Clinical trial • Phase III • Oncology

CAPIVASERTIB for Breast cancer (hormone receptor-positive, HER2−), locally advanced or metastatic

Phase III trial of CAPIVASERTIB for Breast cancer (hormone receptor-positive, HER2−), locally advanced or metastatic.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Breast cancer (hormone receptor-positive, HER2−), locally advanced or metastatic
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
22-12-2023
First CTIS Authorization Date
14-02-2024

Trial design

Randomised, placebo + fulvestrant (faslodex 250 mg solution for injection) versus capivasertib + fulvestrant (capivasertib oral film-coated tablet + faslodex 250 mg im). specific dosing schedule for capivasertib and fulvestrant schedule not specified in the available ctis data.-controlled Phase III trial in Hungary, Germany, France and others.

Randomised
Yes
Comparator
Placebo + Fulvestrant (Faslodex 250 mg solution for injection) versus Capivasertib + Fulvestrant (Capivasertib oral film-coated tablet + Faslodex 250 mg IM). Specific dosing schedule for capivasertib and fulvestrant schedule not specified in the available CTIS data.
Biomarker Stratified
True, PIK3CA/AKT1/PTEN alteration status (PIK3CA/AKT1/PTEN-altered vs non-altered) as a subgroup of interest
Target Sample Size
334

Eligibility

Recruits 334 Vulnerable population flag selected in registry. Study enrols adults only (adult females and adult males). Separate informed consent documents are available (subject information and ICFs); country-specific ICFs and versions include dedicated 'Pregnant Partner ICF' and separate 'Optional Genetic Research ICF' documents, indicating special consent handling for pregnant partners and optional genetic research. No assent procedure for minors is provided (adults only)..

Pregnancy Exclusion
Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
Vulnerable Population
Vulnerable population flag selected in registry. Study enrols adults only (adult females and adult males). Separate informed consent documents are available (subject information and ICFs); country-specific ICFs and versions include dedicated 'Pregnant Partner ICF' and separate 'Optional Genetic Research ICF' documents, indicating special consent handling for pregnant partners and optional genetic research. No assent procedure for minors is provided (adults only).

Inclusion criteria

  • {"criterion_text":"- Adult females, pre- and/or post-menopausal, and adult males. Premenopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study.\n- Histologically confirmed HR+/HER2− breast cancer determined from the most recent tumour sample (primary or metastatic), as per the American Society of Clinical Oncology and College of American Pathologists guideline recommendations. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without coexpression of progesterone receptor.\n- Metastatic or locally advanced disease with radiological or objective evidence of recurrence or progression (the cancer should have shown progression during or after most recent therapy); locally advanced disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible).\n- ECOG/WHO PS: 0-1\n- Patients are to have received treatment with an AI (aromatase inhibitor) containing regimen (single agent or in combination) and have: a) Radiological evidence of breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an AI, OR b) Radiological evidence of progression while on prior AI administered as a treatment line for locally advanced or metastatic breast cancer (this does not need to be the most recent therapy).\n- Patients must have measurable disease according to RECIST 1.1 and/or at least 1 lytic or mixed (lytic + sclerotic) bone lesion that can be assessed by CT or MRI; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible.\n- FFPE tumour sample from primary/recurrent cancer for central testing."}

Exclusion criteria

  • {"criterion_text":"- Symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgement.\n- Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or LHRH agonist (if applicable).\n- Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.\n- More than 2 lines of endocrine therapy for inoperable locally advanced or metastatic disease.\n- More than 1 line of chemotherapy for inoperable locally advanced or metastatic disease. Adjuvant and neoadjuvant chemotherapy are not classed as lines of chemotherapy for advanced breast cancer.\n- Prior treatment with any of the following: a) AKT, PI3K and mTOR inhibitors b) Fulvestrant, and other SERDs c) Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks prior to study treatment initiation. d) Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort) or drugs that are sensitive to CYP3A within 1 week prior to study treatment initiation.\n- Radiotherapy with a wide field of radiation up to 4 weeks before study treatment initiation (capivasertib/placebo) and/or radiotherapy with a limited field of radiation for palliation up to 2 weeks before study treatment initiation (capivasertib/placebo).\n- With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE \\ grade 1 at the time of starting study treatment.\n- Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids up to 4 weeks before study treatment initiation.\n- Any of the following cardiac criteria: a) Mean resting QT interval corrected by Fridericia's formula (QTcF) >470 msec obtained from 3 consecutive ECGs b) Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block) c) Any factors that increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for torsades of pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval d) Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) grade ≥2 e) Uncontrolled hypotension – systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg f) Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition [MUGA] scan if an echocardiogram cannot be performed or is inconclusive).\n- Clinically significant abnormalities of glucose metabolism as defined by any of the following: a) Patients with diabetes mellitus type 1 or diabetes mellitus type 2 requiring insulin treatment b) HbA1c ≥8.0% (63.9 mmol/mol)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS) is defined as the time from randomisation until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause.","definition_or_measurement_approach":"Defined as time from randomisation to progression per RECIST v1.1 assessed by local investigator, or death from any cause."}

