Clinical trial • Phase III • Oncology

GIREDESTRANT for Estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer

Phase III trial of GIREDESTRANT for Estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
21-02-2024
First CTIS Authorization Date
27-03-2024

Trial design

Randomised, letrozole (femara® 2.5 mg film-coated tablets) combined with palbociclib (ibrance; palbociclib formulations 75 mg/100 mg/125 mg oral formulations). specific daily maximum doses in the registry: letrozole up to 2.5 mg daily; palbociclib reported max daily dose 125 mg. detailed schedule (dosing schedule/treatment cycle length) is not specified in the json.-controlled Phase III trial in Portugal, Belgium, Poland and others.

Randomised
Yes
Comparator
Letrozole (Femara® 2.5 mg film-coated tablets) combined with palbociclib (IBRANCE; palbociclib formulations 75 mg/100 mg/125 mg oral formulations). Specific daily maximum doses in the registry: letrozole up to 2.5 mg daily; palbociclib reported max daily dose 125 mg. Detailed schedule (dosing schedule/treatment cycle length) is not specified in the JSON.
Target Sample Size
982

Eligibility

Recruits 982 Vulnerable population selected. Informed consent is obtained using subject information and informed consent forms (multiple ICF documents are provided in multiple languages). Specific assent or legal representative procedures are not detailed in the provided JSON..

Pregnancy Exclusion
Pregnant or breastfeeding
Vulnerable Population
Vulnerable population selected. Informed consent is obtained using subject information and informed consent forms (multiple ICF documents are provided in multiple languages). Specific assent or legal representative procedures are not detailed in the provided JSON.

Inclusion criteria

  • {"criterion_text":"- For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment\n- Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent\n- Documented ER-positive tumor and HER2-negative tumor, assessed locally\n- No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease\n- Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months\n- Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed\n- Eastern Cooperative Oncology Group Performance Status 0-1"}

Exclusion criteria

  • {"criterion_text":"- Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor\n- Prior treatment with a selective estrogen receptor degrader\n- Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization\n- Advanced, symptomatic, visceral spread that is at risk of lifethreatening complications in the short term\n- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease\n- Active cardiac disease or history of cardiac dysfunction\n- Pregnant or breastfeeding"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Progression-free survival (PFS","definition_or_measurement_approach":"Primary objective: To evaluate efficacy on the basis of progression-free survival (PFS). Measurable disease is defined per RECIST v1.1 (see inclusion criteria). No further measurement approach detail is provided in the JSON."}

Secondary endpoints

  • {"endpoint_text":"- 1. Overall survival (OS)\n- 2. Objective response rate (ORR)\n- 3. Duration of response (DOR)\n- 4. Clinical benefit rate (CBR)\n- 5. Time to confirmed deterioration (TTCD) in pain level\n- 6. TTCD in pain presence and interference\n- 7. TTCD in physical functioning (PF)\n- 8. TTCD in role functioning (RF)\n- 9. TTCD in global health status (GHS) and quality-of-life (QoL)\n- 10. Incidence and severity of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0)\n- 11. Change from baseline in targeted vital signs\n- 12. Plasma concentration of GDC-9545 at specified timepoints\n- 13. Plasma concentration of palbociclib at specified timepoints","definition_or_measurement_approach":"OS, ORR, DOR, CBR and related efficacy endpoints: measurement approach not specified in JSON; measurable disease is defined per RECIST v1.1 (in inclusion criteria). Safety: incidence and severity of adverse events determined according to NCI CTCAE v5.0. PK endpoints: plasma concentration at specified timepoints (timepoints not listed in JSON). Quality-of-life and TTCD endpoints: no detailed instruments or schedules specified in JSON."}

Recruitment

Planned Sample Size
982
Recruitment Window Months
74
Consent Approach
Informed consent is obtained using subject information and informed consent forms. Multiple ICF documents are listed in the dossier including main ICFs and optional/addendum forms; translations and country-specific ICFs are provided (examples: EN, FR, NL, PL, GR, HU, DE as indicated by document titles). No details on assent for minors or specific procedures for legal representatives are provided in the JSON.

