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Fachinformation
JOURNAL ONKOLOGIE – STUDIE

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

Rekrutierend

NCT-Nummer:
NCT03975647

Studienbeginn:
Oktober 2019

Letztes Update:
29.07.2021

Wirkstoff:
Tucatinib, Placebo, T-DM1

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Seagen Inc.

Collaborator:
-

Studienleiter

Evelyn Rustia, MD
Study Director
Seagen Inc.

Kontakt

Studienlocations
(3 von 221)

Helios Klinikum Berlin-Buch
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Kliniken Essen-Mitte - Evang. Huyssens-Stiftung
45136 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Hamburg-Eppendorf (UKE)
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Schleswig-Holstein
24105 Kiel
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
InVO- Institut fUr Versorgungsforschung in der onkologie GbR
56068 Koblenz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
55101 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Sana Klinikum Offenbach GmbH
63069 Offenbach am Main
(Hessen)
GermanyRekrutierend» Google-Maps
University of South Alabama - Mitchell Cancer Institute
36604 Mobile
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Pam Francisco
Phone: 251-445-9870
E-Mail: pfrancisco@health.southalabama.edu» Ansprechpartner anzeigen
Cancer Treatment Centers of America / Western Regional Medical Center
85338 Goodyear
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jessica Coats
Phone: 623-207-3126
E-Mail: jessica.coats@ctca-hope.com» Ansprechpartner anzeigen
California Cancer Associates for Research and Excellence Inc (cCARE)
92024 Encinitas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Juan Morales
Phone: 760-747-8935
E-Mail: jmorales2@ccare.com» Ansprechpartner anzeigen
Chao Family Comprehensive Cancer Center University of California Irvine
92868 Orange
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Pamela Diaz
Phone: 714-456-8614
E-Mail: Pamelad1@uci.edu» Ansprechpartner anzeigen
UCLA Medical Center / David Geffen School of Medicine
90404 Santa Monica
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Monica Rocha
Phone: 310-582-6324
E-Mail: mprocha@mednet.ucla.edu» Ansprechpartner anzeigen
Kaiser Permanente Medical Center Northern California
94589 Vallejo
United StatesRekrutierend» Google-Maps
University of Colorado Hospital / University of Colorado
80045-0510 Aurora
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Leah Adams
Phone: 720-848-7341
E-Mail: leah.adams@cuanschutz.edu» Ansprechpartner anzeigen
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
80021 Broomfield
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Nicole Steiner
Phone: 303-318-3434
E-Mail: nicole.steiner@sclhealth.org» Ansprechpartner anzeigen
University of Colorado Health Memorial Hospital
80909 Colorado Springs
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Autumn Clemons
Phone: 719-365-5746
E-Mail: autumn.clemons@uchealth.org» Ansprechpartner anzeigen
Helen F. Graham Cancer Center / Christiana Care Health Systems
19713 Newark
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Elizabeth MacWade
Phone: 302-623-4500
E-Mail: elizabeth.macwade@usoncology.com» Ansprechpartner anzeigen
Lombardi Cancer Center / Georgetown University Medical Center
20007 Washington
United StatesRekrutierend» Google-Maps
H. Lee Moffitt Cancer Center and Research Institute
33612 Tampa
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists - East West Palm Beach, FL (SCRI)
33401 West Palm Beach
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jenifer Bar-Nur
Phone: 561-472-1696
E-Mail: jbar-nur@flcancer.com» Ansprechpartner anzeigen
Winship Cancer Institute / Emory University School of Medicine
30322 Atlanta
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Vanessa Falero
Phone: 404-778-1900
E-Mail: vanessa.falero@emoryhealthcare.org» Ansprechpartner anzeigen