Secondary endpoints

  • {"endpoint_text":"- OS, overall survival","definition_or_measurement_approach":"Overall survival (time from randomisation to death from any cause)."}
  • {"endpoint_text":"- PFS2, time from randomisation to second progression or death.","definition_or_measurement_approach":"Time from randomisation to second progression or death (PFS2)."}
  • {"endpoint_text":"- ORR, objective response rate.","definition_or_measurement_approach":"Objective response rate (ORR) per response assessment criteria (RECIST v1.1 implied)."}
  • {"endpoint_text":"- DoR, duration of response.","definition_or_measurement_approach":"Duration of response (DoR)."}
  • {"endpoint_text":"- CBR, clinical benefit rate.","definition_or_measurement_approach":"Clinical benefit rate (CBR)."}
  • {"endpoint_text":"- Safety and tolerability evaluated as AEs/SAEs, vital signs, clinical chemistry/haematology/glucose metabolism parameters, and ECG parameters.","definition_or_measurement_approach":"Safety assessed by adverse events (AEs/SAEs), vital signs, clinical chemistry/haematology/glucose metabolism parameters, and ECG parameters."}
  • {"endpoint_text":"- Plasma concentration of capivasertib.","definition_or_measurement_approach":"Pharmacokinetic measurement: plasma concentration of capivasertib."}
  • {"endpoint_text":"- EORTC QLQ-C30, EORTC Quality of Life Questionnaire-Core 30 items and EORTC QLQ-BR23, EORTC Quality of Life Questionnaire breast cancer specific module,scale/item scores.","definition_or_measurement_approach":"Patient-reported outcomes assessed by EORTC QLQ-C30 and QLQ-BR23 (scale/item scores, change from baseline and time to deterioration)."}
  • {"endpoint_text":"- Deterioration of ECOG, Eastern Cooperative Oncology Group, performance status.","definition_or_measurement_approach":"Time to definitive deterioration of ECOG performance status from baseline."}

Recruitment

Planned Sample Size
334
Recruitment Window Months
63
Consent Approach
Informed consent obtained using subject information sheets and informed consent forms (ICFs). Multiple country-specific ICFs are available (examples: HU, DE, BE, FR, ES, PL, EN versions listed). Separate ICFs are provided for Pregnant Partner information and for Optional Genetic Research, indicating dedicated consent processes for those elements. All participants are adults and provide their own consent; no minor assent procedures are documented.

Geography

Total Number Of Sites
72
Total Number Of Participants
366

Hungary

Earliest CTIS Part Ii Submission Date
15-02-2024
Latest Decision Or Authorization Date
17-07-2025
Processing Time Days
518
Number Of Sites
6
Number Of Participants
42

Sites

Site Name
University Of Debrecen
Department Name
Oncology
Principal Investigator Name
Peter Arkosy
Principal Investigator Email
arkosy.peter@med.unideb.hu
Contact Person Name
Peter Arkosy
Contact Person Email
arkosy.peter@med.unideb.hu
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Oncology
Principal Investigator Name
Zsolt Horvath
Principal Investigator Email
horvathzso@kmk.hu
Contact Person Name
Zsolt Horvath
Contact Person Email
horvathzso@kmk.hu
Site Name
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Department Name
Oncology
Principal Investigator Name
Aniko Ragalyi
Principal Investigator Email
szolnok.onkologia@gmail.com
Contact Person Name
Aniko Ragalyi
Contact Person Email
szolnok.onkologia@gmail.com
Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
Oncology
Principal Investigator Name
Zsuzsanna Papai
Principal Investigator Email
trial.zspapai@gmail.com
Contact Person Name
Zsuzsanna Papai
Contact Person Email
trial.zspapai@gmail.com
Site Name
Tolna Varmegyei Balassa Janos Korhaz
Department Name
Oncology
Principal Investigator Name
Yousuf Al-Farhat
Principal Investigator Email
yalfarhat@gmail.com
Contact Person Name
Yousuf Al-Farhat
Contact Person Email
yalfarhat@gmail.com
Site Name
Orszagos Onkologiai Intezet
Department Name
Oncology
Principal Investigator Name
Gabor Laszlo Rubovszky
Principal Investigator Email
rubovszky.gabor@oncol.hu
Contact Person Name
Gabor Laszlo Rubovszky
Contact Person Email
rubovszky.gabor@oncol.hu