Geography

Total Number Of Sites
76
Total Number Of Participants
259

Portugal

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
18-11-2024
Processing Time Days
259
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Hospital Da Luz S.A.
Department Name
Oncologia
Principal Investigator Name
Catarina Pulido
Principal Investigator Email
catarina.pulido@hospitaldaluz.pt
Contact Person Name
Catarina Pulido
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Oncologia Médica
Principal Investigator Name
Maria Cassiano Neves
Principal Investigator Email
maria.cassiano.neves@ipoporto.min-saude.pt
Contact Person Name
Maria Cassiano Neves
Site Name
Hospital De Santa Maria E.P.E.
Department Name
Oncologia Médica
Principal Investigator Name
Catarina Abreu
Principal Investigator Email
catarinaabreupm@gmail.com
Contact Person Name
Catarina Abreu
Contact Person Email
catarinaabreupm@gmail.com
Site Name
Instituto Portugues De Oncologia Coimbra Francisco Gentil E.P.E.
Department Name
Oncologia Médica
Principal Investigator Name
Isabel Pazos
Principal Investigator Email
3217@ipocoimbra.min-saude.pt
Contact Person Name
Isabel Pazos
Contact Person Email
3217@ipocoimbra.min-saude.pt

Belgium

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
20-11-2024
Processing Time Days
261
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Jessa Ziekenhuis
Department Name
Medical Oncology
Principal Investigator Name
Annelies Requilé
Principal Investigator Email
annelies.requile@jessazh.be
Contact Person Name
Annelies Requilé
Contact Person Email
annelies.requile@jessazh.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Principal Investigator Name
François Duhoux
Principal Investigator Email
francois.duhoux@uclouvain.be
Contact Person Name
François Duhoux
Contact Person Email
francois.duhoux@uclouvain.be

Poland

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
18-11-2024
Processing Time Days
259
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej
Principal Investigator Name
Zbigniew Nowecki
Principal Investigator Email
zbigniew.nowecki@pib-nio.pl
Contact Person Name
Zbigniew Nowecki
Contact Person Email
zbigniew.nowecki@pib-nio.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Principal Investigator Name
Jacek Jassem
Principal Investigator Email
jjassem@gumed.edu.pl
Contact Person Name
Jacek Jassem
Contact Person Email
jjassem@gumed.edu.pl
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Szpital Morski im.PCK O. Onkologii i Radioterapii, O. Onkologii Klinicznej-Leczenie "Jednego Dnia"
Principal Investigator Name
Joanna Pikiel
Principal Investigator Email
info.onkocwbk@szpitalepomorskie.eu
Contact Person Name
Joanna Pikiel

Greece

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
04-12-2024
Processing Time Days
275
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
St Savas Hospital
Department Name
A’ Department of Oncology
Principal Investigator Name
Alexandros Ardavanis
Principal Investigator Email
ardavanis@yahoo.com
Contact Person Name
Alexandros Ardavanis
Contact Person Email
ardavanis@yahoo.com
Site Name
St Savas Hospital
Department Name
2nd Department of Medical Oncology
Principal Investigator Name
Dimitrios Tryfonopoulos
Principal Investigator Email
oncology2@agsavvas-hosp.gr
Contact Person Name
Dimitrios Tryfonopoulos
Contact Person Email
oncology2@agsavvas-hosp.gr
Site Name
Athens Medical Center S.A.
Department Name
3rd Department of Oncology
Principal Investigator Name
Konstantinos Papazisis
Principal Investigator Email
k.papazisis@oncomedicare.com
Contact Person Name
Konstantinos Papazisis
Contact Person Email
k.papazisis@oncomedicare.com

Italy

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
02-12-2024
Processing Time Days
273
Number Of Sites
11
Number Of Participants
54

