Clinical trial • Phase III • Oncology

TRASTUZUMAB DERUXTECAN for HER2-positive metastatic breast cancer | Advanced breast cancer

Phase III trial of TRASTUZUMAB DERUXTECAN for HER2-positive metastatic breast cancer | Advanced breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
HER2-positive metastatic breast cancer | Advanced breast cancer
Trial Stage
Phase III
Drug Modality
ADC | Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
15-04-2024
First CTIS Authorization Date
16-05-2024

Trial design

Randomised, standard of care (taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)-controlled Phase III trial in Denmark, Sweden, Germany and others.

Randomised
Yes
Comparator
Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)
Target Sample Size
991

Eligibility

Recruits 991 Vulnerable population selected (isVulnerablePopulationSelected = true). The record does not provide further details on consent/assent handling for vulnerable participants in the extract provided..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). The record does not provide further details on consent/assent handling for vulnerable participants in the extract provided.

Inclusion criteria

  • {"criterion_text":"- Patients must be ≥18 years of age\n- Pathologically documented breast cancer that: 1. is advanced or metastatic 2. is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+) 3. is documented by local testing as hormone receptor (HR)-positive or HR-negative disease in the metastatic setting\n- No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer or only 1 previous line of endocrine therapy in the metastatic setting. Participants who have received chemotherapy or HER2-targeted therapy in the neo-adjuvant or adjuvant setting are eligible if > 6 months from treatment to metastatic diagnosis.\n- Has protocol-defined adequate organ and bone marrow function\n- ECOG performance status 0 or 1"}

Exclusion criteria

  • {"criterion_text":"- Ineligible for any of the agents on the study.\n- Any substance abuse or other medical conditions that, in the investigator's opinion, may interfere with subject's participation or study results\n- Patients with spinal cord compression or clinically active central nervous system metastases. Participants with clinically inactive brain metastases or treated brain metastases that are no longer symptomatic may be included in the study.\n- Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening\n- Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS is defined as the time from date of randomisation until the date of objective radiological disease progression according to BICR using RECIST 1.1 or death by any cause.","definition_or_measurement_approach":"Time from date of randomisation until date of objective radiological disease progression according to BICR using RECIST 1.1 or death by any cause."}

Secondary endpoints

  • {"endpoint_text":"- PFS is defined as the time from date of randomisation until the date of objective radiological disease progression according to investigator assessment using RECIST 1.1 or death by any cause.","definition_or_measurement_approach":"Time from date of randomisation until date of objective radiological disease progression according to investigator assessment using RECIST 1.1 or death by any cause."}
  • {"endpoint_text":"- OS is defined as the time from randomisation until the date of death due to any cause.","definition_or_measurement_approach":"Time from randomisation until date of death due to any cause."}
  • {"endpoint_text":"- ORR is defined as the proportion of participants who have a CR or PR, as determined by BICR and investigator assessment per RECIST 1.1. DoR is defined as the time from date of first detection of objective response until the date of objective radiological disease progression according to BICR and investigator assessment using RECIST 1.1 or death in the absence of progression.","definition_or_measurement_approach":"ORR: proportion of participants with CR or PR per RECIST 1.1 by BICR and investigator assessment. DoR: time from first detection of objective response until objective radiological disease progression by BICR and investigator assessment using RECIST 1.1 or death in absence of progression."}
  • {"endpoint_text":"- Time to second progression or death (PFS2) by Investigator assessment","definition_or_measurement_approach":"Time to second progression or death (PFS2) as assessed by investigator."}
  • {"endpoint_text":"- Health related quality of life (HRQoL) using the European Organisation for Research and Treatment of Cancer (EORTC)","definition_or_measurement_approach":"HRQoL measured using EORTC instruments."}
  • {"endpoint_text":"- Serum concentration of trastuzumab deruxtecan and pertuzumab","definition_or_measurement_approach":"Pharmacokinetic measurement of serum concentrations of trastuzumab deruxtecan and pertuzumab."}
  • {"endpoint_text":"- Immunogenicity of trastuzumab deruxtecan, alone or with pertuzumab.","definition_or_measurement_approach":"Assessment of immunogenicity (anti-drug antibodies) of trastuzumab deruxtecan alone or in combination with pertuzumab."}
  • {"endpoint_text":"- Safety and tolerability of trastuzumab deruxtecan, alone or with pertuzumab","definition_or_measurement_approach":"Safety and tolerability assessments (adverse events, lab parameters, etc.) for trastuzumab deruxtecan alone or with pertuzumab."}