Germany

Earliest CTIS Part Ii Submission Date
19-02-2024
Latest Decision Or Authorization Date
16-07-2025
Processing Time Days
513
Number Of Sites
15
Number Of Participants
72

Sites

Site Name
Hämatologisch-Onkologische Praxis Eppendorf (hope)
Department Name
-
Principal Investigator Name
Eray Gokkurt
Principal Investigator Email
oekkurt@hope-hamburg.de
Contact Person Name
Eray Gokkurt
Contact Person Email
oekkurt@hope-hamburg.de
Site Name
Centrum für Hämatologie und Onkologie Bethanien
Department Name
-
Principal Investigator Name
Hans Tesch
Principal Investigator Email
Onkologie-Frankfurt@telemed.de
Contact Person Name
Hans Tesch
Contact Person Email
Onkologie-Frankfurt@telemed.de
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Frauenklinik
Principal Investigator Name
Frederik Marme
Principal Investigator Email
Frederik.Marme@umm.de
Contact Person Name
Frederik Marme
Contact Person Email
Frederik.Marme@umm.de
Site Name
Medizinische Hochschule Hannover
Department Name
Gynakologische Onkologie
Principal Investigator Name
Tjoung-Won Park-Simon
Principal Investigator Email
park-simon.tjoung-won@mh-hannover.de
Contact Person Name
Tjoung-Won Park-Simon
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik fur Senologie/Interdisziplinares Brustkrebszentrum
Principal Investigator Name
Sherko Kuemmel
Principal Investigator Email
s.kuemmel@kem-med.com
Contact Person Name
Sherko Kuemmel
Contact Person Email
s.kuemmel@kem-med.com
Site Name
Mammazentrum Hamburg MVZ GbR
Department Name
-
Principal Investigator Name
Christian Schem
Principal Investigator Email
schem@mammazentrum.eu
Contact Person Name
Christian Schem
Contact Person Email
schem@mammazentrum.eu
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Frauenklinik
Principal Investigator Name
Peter Fasching
Principal Investigator Email
peter.fasching.studien@uk-erlangen.de
Contact Person Name
Peter Fasching
Site Name
Muhlenkreiskliniken AöR
Department Name
Brustzentrum Minden-Herford
Principal Investigator Name
Martin Griesshammer
Contact Person Name
Martin Griesshammer
Site Name
St. Vincenz-Krankenhaus GmbH
Department Name
Klinik fur Gynakologie und Geburtshilfe
Principal Investigator Name
Michael Patrick Lux
Principal Investigator Email
m.lux@vincenz.de
Contact Person Name
Michael Patrick Lux
Contact Person Email
m.lux@vincenz.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Klinik fur Frauenheilkunde und Geburtshilfe Bereich Senologie
Principal Investigator Name
Joke Tio
Principal Investigator Email
joke.tio@ukmuenster.de
Contact Person Name
Joke Tio
Contact Person Email
joke.tio@ukmuenster.de
Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
Klinik fur Gynakologie und Geburtshilfe
Principal Investigator Name
Marion Tina van Mackelenbergh
Principal Investigator Email
MarionTina.vanMackelenbergh@uksh.de
Contact Person Name
Marion Tina van Mackelenbergh
Site Name
National Center For Tumor Diseases (NCT) Heidelberg
Department Name
Gynecologic Oncology
Principal Investigator Name
Andreas Schneeweiss
Principal Investigator Email
andreas.schneeweiss@nct-heidelberg.de
Contact Person Name
Andreas Schneeweiss
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Pauline Wimberger
Principal Investigator Email
pauline.wimberger@uniklinikum-dresden.de
Contact Person Name
Pauline Wimberger
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik für Gynakologie
Principal Investigator Name
Volkmar Müller
Principal Investigator Email
v.mueller@uke.de
Contact Person Name
Volkmar Müller
Contact Person Email
v.mueller@uke.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe Brustzentrum
Principal Investigator Name
Nadia Harbeck
Principal Investigator Email
nadia.harbeck@med.uni-muenchen.de
Contact Person Name
Nadia Harbeck

France

Earliest CTIS Part Ii Submission Date
16-02-2024
Latest Decision Or Authorization Date
21-07-2025
Processing Time Days
521
Number Of Sites
10
Number Of Participants
36