Sites

Site Name
IRCCS Ospedale Sacro Cuore Don Calabria
Department Name
UOC Oncologia Medica
Principal Investigator Name
Stefania Gori
Principal Investigator Email
stefania.gori@sacrocuore.it
Contact Person Name
Stefania Gori
Contact Person Email
stefania.gori@sacrocuore.it
Site Name
Istituto Oncologico Veneto
Department Name
Medical Oncology 2
Principal Investigator Name
Valentina Guarneri
Principal Investigator Email
valentina.guarneri@unipd.it
Contact Person Name
Valentina Guarneri
Contact Person Email
valentina.guarneri@unipd.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Oncologia Medica
Principal Investigator Name
Marina Elena Cazzaniga
Principal Investigator Email
marinaelena.cazzaniga@irccs-sangerardo.it
Contact Person Name
Marina Elena Cazzaniga
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
Oncologia Medica
Principal Investigator Name
Vanesa Gregorc
Principal Investigator Email
vanesa.gregorc@ircc.it
Contact Person Name
Vanesa Gregorc
Contact Person Email
vanesa.gregorc@ircc.it
Site Name
Azienda Unita' Locale Socio Sanitaria N. 8 Berica
Department Name
Medical Oncology
Principal Investigator Name
Lucia Borgato
Principal Investigator Email
lucia.borgato@aulss8.veneto.it
Contact Person Name
Lucia Borgato
Contact Person Email
lucia.borgato@aulss8.veneto.it
Site Name
Humanitas Istituto Clinico Catanese S.p.A.
Department Name
Oncologia Medica
Principal Investigator Name
Michele Caruso
Principal Investigator Email
michele.caruso@ccocatania.it
Contact Person Name
Michele Caruso
Contact Person Email
michele.caruso@ccocatania.it
Site Name
European Institute Of Oncology S.r.l.
Department Name
Senologia Medica
Principal Investigator Name
Marco Angelo Colleoni
Principal Investigator Email
marco.colleoni@ieo.it
Contact Person Name
Marco Angelo Colleoni
Contact Person Email
marco.colleoni@ieo.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Urologic and gynecologic oncology
Principal Investigator Name
Michela Palleschi
Principal Investigator Email
michela.palleschii@irst.emr.it
Contact Person Name
Michela Palleschi
Contact Person Email
michela.palleschii@irst.emr.it
Site Name
Azienda Unita Sanitaria Locale Toscana Nord Ovest
Department Name
U.O.C. Oncologia Medica
Principal Investigator Name
Luigi Coltelli
Principal Investigator Email
luigi.coltelli@uslnordovest.toscana.it
Contact Person Name
Luigi Coltelli
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
O.U. Oncology Department
Principal Investigator Name
Rebecca Pedersini
Principal Investigator Email
rebecca.pedersini@hotmail.it
Contact Person Name
Rebecca Pedersini
Contact Person Email
rebecca.pedersini@hotmail.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Medical Oncology 2
Principal Investigator Name
Patrizia Vici
Principal Investigator Email
patrizia.vici@ifo.gov.it
Contact Person Name
Patrizia Vici
Contact Person Email
patrizia.vici@ifo.gov.it

France

Earliest CTIS Part Ii Submission Date
26-03-2024
Latest Decision Or Authorization Date
22-11-2024
Processing Time Days
241
Number Of Sites
11
Number Of Participants
27

Sites

Site Name
Institut De Cancerologie De Lorraine
Department Name
Oncologie Medicale
Principal Investigator Name
Lionel Uwer
Principal Investigator Email
l.uwer@nancy.unicancer.fr
Contact Person Name
Lionel Uwer
Contact Person Email
l.uwer@nancy.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
ONCOLOGIE MEDICALE
Principal Investigator Name
Nicolas Isambert
Principal Investigator Email
nicolas.isambert@chu-poitiers.fr
Contact Person Name
Nicolas Isambert
Site Name
Institut Godinot
Department Name
ONCOLOGIE MEDICALE
Principal Investigator Name
Pauline Soibinet
Principal Investigator Email
pauline.soibinet@reims.unicancer.fr
Contact Person Name
Pauline Soibinet
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
ONCOLOGIE
Principal Investigator Name
Pauline Corbaux
Principal Investigator Email
pauline.corbaux@chu-st-etienne.fr
Contact Person Name
Pauline Corbaux
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Unité de Recherche Clinique Onco-Hematologie
Principal Investigator Name
Frank Priou
Principal Investigator Email
frank.priou@chd-vendee.fr
Contact Person Name
Frank Priou
Contact Person Email
frank.priou@chd-vendee.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Service d'oncologie
Principal Investigator Name
Véronique Diéras
Principal Investigator Email
v.dieras@rennes.unicancer.fr
Contact Person Name
Véronique Diéras
Contact Person Email
v.dieras@rennes.unicancer.fr
Site Name
Centre Hospitalier Du Puy
Department Name
Oncologie et chimiothérapie
Principal Investigator Name
Kheir-Eddine Benmammar
Principal Investigator Email
kheireddine.benmammar@ch-lepuy.fr
Contact Person Name
Kheir-Eddine Benmammar
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Oncologie
Principal Investigator Name
William Jacot
Principal Investigator Email
William.Jacot@icm.unicancer.fr
Contact Person Name
William Jacot
Contact Person Email
William.Jacot@icm.unicancer.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie Medicale
Principal Investigator Name
Paule Augereau
Principal Investigator Email
paule.augereau@ico.unicancer.fr
Contact Person Name
Paule Augereau
Site Name
Centre Hospitalier De La Cote Basque
Department Name
ONCOLOGIE
Principal Investigator Name
Thomas Grellety
Principal Investigator Email
tgrellety@ch-cotebasque.fr
Contact Person Name
Thomas Grellety
Contact Person Email
tgrellety@ch-cotebasque.fr
Site Name
Institut Regional Du Cancer De Montpellier (additional/duplicate entry in record)
Department Name
Oncologie
Principal Investigator Name
William Jacot
Principal Investigator Email
William.Jacot@icm.unicancer.fr
Contact Person Name
William Jacot
Contact Person Email
William.Jacot@icm.unicancer.fr