Kapi'olani Medical Center for Women and Children
96826 Honolulu
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Emelie Chang
Phone: 808-983-8749
E-Mail: emelie.chang@hawaiipacifichealth.org» Ansprechpartner anzeigen
Illinois Cancer Specialists - Arlington Heights
60005 Arlington Heights
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Heather Lee
Phone: 847-259-4482
E-Mail: heather.lee@usoncology.com» Ansprechpartner anzeigen
Beth Israel Deaconess Medical Center
02215 Boston
United StatesRekrutierend» Google-Maps
North Mississippi Medical Center Hematology Oncology - Tupelo
38801 Tupelo
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jeff Michelletti
Phone: 662-377-4550
E-Mail: jnmichelletti@nmhs.net» Ansprechpartner anzeigen
New York Oncology Hematology, P.C.
12206 Albany
United StatesRekrutierend» Google-Maps
Stony Brook University Cancer Center
11794-7263 Stony Brook
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Pushpa Talanki
Phone: 631-638-0815
E-Mail: pushpa.talanki@stonybrookmedicine.edu» Ansprechpartner anzeigen
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
27599 Chapel Hill
United StatesRekrutierend» Google-Maps
University of Pennsylvania / Perelman Center for Advanced Medicine
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Cancer Treatment Centers of America / Eastern Regional Medical Center
19124 Philadelphia
United StatesAbgeschlossen» Google-Maps
Brig Center for Cancer Care and Survivorship
37909 Knoxville
United StatesAbgeschlossen» Google-Maps
Texas Oncology - Bedford
76022 Bedford
United StatesRekrutierend» Google-Maps
Texas Oncology - Baylor Sammons Cancer Center
75246 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jonathan Huntzinger
Phone: 214-370-1000
E-Mail: jonathan.huntzinger@usoncology.com» Ansprechpartner anzeigen
University of Texas Southwestern Medical Center
75390 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jessica Medina
Phone: 214-648-7041
E-Mail: Jessica.Medina2@utsouthwestern.edu» Ansprechpartner anzeigen
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
24153 Salem
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Natasha R Holt
Phone: 540-774-8660
E-Mail: natasha.holt@usoncology.com» Ansprechpartner anzeigen
Medizinische Universitat Innsbruck
6020 Innsbruck
AustriaRekrutierend» Google-Maps
LKH Salzburg, Universitatsklinikum der PMU
5020 Salzburg
AustriaRekrutierend» Google-Maps
Cliniques Universitaires Saint Luc
1200 Brussels
BelgiumRekrutierend» Google-Maps
Grand Hôpital de Charleroi - Saint-Joseph
6000 Charleroi
BelgiumRekrutierend» Google-Maps
Universitair Ziekenhuis Antwerpen
2650 Edegem
BelgiumRekrutierend» Google-Maps
Academisch Ziekenhuis Groeninge
8500 Kortrijk
BelgiumRekrutierend» Google-Maps
Universitair Ziekenhuis Leuven
3000 Lueven
BelgiumRekrutierend» Google-Maps
CHU UCL Namur-Site de Saint Elisabeth
5000 Namur
BelgiumRekrutierend» Google-Maps
University of Alberta / Cross Cancer Institute
T6G 1Z2 Edmonton
CanadaRekrutierend» Google-Maps
Queen Elizabeth II Health Sciences Centre
B3H 2Y9 Halifax
CanadaRekrutierend» Google-Maps
Cancer Centre of Southeastern Ontario At Kingston General Hospital
K7L 5P9 Kingston
CanadaRekrutierend» Google-Maps
London Health Sciences Centre - Victoria Hospital
N6A 5W9 London
CanadaRekrutierend» Google-Maps
University of Ottawa / Ottawa General Hospital
K1H 8L6 Ottawa
CanadaRekrutierend» Google-Maps
University Health Network, Princess Margaret Hospital
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
H2X 0A9 Montreal
CanadaRekrutierend» Google-Maps
Hopital du Saint-Sacrement, CHU de Quebec-Universite Laval
G1S 4L8 Quebec
CanadaRekrutierend» Google-Maps
Ansprechpartner:
Seattle Genetics Trial Information Support
Phone: 866-333-7426
E-Mail: clinicaltrials@seagen.com» Ansprechpartner anzeigen
Sygehus Lillebaelt - Vejle Sygehus
7100 Vejle
DenmarkRekrutierend» Google-Maps
