatesRekrutierend» Google-MapsJames Graham Brown Cancer Center
40202 Louisville
United StatesRekrutierend» Google-MapsMercy Medical Center, Medical Oncology & Hematology
21202 Baltimore
United StatesRekrutierend» Google-MapsMaryland Oncology Hematology, P.A.
20850 Rockville
United StatesRekrutierend» Google-MapsMassachusetts General Hospital
02114 Boston
United StatesRekrutierend» Google-MapsBeth Israel Deaconess Medical Center
02215 Boston
United StatesRekrutierend» Google-MapsDana Farber Cancer Institute
02215 Boston
United StatesRekrutierend» Google-MapsAllina Health, Virginia Piper Cancer Institute
55407 Minneapolis
United StatesRekrutierend» Google-MapsMasonic Cancer Center, University of Minnesota
55455 Minneapolis
United StatesRekrutierend» Google-MapsSaint Luke's Cancer Institute
64111 Kansas City
United StatesRekrutierend» Google-MapsWashington University School of Medicine - Siteman Cancer Center
63110 Saint Louis
United StatesRekrutierend» Google-MapsSt. Vincent Frontier Cancer Center
59102 Billings
United StatesRekrutierend» Google-MapsSummit Medical Group
07932 Florham Park
United StatesRekrutierend» Google-MapsRutgers Cancer Institute of New Jersey
08903 New Brunswick
United StatesRekrutierend» Google-MapsNew York Oncology Hematology, P.C.
12206 Albany
United StatesRekrutierend» Google-MapsLaura and Isaac Perlmutter Cancer Center/NYU Langone Health
10016 New York
United StatesRekrutierend» Google-MapsIcahn School of Medicine at Mount Sinai
10029 New York
United StatesRekrutierend» Google-MapsColumbia University Medical Center
10032 New York
United StatesRekrutierend» Google-MapsMemorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-MapsThe Ohio State University
43210 Columbus
United StatesRekrutierend» Google-MapsThomas Jefferson University
19107 Philadelphia
United StatesRekrutierend» Google-MapsMagee-Womens Hospital of UPMC
15213 Pittsburgh
United StatesRekrutierend» Google-MapsThe West Clinic, PC dba West Cancer Center
38138 Germantown
United StatesRekrutierend» Google-MapsTennessee Oncology, PLLC
37203 Nashville
United StatesRekrutierend» Google-MapsVanderbilt University Medical Center
37232 Nashville
United StatesRekrutierend» Google-MapsTexas Oncology-Baylor Charles A. Sammons Cancer Center
75246 Dallas
United StatesRekrutierend» Google-MapsUniversity of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
75390 Dallas
United StatesRekrutierend» Google-MapsTexas Oncology-Denton South
76210 Denton
United StatesRekrutierend» Google-MapsHouston Methodist Hospital/Houston Methodist Cancer Center
77030 Houston
United StatesRekrutierend» Google-MapsTexas Oncology-Longview Cancer Center
75601 Longview
United StatesRekrutierend» Google-MapsUT Health San Antonio - Mays Cancer Center
78229 San Antonio
United StatesRekrutierend» Google-MapsVirginia Cancer Specialists
22205 Arlington
United StatesRekrutierend» Google-MapsVirginia Oncology Associates
23502 Norfolk
United StatesRekrutierend» Google-MapsOncology & Hematology Associates of Southwest Virginia, Inc. DBA Blue Ridge Cancer Care
24153 Salem
United StatesRekrutierend» Google-MapsNorthwest Medical Specialties, PLLC
98405 Tacoma
United StatesRekrutierend» Google-MapsChirec Cancer Institute
Brussels
BelgiumRekrutierend» Google-MapsInstitut Jules Bordet
Brussels
BelgiumRekrutierend» Google-MapsUniversitair Ziekenhuis Leuven
Leuven
BelgiumRekrutierend» Google-MapsCHU UCL Namur/Site Sainte Elisabeth
Namur
BelgiumRekrutierend» Google-MapsNova Scotia Cancer Centre
B3H 1V7 Halifax
CanadaAktiv, nicht rekrutierend» Google-MapsHopital de Mercy
57245 Ars-Laquenexy
FranceRekrutierend» Google-MapsInstitut Sainte Catherine
84918 Avignon
FranceRekrutierend» Google-MapsHôpital Jean-Minjoz
25030 Besançon
FranceRekrutierend» Google-MapsCentre Georges-Francois Leclerc
21000 Dijon
FranceRekrutierend» Google-MapsCentre Leon Berard
69008 Lyon
FranceRekrutierend» Google-MapsInstitut Régional du Cancer de Montpellier
34298 Montpellier
FranceRekrutierend» Google-MapsInstitut Curie
75005 Paris
FranceRekrutierend» Google-MapsHospices Civils de Lyon
69310 Pierre-Bénite
FranceRekrutierend» Google-MapsInstitut de Cancérologie Lucien Neuwirth
42271 Saint-Priest-en-Jarez
FranceRekrutierend» Google-MapsInstitut Claudius Regaud
31300 Toulouse
FranceRekrutierend» Google-MapsOspedale di Desio
20832 Desio
ItalyRekrutierend» Google-MapsOspedale San Raffaele
20132 Milano
ItalyRekrutierend» Google-MapsAzienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
29121 Piacenza
ItalyRekrutierend» Google-MapsIFO Istituto Nazionale dei Tumori Regina Elena
