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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

Immunomedics Medical Director
Study Director
Immunomedics, Inc.

Kontakt

Studienlocations (3 von 105)

HELIOS Klinikum Berlin-Buch
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Gynakologisches Zentrum Bonn
53111 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Brustzentrum Marienhospital Bottrop
Josef-Albers-Straße 70
46236 Bottrop
DeutschlandRekrutierend» Google-Maps
Städtisches Klinikum Dessau
06847 Dessau
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Hautkrebszentrum Universitätsklinikum Erlangen
Ulmenweg 18
91054 Erlangen
(Bayern)
DeutschlandRekrutierend» Google-Maps
Interdisziplinäres Brustkrebszentrum Kliniken Essen-Mitte
Henricistraße 92
45136 Essen
(Nordrhein-Westfalen)
DeutschlandRekrutierend» Google-Maps
Centrum für Hämatologie und Onkologie Bethanien
60389 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Onkologische Schwerpunktpraxis Eppendorf
20249 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Gynakologisch-Onkologische Praxis Hannover
30177 Hannover
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Nationales Centrum für Tumorerkrankungen - Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Praxisklinik für Hämatologie und Onkologie Koblenz
56068 Koblenz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Kopf-Hals-Tumorzentrum der Universitätsmedizin Mannheim
68167 Mannheim
DeutschlandRekrutierend» Google-Maps
HonorHealth Research Institute
85392 Avondale
United StatesAktiv, nicht rekrutierend» Google-Maps
Arizona Oncology Associates, PC
85704 Tucson
United StatesRekrutierend» Google-Maps
Highlands Oncology Group
72703 Fayetteville
United StatesRekrutierend» Google-Maps
University of California, San Diego Moores Cancer Center
92093 La Jolla
United StatesRekrutierend» Google-Maps
Los Angeles Hematology Oncology Medical Group
90017 Los Angeles
United StatesAktiv, nicht rekrutierend» Google-Maps
UCLA Department of Medicine - Hematology/Oncology
90095 Los Angeles
United StatesRekrutierend» Google-Maps
University of California, Irvine Medical Center-Chao Family Comprehensive Cancer Center
92868 Orange
United StatesRekrutierend» Google-Maps
Southern California Permanente Medical Group
92120 San Diego
United StatesRekrutierend» Google-Maps
UCSF Helen Diller Family Comprehensive Cancer Center
94115 San Francisco
United StatesRekrutierend» Google-Maps
Rocky Mountain Cancer Centers
80012 Aurora
United StatesRekrutierend» Google-Maps
Yale University Cancer Center
06520 New Haven
United StatesRekrutierend» Google-Maps
Georgetown University Medical Center
20007 Washington
United StatesRekrutierend» Google-Maps
University of Miami - Sylvester Comprehensive Cancer Center
33136 Miami
United StatesRekrutierend» Google-Maps
Moffitt Cancer Center
33612 Tampa
United StatesAktiv, nicht rekrutierend» Google-Maps
Emory University - Winship Cancer Institute
30322 Atlanta
United StatesRekrutierend» Google-Maps
Northside Hospital, Inc.
30342 Atlanta
United StatesRekrutierend» Google-Maps
University of Chicago Medical Center
60637 Chicago
United StatesRekrutierend» Google-Maps
The University of Kansas Cancer Center
66205 Westwood
United StatesRekrutierend» Google-Maps
James Graham Brown Cancer Center
40202 Louisville
United StatesRekrutierend» Google-Maps
Mercy Medical Center, Medical Oncology & Hematology
21202 Baltimore
United StatesRekrutierend» Google-Maps
Maryland Oncology Hematology, P.A.
20850 Rockville
United StatesRekrutierend» Google-Maps
Massachusetts General Hospital
02114 Boston
United StatesRekrutierend» Google-Maps
Beth Israel Deaconess Medical Center
02215 Boston
United StatesRekrutierend» Google-Maps
Dana Farber Cancer Institute
02215 Boston
United StatesRekrutierend» Google-Maps
Allina Health, Virginia Piper Cancer Institute
55407 Minneapolis
United StatesRekrutierend» Google-Maps
Masonic Cancer Center, University of Minnesota
55455 Minneapolis
United StatesRekrutierend» Google-Maps
Saint Luke's Cancer Institute
64111 Kansas City
United StatesRekrutierend» Google-Maps
Washington University School of Medicine - Siteman Cancer Center
63110 Saint Louis
United StatesRekrutierend» Google-Maps
St. Vincent Frontier Cancer Center
59102 Billings