Hungary

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
18-11-2024
Processing Time Days
259
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Budapesti Uzsoki Utcai Korhaz
Department Name
Onkoradiológiai Osztály
Principal Investigator Name
Timea Klinko
Principal Investigator Email
klinko@uzsoki.hu
Contact Person Name
Timea Klinko
Contact Person Email
klinko@uzsoki.hu
Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
Onkologia osztaly
Principal Investigator Name
Zsuzsanna Papai
Principal Investigator Email
trial.zspapai@gmail.com
Contact Person Name
Zsuzsanna Papai
Contact Person Email
trial.zspapai@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
10-02-2025
Processing Time Days
343
Number Of Sites
15
Number Of Participants
62

Sites

Site Name
Parc Tauli Hospital Universitari
Department Name
Oncology
Principal Investigator Name
Elsa Dalmau Portulas
Principal Investigator Email
edalmau@tauli.cat
Contact Person Name
Elsa Dalmau Portulas
Contact Person Email
edalmau@tauli.cat
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Principal Investigator Name
Estela Vega Alonso
Principal Investigator Email
evega@hmhospitales.com
Contact Person Name
Estela Vega Alonso
Contact Person Email
evega@hmhospitales.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Meritxell Bellet Ezquerra
Principal Investigator Email
mbellet@vhio.net
Contact Person Name
Meritxell Bellet Ezquerra
Contact Person Email
mbellet@vhio.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Principal Investigator Name
Manuel Ruiz Borrego
Principal Investigator Email
ruizsabater@gmail.com
Contact Person Name
Manuel Ruiz Borrego
Contact Person Email
ruizsabater@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Principal Investigator Name
Silvia Antolin Novoa
Principal Investigator Email
silvia.antolin.novoa@sergas.es
Contact Person Name
Silvia Antolin Novoa
Contact Person Email
silvia.antolin.novoa@sergas.es
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncology
Principal Investigator Name
Lucía González Cortijo
Principal Investigator Email
lucia.gonzalezc@quironsalud.es
Contact Person Name
Lucía González Cortijo
Contact Person Email
lucia.gonzalezc@quironsalud.es
Site Name
Hospital Universitario Donostia
Department Name
Oncology
Principal Investigator Name
Isabel Álvarez López
Principal Investigator Email
isabelmanuela.alvarezlopez@osakidetza.eus
Contact Person Name
Isabel Álvarez López
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
Elena López Miranda
Principal Investigator Email
elemiranda@hotmail.com
Contact Person Name
Elena López Miranda
Contact Person Email
elemiranda@hotmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Principal Investigator Name
Begoña Bermejo De Las Heras
Principal Investigator Email
begobermejo@gmail.com
Contact Person Name
Begoña Bermejo De Las Heras
Contact Person Email
begobermejo@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Rafael Villanueva Vázquez
Principal Investigator Email
ravillanueva@iconcologia.net
Contact Person Name
Rafael Villanueva Vázquez
Contact Person Email
ravillanueva@iconcologia.net
Site Name
Hospital Del Mar
Department Name
Oncology
Principal Investigator Name
Sonia Servitja Tormo
Principal Investigator Email
sservitja@psmar.cat
Contact Person Name
Sonia Servitja Tormo
Contact Person Email
sservitja@psmar.cat
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology
Principal Investigator Name
José Manuel Pérez García
Principal Investigator Email
josemanuel.perez@ibcc.clinic
Contact Person Name
José Manuel Pérez García
Contact Person Email
josemanuel.perez@ibcc.clinic
Site Name
MD Anderson Cancer Center (Spain)
Department Name
Oncology
Principal Investigator Name
Isabel Calvo Plaza
Principal Investigator Email
micalvop@mdanderson.es
Contact Person Name
Isabel Calvo Plaza
Contact Person Email
micalvop@mdanderson.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Sara Lopez -Tarruella Cobo
Principal Investigator Email
sara.lopeztarruella@salud.madrid.org
Contact Person Name
Sara Lopez -Tarruella Cobo
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Principal Investigator Name
José Ángel García Sáenz
Principal Investigator Email
jgsaenz@salud.madrid.org
Contact Person Name
José Ángel García Sáenz
Contact Person Email
jgsaenz@salud.madrid.org