Recruitment

Planned Sample Size
991
Recruitment Window Months
104
Consent Approach
Informed consent is required from participants who must be ≥18 years of age. Subject information and informed consent forms are available in multiple languages (documents listed for English, German, French, Spanish, Italian, Hungarian, Romanian, Dutch, Swedish among others). No details on assent were provided in the extracted record.

Geography

Total Number Of Sites
62
Total Number Of Participants
143

Denmark

Latest Decision Or Authorization Date
16-05-2024
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Lillebaelt Hospital
Department Name
Clinical research unit, oncological department
Contact Person Name
Else Iversen
Contact Person Email
else.iversen@rsyd.dk
Site Name
Rigshospitalet
Department Name
Oncological clinic 5073, Finsencenteret
Contact Person Name
Ann Knop
Contact Person Email
ann.soeegaard.knop@regionh.dk

Sweden

Latest Decision Or Authorization Date
21-05-2024
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Soedersjukhuset AB
Department Name
Onkologiska Kliniken, Kliniska Forskningsenheten
Contact Person Name
Sara Margolin
Contact Person Email
sara.margolin@sll.se
Site Name
Region Kronoberg
Department Name
Onkologikliniken
Contact Person Name
Emma Samuelsson Gustbée
Contact Person Email
emma.gustbee@kronoberg.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
VO Onkologi
Contact Person Name
Leif Klint
Contact Person Email
Leif.klint@vgregion.se

Germany

Latest Decision Or Authorization Date
22-05-2024
Number Of Sites
10
Number Of Participants
16

Sites

Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
Klinik für Gynäkologie und Gynäkologische Onkologie
Contact Person Name
Marc Thill
Contact Person Email
marc.thill@agaplesion.de
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Senologie
Contact Person Name
Sherko Kuemmel
Contact Person Email
s.kuemmel@kem-med.com
Site Name
National Center For Tumor Diseases (NCT) Heidelberg
Department Name
Gynäkologische Onkologie Zentrum für gynäkologische Krebserkrankungen
Contact Person Name
Andreas Schneeweiß
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Frauenklinik
Contact Person Name
Peter Fasching
Site Name
Mammazentrum Hamburg MVZ GbR
Department Name
Operative Therapie und Onkologie
Contact Person Name
Christian Schem
Contact Person Email
schem@mammazentrum.eu
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Frauenheilkunde
Contact Person Name
Bahriye Aktas
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Pauline Wimberger
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Campus Charité Mitte Klinik für Gynäkologie mit Brustzentrum
Contact Person Name
Verena Kiver
Contact Person Email
verena.kiver@charite.de
Site Name
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
Department Name
Senologie
Contact Person Name
Matthias Schem
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Studienzentrale Senologie Ebene 05 West
Contact Person Name
Joke Tio
Contact Person Email
joke.tio@ukmuenster.de

Belgium

Latest Decision Or Authorization Date
03-06-2024
Number Of Sites
7
Number Of Participants
13

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Contact Person Name
François Duhoux
Contact Person Email
francois.duhoux@uclouvain.be
Site Name
UZ Leuven
Department Name
Algemene Medische Oncologie (AMO)
Contact Person Name
Hans Wildiers
Contact Person Email
hans.wildiers@uzleuven.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Hôpital de jour oncologie C3
Contact Person Name
Donatienne Taylor
Site Name
Antwerp University Hospital
Department Name
Gynaeco-Oncology
Contact Person Name
Konstantinos Papadimitriou
Site Name
Grand Hopital De Charleroi
Department Name
Oncology-Hematology unit
Contact Person Name
Jean-Luc Canon
Contact Person Email
Jean-Luc.Canon@ghdc.be
Site Name
Az Maria Middelares Gent
Department Name
Medical Oncology
Contact Person Name
Félix Gremonprez
Site Name
Chirec
Department Name
Medical Oncology
Contact Person Name
Thierry Velu
Contact Person Email
thierry.velu@oncolife.be