United StatesRekrutierend» Google-Maps
Summit Medical Group
07932 Florham Park
United StatesRekrutierend» Google-Maps
Rutgers Cancer Institute of New Jersey
08903 New Brunswick
United StatesRekrutierend» Google-Maps
New York Oncology Hematology, P.C.
12206 Albany
United StatesRekrutierend» Google-Maps
Laura and Isaac Perlmutter Cancer Center/NYU Langone Health
10016 New York
United StatesRekrutierend» Google-Maps
Icahn School of Medicine at Mount Sinai
10029 New York
United StatesRekrutierend» Google-Maps
Columbia University Medical Center
10032 New York
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps
The Ohio State University
43210 Columbus
United StatesRekrutierend» Google-Maps
Thomas Jefferson University
19107 Philadelphia
United StatesRekrutierend» Google-Maps
Magee-Womens Hospital of UPMC
15213 Pittsburgh
United StatesRekrutierend» Google-Maps
The West Clinic, PC dba West Cancer Center
38138 Germantown
United StatesRekrutierend» Google-Maps
Tennessee Oncology, PLLC
37203 Nashville
United StatesRekrutierend» Google-Maps
Vanderbilt University Medical Center
37232 Nashville
United StatesRekrutierend» Google-Maps
Texas Oncology-Baylor Charles A. Sammons Cancer Center
75246 Dallas
United StatesRekrutierend» Google-Maps
University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
75390 Dallas
United StatesRekrutierend» Google-Maps
Texas Oncology-Denton South
76210 Denton
United StatesRekrutierend» Google-Maps
Houston Methodist Hospital/Houston Methodist Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Texas Oncology-Longview Cancer Center
75601 Longview
United StatesRekrutierend» Google-Maps
UT Health San Antonio - Mays Cancer Center
78229 San Antonio
United StatesRekrutierend» Google-Maps
Virginia Cancer Specialists
22205 Arlington
United StatesRekrutierend» Google-Maps
Virginia Oncology Associates
23502 Norfolk
United StatesRekrutierend» Google-Maps
Oncology & Hematology Associates of Southwest Virginia, Inc. DBA Blue Ridge Cancer Care
24153 Salem
United StatesRekrutierend» Google-Maps
Northwest Medical Specialties, PLLC
98405 Tacoma
United StatesRekrutierend» Google-Maps
Nova Scotia Cancer Centre
B3H 1V7 Halifax
CanadaAktiv, nicht rekrutierend» Google-Maps
Centre Georges-Francois Leclerc
21000 Dijon
FranceRekrutierend» Google-Maps
Institut Régional du Cancer de Montpellier
34298 Montpellier
FranceRekrutierend» Google-Maps
Hospices Civils de Lyon
69310 Pierre-Bénite
FranceRekrutierend» Google-Maps
Institut de Cancérologie Lucien Neuwirth
42271 Saint-Priest-en-Jarez
FranceRekrutierend» Google-Maps
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
29121 Piacenza
ItalyRekrutierend» Google-Maps
IFO Istituto Nazionale dei Tumori Regina Elena
00144 Rome
ItalyRekrutierend» Google-Maps
Antoni van Leeuwenhoekziekenhuis
1066 Amsterdam
NetherlandsRekrutierend» Google-Maps
Complejo Hospitalario Universitario A Coruna
15006 A Coruña
SpainRekrutierend» Google-Maps
Hospital Quirónsalud Barcelona Instituto Oncologico Baselga
08023 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital de la Santa Creu I Sant Pau
08041 Barcelona
SpainRekrutierend» Google-Maps
Hospital Provincial de Castellón
12002 Castillón
SpainRekrutierend» Google-Maps
Hospital Universitari Arnau de Vilanova
25198 Lleida
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Maranon
28007 Madrid
SpainRekrutierend» Google-Maps
Instituto Oncologico Bureau (IOB)
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Santiago de Compostela
15706 Santiago De Compostela
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio
41013 Sevilla
SpainRekrutierend» Google-Maps
Royal Cornwall Hospital NHS Trust
Cornwell
United KingdomRekrutierend» Google-Maps
Royal Surrey County Hospital
GU2 7XX Guildford
United KingdomAktiv, nicht rekrutierend» Google-Maps
Leicester Royal Infirmary
LE1 5WW Leicester
United KingdomRekrutierend» Google-Maps
Barts Health NHS Trust
EC1A 7BE London
United KingdomRekrutierend» Google-Maps
The Royal Marsden NHS Foundation Trust
SW3 6JJ London
United KingdomRekrutierend» Google-Maps
The Christie NHS Foundation Trust
Manchester
United KingdomRekrutierend» Google-Maps
Alle anzeigen

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


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