University Hospital of Besancon
25030 Besancon cedex
FranceRekrutierend» Google-Maps
Hospital Center Regional University Morvan De Brest
29200 Brest
FranceRekrutierend» Google-Maps
Centre de Lutte contre le Cancer - François Baclesse
14076 Caen Cedex 5
FranceRekrutierend» Google-Maps
Center Georges Francois Leclerc
21000 Dijon
FranceRekrutierend» Google-Maps
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
69373 Lyon
FranceRekrutierend» Google-Maps
Institute Curie - Centre de Lutte Contre Le Cancer CLCC de Paris
75298 CEDEX 05 Paris
FranceRekrutierend» Google-Maps
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
76038 Rouen
FranceRekrutierend» Google-Maps
Hopitaux Universitaires de Strasbourg
67200 Strasbourg
FranceRekrutierend» Google-Maps
Institut Claudius Regaud IUCT-O
31059 Toulouse Cedex 9
FranceRekrutierend» Google-Maps
CHU Tours - Hopital Bretonneau
37044 TOURS Cedex 09
FranceRekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
40138 Bologna
ItalyRekrutierend» Google-Maps
Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo FPO - IRCCS
10060 Candiolo
ItalyRekrutierend» Google-Maps
Seconda Università degli Studi di Napoli, AOU
80131 Napoli
ItalyRekrutierend» Google-Maps
Policlinico Universitario Agostino Gemelli
00168 Roma
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera S. Maria di Terni
05100 Terni
ItalyRekrutierend» Google-Maps
A.O.U. - Ospedali Riuniti di Ancona
60126 Torrette
ItalyRekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Seagen Trial Information Support
Phone: 866-333-7436
E-Mail: clinicaltrials@seagen.com» Ansprechpartner anzeigen
Erasmus Medisch Centrum Daniel Den Hoed
3075 EA Rotterdam
NetherlandsRekrutierend» Google-Maps
Hospital Universitario Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Reina Sofia
14004 Cordoba
SpainRekrutierend» Google-Maps
Hospital Universitario de Canarias
38320 La Cuesta
SpainRekrutierend» Google-Maps
Hospital Universitario HM Sanchinarro
28050 Madrid
SpainRekrutierend» Google-Maps
Hospital Son Espases
07120 Palma de Mallorca
SpainRekrutierend» Google-Maps
Institut Catala D'Oncologia Hospitalet
08970 Saint Joan Despi
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio
41013 Sevilla
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia
46010 Valencia
SpainRekrutierend» Google-Maps
Hospital Universitario Miguel Servet
50009 Zaragoza
SpainRekrutierend» Google-Maps
University Hospital Basel - Brustzentrum
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Institute of Oncology of Southern Switzerland
6500 Bellinzona
SwitzerlandRekrutierend» Google-Maps
University Hospital Lausanne CHUV
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Kantonsspital Winterthur (KSW)
8401 Winterthur
SwitzerlandRekrutierend» Google-Maps
Addenbrooke's Hospital
CB2 0QQ Cambridge
United KingdomRekrutierend» Google-Maps
The University of Edinburgh
EH4 2XU Edinburgh
United KingdomRekrutierend» Google-Maps
Oxford University Hospitals
OX3 7LE Headington
United KingdomRekrutierend» Google-Maps
The Royal Marsden NHS Foundation Trust (RM)
SW3 6JJ London
United KingdomRekrutierend» Google-Maps
Sarah Cannon Research Institute UK
W1G 6AD London
United KingdomRekrutierend» Google-Maps
Maidstone and Tunbridge Wells NHS Trust
ME16 9QQ Maidstone
United KingdomRekrutierend» Google-Maps
The Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomRekrutierend» Google-Maps
The Newcastle upon Tyne Hospitals NHS Foundation Trust
NE7 7DN Newcastle Upon Tyne
United KingdomRekrutierend» Google-Maps
Mount Vernon Hospital, UK
HA6 2RN Northwood
United KingdomRekrutierend» Google-Maps
The Royal Marsden Hospital (Surrey)
SM2 5PT Sutton
United KingdomRekrutierend» Google-Maps
Royal Cornwall Hospitals NHS Trust
TR1 3LQ Truro
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This study is designed to evaluate the efficacy and safety of tucatinib in combination with