00144 Rome
ItalyRekrutierend» Google-MapsAntoni van Leeuwenhoekziekenhuis
1066 Amsterdam
NetherlandsRekrutierend» Google-MapsMaastricht UMC+
6229 Maastricht
NetherlandsRekrutierend» Google-MapsComplejo Hospitalario Universitario A Coruna
15006 A Coruña
SpainRekrutierend» Google-MapsHospital Quirónsalud Barcelona Instituto Oncologico Baselga
08023 Barcelona
SpainRekrutierend» Google-MapsHospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-MapsHospital de la Santa Creu I Sant Pau
08041 Barcelona
SpainRekrutierend» Google-MapsHospital Provincial de Castellón
12002 Castillón
SpainRekrutierend» Google-MapsHospital Universitari Arnau de Vilanova
25198 Lleida
SpainRekrutierend» Google-MapsHospital General Universitario Gregorio Maranon
28007 Madrid
SpainRekrutierend» Google-MapsInstituto Oncologico Bureau (IOB)
28034 Madrid
SpainRekrutierend» Google-MapsHospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-MapsHospital Clinico Universitario de Santiago de Compostela
15706 Santiago De Compostela
SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario Virgen del Rocio
41013 Sevilla
SpainRekrutierend» Google-MapsRoyal Cornwall Hospital NHS Trust
Cornwell
United KingdomRekrutierend» Google-MapsRoyal Surrey County Hospital
GU2 7XX Guildford
United KingdomAktiv, nicht rekrutierend» Google-MapsLeicester Royal Infirmary
LE1 5WW Leicester
United KingdomRekrutierend» Google-MapsBarts Health NHS Trust
EC1A 7BE London
United KingdomRekrutierend» Google-MapsThe Royal Marsden NHS Foundation Trust
SW3 6JJ London
United KingdomRekrutierend» Google-MapsThe Christie NHS Foundation Trust
Manchester
United KingdomRekrutierend» Google-Maps
Studien-Informationen
Detailed Description:Approximately 400 eligible subjects will be randomized to one of the following 2 treatment arms:
Investigational Arm:
Sacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle).
Control Arm:
Recommended doses and schedules as per NCCN guidelines (with dose modifications if too toxic).
Eribulin; Capecitabine; Gemcitabine; Vinorelbine
Ein-/Ausschlusskriterien
Inclusion Criteria:- Female or male subjects aged ≥18 years at the time of signing the informed consent form
- Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) 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, ANC > 1,500 per mm3, platelets > 100,000 per mm3).
- Adequate renal function: calculated creatinine clearance ≥30 mL/minute according to the Cockcroft and Gault formula
- Adequate hepatic function (bilirubin ≤ 1.5 IULN, AST and 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]
Exclusion Criteria:
- Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other formulations
- History of significant cardiovascular disease or clinically significant ECG abnormality
- Patients with Gilbert's disease.
- Active infection requiring intravenous antibiotic use
- Patients 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 subjects who are candidates for curative intent therapy at the time of study enrollment
Studien-Rationale
Primary outcome:1. Progression-free survival (PFS) (Time Frame - within approximately 3 years):
PFS based on Investigator Assessment is defined as the time from randomization to the first clinical observation of disease progression or death.
2. Objective (overall) response rate (ORR) (Time Frame - within approximately 3 years):
ORR is defined as the percentage of participants who achieve objective CR or PR, confirmed by second assessment
Secondary outcome:
1. Overall Survival (OS) (Time Frame - within approximately 4 years):
OS is defined as the time from randomization to death
2. Duration of Response (DoR) (Time Frame - within approximately 3 years):
DoR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Studien-Arme
- Experimental: Sacituzumab Govitecan
Sacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle) - Active Comparator: TPC Comparator
TPC determined prior to randomization. Per NCCN guidelines (with dose modifications for if toxic) Eribulin; Capecitabine; Gemcitabine; Vinorelbine
Geprüfte Regime
- Sacituzumab Govitecan (IMMU-132):
Sacituzumab Govitecan (IMMU-132) is an antibody drug conjugate composed of the humanized monoclonal antibody, which binds to trophoblastic cell-surface antigen-2 (Trop-2); SN-38, a topoisomerase I inhibitor; and CL2A. - Eribulin (eribulin mesylate / Halaven / ):
Eribulin (per NCCN guidelines) - Capecitabine (Xeloda):
Capecitabine (per NCCN guidelines) - Gemcitabine (Gemzar):
Gemcitabine (per NCCN guidelines) - Vinorelbine (Navelbine):
Vinorelbine (per NCCN guidelines)
Quelle: ClinicalTrials.gov