Denmark

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
21-02-2025
Processing Time Days
354
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Odense University Hospital
Department Name
Onkologisk Afdeling R
Principal Investigator Name
Annette Raskov Kodahl
Principal Investigator Email
annette.kodahl@rsyd.dk
Contact Person Name
Annette Raskov Kodahl
Contact Person Email
annette.kodahl@rsyd.dk
Site Name
Næstved Hospital
Department Name
Onkologisk Afdeling
Principal Investigator Name
Anne-Cathrine Oestby
Principal Investigator Email
anboe@regionsjaelland.dk
Contact Person Name
Anne-Cathrine Oestby
Contact Person Email
anboe@regionsjaelland.dk
Site Name
Herlev Hospital
Department Name
Afdeling for kræftbehandling
Principal Investigator Name
Gosia Tuxen
Principal Investigator Email
malgorzata.tuxen@regionh.dk
Contact Person Name
Gosia Tuxen
Contact Person Email
malgorzata.tuxen@regionh.dk

Germany

Earliest CTIS Part Ii Submission Date
20-03-2024
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
560
Number Of Sites
19
Number Of Participants
57

Sites

Site Name
Institut Fuer Versorgungsforschung In Der Onkologie GbR
Department Name
N.A.
Principal Investigator Name
Rudolf Weide
Principal Investigator Email
info@invo-koblenz.de
Contact Person Name
Rudolf Weide
Contact Person Email
info@invo-koblenz.de
Site Name
Gemeinschaftspraxis Fuer Haematologie Und Onkologie
Department Name
N.A.
Principal Investigator Name
Andreas Köhler
Principal Investigator Email
info@onkologie-langen.de
Contact Person Name
Andreas Köhler
Contact Person Email
info@onkologie-langen.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Paul Gaß
Principal Investigator Email
paul.gass@skc.de
Contact Person Name
Paul Gaß
Contact Person Email
paul.gass@skc.de
Site Name
Studienzentrum Onkologie Ravensburg GmbH
Department Name
N.A.
Principal Investigator Name
Thomas Decker
Principal Investigator Email
info@onkonet.eu
Contact Person Name
Thomas Decker
Contact Person Email
info@onkonet.eu
Site Name
Universitat Heidelberg
Department Name
Frauenklinik
Principal Investigator Name
Frederik Marmé
Principal Investigator Email
frederik.marme@umm.de
Contact Person Name
Frederik Marmé
Contact Person Email
frederik.marme@umm.de
Site Name
National Center For Tumor Diseases (NCT) Heidelberg
Department Name
Sektion Gynäkologische Onkologie
Principal Investigator Name
Andreas Schneeweiss
Principal Investigator Email
andreas.schneeweiss@med.uni-heidelberg.de
Contact Person Name
Andreas Schneeweiss
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik und Poliklinik für Gynäkologie
Principal Investigator Name
Volkmar Müller
Principal Investigator Email
frauenklinik@uke.de
Contact Person Name
Volkmar Müller
Contact Person Email
frauenklinik@uke.de
Site Name
Franziskus Hospital Harderberg
Department Name
Zentrum für Onkologie und Hämatologie MVZ II
Principal Investigator Name
Kerstin Luedtke-Heckenkamp
Principal Investigator Email
onkologie@nsk.de
Contact Person Name
Kerstin Luedtke-Heckenkamp
Contact Person Email
onkologie@nsk.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Frauenklinik & Poliklinik
Principal Investigator Name
Eva-Maria Grischke
Principal Investigator Email
Eva-maria.grischke@med.uni-tuebingen.de
Contact Person Name
Eva-Maria Grischke
Site Name
Praxisnetzwerk Hämatologie und intern. Onkologie
Department Name
Standort Troisdorf
Principal Investigator Name
Helmut Forstbauer
Principal Investigator Email
info@onkologie-rheinsieg.de
Contact Person Name
Helmut Forstbauer
Contact Person Email
info@onkologie-rheinsieg.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Oliver Hoffmann
Principal Investigator Email
oliver.hoffmann@uk-essen.de
Contact Person Name
Oliver Hoffmann
Contact Person Email
oliver.hoffmann@uk-essen.de
Site Name
Ambulantes Tumorzentrum Spandau
Department Name
N.A.
Principal Investigator Name
Uwe Peters
Principal Investigator Email
info@onkologie-spandau.de
Contact Person Name
Uwe Peters
Contact Person Email
info@onkologie-spandau.de
Site Name
Technische Universitat Dresden
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Pauline Wimberger
Principal Investigator Email
studiensekretariat.gyn@ukdd.de
Contact Person Name
Pauline Wimberger
Contact Person Email
studiensekretariat.gyn@ukdd.de
Site Name
Medizinische Hochschule Hannover
Department Name
Zentrum für Frauenheilkunde Abteilung Gynäkologische Onkologie
Principal Investigator Name
Tjoung-Won Park-Simon
Principal Investigator Email
gynaekologische-onkologie@mh-hannover.de
Contact Person Name
Tjoung-Won Park-Simon
Site Name
Facharztzentrum Eppendorf
Department Name
NORDDEUTSCHES STUDIENZENTRUM FÜR INNOVATIVE ONKOLOGIE
Principal Investigator Name
Alexander Stein
Principal Investigator Email
goekkurt@hope-hamburg.de
Contact Person Name
Alexander Stein
Contact Person Email
goekkurt@hope-hamburg.de
Site Name
St. Elisabeth-Krankenhaus Leipzig gGMbH
Department Name
Senologie/Brustzentrum
Principal Investigator Name
Dagmar Langanke
Principal Investigator Email
senologie@ek-leipzig.de
Contact Person Name
Dagmar Langanke
Contact Person Email
senologie@ek-leipzig.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde u Geburtshilfe
Principal Investigator Name
Nadia Harbeck
Principal Investigator Email
brustzentrum@med.uni-muenchen.de
Contact Person Name
Nadia Harbeck
Site Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Department Name
Innere Medizin 1
Principal Investigator Name
Tobias Buss
Principal Investigator Email
tobias.buss@mutterhaus.de
Contact Person Name
Tobias Buss
Contact Person Email
tobias.buss@mutterhaus.de