T-DM1 in subjects with unresectable locally-advanced or metastatic HER2+ breast cancer who

have had prior treatment with a taxane and trastuzumab in any setting. Prior pertuzumab

treatment is permitted, but not required. Subjects will be randomized in a 1:1 manner to

receive 21-day cycles of either tucatinib or placebo in combination with T-DM1.

While on study treatment, subjects will be assessed for progression every 6 weeks for the

first 24 weeks, and every 9 weeks thereafter, irrespective of dose holds or interruptions.

Study treatment will continue until unacceptable toxicity, disease progression, withdrawal of

consent, or study closure. After completion of study treatment and after occurrence of

disease progression, subjects in both arms of the study will continue to be followed for

survival until study closure or withdrawal of consent.

Ein-/Ausschlusskriterien

- Inclusion Criteria:

- Histologically confirmed HER2+ breast carcinoma as determined by a

sponsor-designated central laboratory

- History of prior treatment with a taxane and trastuzumab in any setting,

separately or in combination

- Have progression of unresectable locally advanced/metastatic breast cancer after

last systemic therapy, or be intolerant of last systemic therapy

- Measurable or non-measurable disease assessable by RECIST v1.1

- ECOG performance status score of 0 or 1

- CNS Inclusion - Based on screening contrast brain magnetic resonance imaging

(MRI), subjects must have at least one of the following:

(a) No evidence of brain metastases

(b) Untreated brain metastases not needing immediate local therapy

(c) Previously treated brain metastases

1. Brain metastases previously treated with local therapy may either be stable

since treatment or may have progressed since prior local CNS therapy,

provided that there is no clinical indication for immediate re-treatment

with local therapy

2. Subjects treated with CNS local therapy for newly identified lesions or

previously treated and progressing lesions may be eligible to enroll if all

of the following criteria are met:

(i) Time since SRS is at least 7 days prior to first dose of study

treatment, time since WBRT is at least 21 days prior to first dose, or time

since surgical resection is at least 28 days.

(ii) Other sites of evaluable disease are present

3. Relevant records of any CNS treatment must be available to allow for

classification of target and non-target lesions

- Exclusion Criteria:

- Prior treatment with tucatinib, afatinib, trastuzumab deruxtecan (DS-8201a), or

any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent. Prior

treatment with lapatinib or neratinib within 12 months of starting study

treatment (except in cases where they were given for ≤21 days and was

discontinued for reasons other than disease progression or severe toxicity).

Prior treatment with pyrotinib for recurrent of mBC (except in cases where

pyrotinib was given for ≤21 days and was discontinued for reasons other than

disease progression or severe toxicity).

- CNS Exclusion - Based on screening contrast brain magnetic resonance imaging

(MRI), subjects must not have any of the following:

1. Any untreated brain lesions >2 cm in size

2. Ongoing use of corticosteroids for control of symptoms of brain metastases

at a total daily dose of >2 mg of dexamethasone (or equivalent).

3. Any brain lesion thought to require immediate local therapy

4. Known or concurrent leptomeningeal disease as documented by the investigator

5. Poorly controlled generalized or complex partial seizures

Studien-Rationale

Primary outcome:

1. Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator assessment (Time Frame - Up to approximately 5 years):
PFS per investigator is defined as the time from the date of randomization to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.



Secondary outcome:

1. Overall Survival (Time Frame - Up to approximately 5 years):
OS is defined as the time from randomization to death due to any cause.

2. PFS per RECIST v1.1 by blinded independent committee review (BICR) (Time Frame - Up to approximately 5 years):
PFS per BICR is defined as the time from the date of randomization to the centrally-reviewed documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.

3. PFS per RECIST v1.1 by investigator assessment in participants with brain metastases at baseline (Time Frame - Up to approximately 5 years)

4. PFS per RECIST v1.1 by BICR in patients with brain metastases at baseline (Time Frame - Up to approximately 5 years)

5. Objective response rate (ORR) per RECIST v1.1 by investigator assessment (Time Frame - Up to approximately 3 years):
ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST v1.1.

6. ORR per RECIST v1.1 by BICR (Time Frame - Up to approximately 3 years)

7. Duration of response (DOR) per RECIST v1.1 by investigator assessment (Time Frame - Up to approximately 5 years):
DOR is defined as the time from first documentation of objective response to the first documentation of disease progression or death from any cause, whichever occurs earlier.

8. DOR per RECIST v1.1 by BICR (Time Frame - Up to approximately 5 years)

9. Clinical benefit rate (CBR) per RECIST v1.1 by investigator assessment (Time Frame - Up to approximately 3 years):
CBR is defined as the proportion of subjects with stable disease (SD) or non-CR or non-PD for ≥6 months or best response of CR or PR according to RECIST v1.1.

10. CBR per RECIST v1.1 by BICR (Time Frame - Up to approximately 3 years)

11. Number of participants with adverse events (AEs) (Time Frame - Through 1 month following last dose; up to approximately 9 months overall per participant):
An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Studien-Arme

  • Experimental: Tucatinib + T-DM1
    Tucatinib + T-DM1
  • Active Comparator: Placebo + T-DM1
    Placebo + T-DM1

Geprüfte Regime

  • tucatinib (ONT-380):
    300mg given twice per day by mouth (orally)
  • placebo:
    Given twice per day orally
  • T-DM1 (Kadcyla):
    3.6 mg/kg given into the vein (IV; intravenously) every 21 days

Quelle: ClinicalTrials.gov


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