Spain

Latest Decision Or Authorization Date
04-06-2024
Number Of Sites
8
Number Of Participants
29

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Cristina Saura Manich
Contact Person Email
csaura@vhio.net
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
Luis De la Cruz Merino
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Maria Jesus Vidal Losada
Contact Person Email
mjvidal@clinic.cat
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology
Contact Person Name
Javier Cortes Castan
Contact Person Email
jacortes@vhio.net
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Contact Person Name
Pilar Zamora Aunon
Contact Person Email
zamorapilar@gmail.com
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Oncology
Contact Person Name
Jose Ponce Lorenzo
Contact Person Email
joseponcelorenzo@hotmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Eva Maria Ciruelos Gil
Contact Person Email
eva.ciruelos@gmail.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Contact Person Name
Ricardo Cubedo Cervez
Contact Person Email
rcubedo@gmail.com

Romania

Latest Decision Or Authorization Date
24-05-2024
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Departament Oncologie Medicala
Contact Person Name
Andrei Ungureanu
Site Name
Elias University Emergency Hospital
Department Name
Sectia Oncologie Medicala
Contact Person Name
Cristian Ioan Iaciu
Contact Person Email
iaciu.cristian@yahoo.com

Hungary

Latest Decision Or Authorization Date
03-06-2024
Number Of Sites
9
Number Of Participants
16

Sites

Site Name
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz
Department Name
Klinikai Onkológia Osztály
Contact Person Name
Zsuzsanna Nagy
Contact Person Email
onkologia@szentimrekorhaz.hu
Site Name
Budapesti Uzsoki Utcai Korhaz
Department Name
Onkoradiológiai Osztály
Contact Person Name
Edina Mészáros
Contact Person Email
m.edina@uzsoki.hu
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Osztály
Contact Person Name
Wéber Ágnes
Contact Person Email
agneswebermd@gmail.com
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Onkoradiológiai Osztály
Contact Person Name
András Szigeti
Contact Person Email
drszigetia.petz@gmail.com
Site Name
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Department Name
Onkológiai Osztály
Contact Person Name
Hajnalka Németh
Contact Person Email
nemethhajnalka@hotmail.com
Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
Onkológiai Osztály
Contact Person Name
Zsuzsanna Pápai
Contact Person Email
trial.zspapai@gmail.com
Site Name
Semmelweis Egyetem
Department Name
Belgyógyászati és Onkológiai Klinika
Contact Person Name
Gyöngyvér Szentmártoni
Contact Person Email
gyszentmartoni@gmail.com
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Contact Person Name
Zsolt Horváth
Contact Person Email
horvathzso.study@kmk.hu
Site Name
Orszagos Onkologiai Intezet
Department Name
Mellkasi és Hasüregi Daganatok és Klinikai Farmakológiai Osztály "Kemoterápia B"
Contact Person Name
Balázs Madaras
Contact Person Email
studymadaras@gmail.com

France

Latest Decision Or Authorization Date
22-05-2024
Number Of Sites
16
Number Of Participants
37