Austria

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
756
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Medical University of Vienna
Department Name
Department of Internal Medicine I
Principal Investigator Name
Rupert Bartsch
Principal Investigator Email
sekretariat_onko@meduniwien.ac.at
Contact Person Name
Rupert Bartsch
Site Name
Oberoesterreichische Gesundheitsholding GmbH
Department Name
Department of Internal Medicine II
Principal Investigator Name
Dieter Rossmann
Principal Investigator Email
brustzentrum.sr@ooeg.at
Contact Person Name
Dieter Rossmann
Contact Person Email
brustzentrum.sr@ooeg.at
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Department of Internal Medicine III
Principal Investigator Name
Simon Gampenrieder
Principal Investigator Email
s.gampenrieder@salk.at
Contact Person Name
Simon Gampenrieder
Contact Person Email
s.gampenrieder@salk.at

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Responsibilities
ECG Provider
Name
Almac Clinical Technologies LLC
Responsibilities
code: 3

Third parties

  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Median Technologies","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement & Travel","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"ECG Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code: 3","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
RO7197597
Active Substance
GIREDESTRANT
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
30 mg
Investigational Product Name
IBRANCE 75 mg hard capsules / IBRANCE 100 mg hard capsules / IBRANCE 125 mg hard capsules / IBRANCE 75 mg film-coated tablets / IBRANCE 100 mg film-coated tablets / IBRANCE 125 mg film-coated tablets
Active Substance
PALBOCICLIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation numbers present for multiple formulations (examples: EU/1/16/1147/* as listed in product dictionary entries)
Maximum Dose
125 mg
Investigational Product Name
Femara® 2,5 mg Filmtabletten
Active Substance
LETROZOLE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation number: 38895.00.00 (as listed in product dictionary entry)
Maximum Dose
2.5 mg
Investigational Product Name
Placebo Giredestrant
Modality
Other
Investigational Product Name
Placebo Letrozole
Modality
Other
Combination Treatment
Yes

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