Sites

Site Name
Centre Antoine Lacassagne
Department Name
Breast Oncology
Contact Person Name
Jean-Marc Ferrero
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Breast Oncology
Contact Person Name
William Jacot
Contact Person Email
William.Jacot@icm.unicancer.fr
Site Name
Clinique Tivoli Ducos
Department Name
Breast Oncology
Contact Person Name
Delphine Garbay
Contact Person Email
d.garbay@tivoli-oncologie.fr
Site Name
Centre Hospitalier Lyon Sud
Department Name
Breast Oncology
Contact Person Name
Nathalie Bonnin
Contact Person Email
nathalie.bonnin@chu-lyon.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Breast Oncology
Contact Person Name
Marie Rober
Contact Person Email
Marie.Robert@ico.unicancer.fr
Site Name
Clinique Victor Hugo
Department Name
Breast Oncology
Contact Person Name
Sophie Roche
Contact Person Email
s.roche@ilcgroupe.fr
Site Name
Institut Sainte Catherine
Department Name
Breast Oncology
Contact Person Name
Julien Grenier
Contact Person Email
j.grenier@isc84.org
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Breast Oncology
Contact Person Name
Mony Ung
Contact Person Email
ung.mony@iuct-oncopole.fr
Site Name
Centre Francois Baclesse
Department Name
Breast Oncology
Contact Person Name
Christelle Levy
Contact Person Email
C.LEVY@baclesse.unicancer.fr
Site Name
Institut Curie (Paris)
Department Name
Breast Oncology
Contact Person Name
Jean-Yves Pierga
Contact Person Email
jean-yves.pierga@curie.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Breast Oncology
Contact Person Name
Veronique Dieras
Contact Person Email
v.dieras@rennes.unicancer.fr
Site Name
Institut De Cancerologie De Lorraine
Department Name
Breast Oncology
Contact Person Name
Vincent Massard
Contact Person Email
v.massard@nancy.unicancer.fr
Site Name
Centre De Cancerologue Du Grand Montpellier
Department Name
Breast Oncology
Contact Person Name
Cristian Villanueva
Contact Person Email
villanueva@ccgm.fr
Site Name
Hospital Saint Jacques
Department Name
Medical oncology
Contact Person Name
Laura MANSI
Contact Person Email
lmansi@chu-besancon.fr
Site Name
Institut Curie (Saint-Cloud)
Department Name
Breast Oncology
Contact Person Name
Etienne Brain
Contact Person Email
etienne.brain@curie.fr
Site Name
Centre Hospitalier Lyon Sud (duplicate listing omitted if present)

Italy

Latest Decision Or Authorization Date
29-05-2024
Number Of Sites
5
Number Of Participants
22

Sites

Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Department Name
Oncology
Contact Person Name
Elena Rota Caremoli
Contact Person Email
ecrota@asst-pg23.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncology
Contact Person Name
Marco Angelo Colleoni
Contact Person Email
marco.colleoni@ieo.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. Oncology and Ematology
Contact Person Name
Giuseppe Saltalamacchia
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
SSD Breast Unit
Contact Person Name
Lucia Del Mastro
Contact Person Email
lucia.delmastro@hsanmartino.it
Site Name
Istituto Oncologico Veneto
Department Name
Oncology
Contact Person Name
Valentina Guarnieri

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Contract research organisations

Name
PPD Development LP
Responsibilities
4
Name
IQVIA Limited
Responsibilities
6
Name
Parexel International Limited
Responsibilities
Medical image analysis/ review - X-ray, MRI, ultrasound, etc.
Name
Signant Health Global LLC
Responsibilities
3
Name
RWS Life Sciences Inc.
Responsibilities
ePRO questionnaire translations
Name
Discovery Life Sciences LLC
Responsibilities
Diagnostic Tissue Testing
Name
ERT (Clario)
Responsibilities
electronic patient-reported outcome

Third parties

  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"ePRO questionnaire translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"Diagnostic Tissue Testing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Parexel International Limited","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"ERT (Clario)","duties_or_roles":"electronic patient-reported outcome","organisation_type":"Industry"}

Investigational products

Investigational Product Name
DS-8201a
Active Substance
TRASTUZUMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
prodAuthStatus=1
Investigational Product Name
PERTUZUMAB
Active Substance
PERTUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
prodAuthStatus=2
Investigational Product Name
TRASTUZUMAB
Active Substance
TRASTUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
prodAuthStatus=2
Investigational Product Name
PACLITAXEL
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
prodAuthStatus=2
Investigational Product Name
DOCETAXEL
Active Substance
DOCETAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
prodAuthStatus=2
Investigational Product Name
Placebo (Saline 0.9% (weight per volume; w/v)) for Pertuzumab
Modality
Other
Combination Treatment
Yes

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