Sites

Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
-
Principal Investigator Name
Florence Dalenc
Principal Investigator Email
dalenc.florence@iuct-oncopole.fr
Contact Person Name
Florence Dalenc
Site Name
Centre Hospitalier Lyon Sud
Department Name
-
Principal Investigator Name
Julien Peron
Principal Investigator Email
julien.peron@chu-lyon.fr
Contact Person Name
Julien Peron
Contact Person Email
julien.peron@chu-lyon.fr
Site Name
Centre Henri Becquerel
Department Name
-
Principal Investigator Name
Jean-Christophe Thery
Principal Investigator Email
jean-christophe.thery@chb.unicancer.fr
Contact Person Name
Jean-Christophe Thery
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
-
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
Centre Hospitalier Annecy Genevois
Department Name
-
Principal Investigator Name
Laetitia Stefani
Principal Investigator Email
lstefani@ch-annecygenevois.fr
Contact Person Name
Laetitia Stefani
Contact Person Email
lstefani@ch-annecygenevois.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
-
Principal Investigator Name
Thierry Petit
Principal Investigator Email
t.petit@icans.eu
Contact Person Name
Thierry Petit
Contact Person Email
t.petit@icans.eu
Site Name
Centre Hospital Region Metz Thionville
Department Name
-
Principal Investigator Name
Elisabeth Luporsi
Principal Investigator Email
e.luporsi@chr-metz-thionville.fr
Contact Person Name
Elisabeth Luporsi
Site Name
Besancon University Hospital Center
Department Name
-
Principal Investigator Name
Guillaume Meynard
Principal Investigator Email
gmeynard@chu-besancon.fr
Contact Person Name
Guillaume Meynard
Contact Person Email
gmeynard@chu-besancon.fr
Site Name
Hopital Prive Des Cotes D'armor
Department Name
-
Principal Investigator Name
Anne-Claire Hardy-Bessard
Principal Investigator Email
ac.hardy@cario-sante.fr
Contact Person Name
Anne-Claire Hardy-Bessard
Contact Person Email
ac.hardy@cario-sante.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
-
Principal Investigator Name
Lucie Monceau-Baroux
Principal Investigator Email
lucie.monceau-baroux@chu-brest.fr
Contact Person Name
Lucie Monceau-Baroux

Belgium

Earliest CTIS Part Ii Submission Date
19-02-2024
Latest Decision Or Authorization Date
01-08-2025
Processing Time Days
529
Number Of Sites
4
Number Of Participants
34

Sites

Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
-
Principal Investigator Name
Claire Quaghebeur
Principal Investigator Email
claire.quaghebeur@uclouvain.be
Contact Person Name
Claire Quaghebeur
Contact Person Email
claire.quaghebeur@uclouvain.be
Site Name
Grand Hopital De Charleroi
Department Name
-
Principal Investigator Name
Jean-Luc Canon
Principal Investigator Email
canon.jl@ghdc.be
Contact Person Name
Jean-Luc Canon
Contact Person Email
canon.jl@ghdc.be
Site Name
Antwerp University Hospital
Department Name
-
Principal Investigator Name
Konstantinos Papadimitriou
Principal Investigator Email
konstantinos.papadimitriou@uza.be
Contact Person Name
Konstantinos Papadimitriou
Site Name
Cliniques Universitaires Saint-Luc
Department Name
-
Principal Investigator Name
Francois Duhoux
Principal Investigator Email
francois.duhoux@uclouvain.be
Contact Person Name
Francois Duhoux
Contact Person Email
francois.duhoux@uclouvain.be

Poland

Earliest CTIS Part Ii Submission Date
16-02-2024
Latest Decision Or Authorization Date
18-07-2025
Processing Time Days
518
Number Of Sites
3
Number Of Participants
22

Sites

Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Poradnia Onkologiczna i Oddział Kliniczny Onkologii
Principal Investigator Name
Piotr Wysocki
Principal Investigator Email
piotr.wysocki@uj.edu.pl
Contact Person Name
Piotr Wysocki
Contact Person Email
piotr.wysocki@uj.edu.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Principal Investigator Name
Bogdan Zurawski
Principal Investigator Email
zurawskib@co.bydgoszcz.pl
Contact Person Name
Bogdan Zurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
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
nowecki@coi.waw.pl
Contact Person Name
Zbigniew Nowecki
Contact Person Email
nowecki@coi.waw.pl

Spain

Earliest CTIS Part Ii Submission Date
14-02-2024
Latest Decision Or Authorization Date
16-07-2025
Processing Time Days
518
Number Of Sites
24
Number Of Participants
96

Sites

Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Principal Investigator Name
Alexandra Cortegoso
Contact Person Name
Alexandra Cortegoso
Site Name
Hospital Quironsalud Barcelona
Department Name
Oncology
Principal Investigator Name
Jesus Soberino
Principal Investigator Email
jesus.soberino@iob-onco.com
Contact Person Name
Jesus Soberino
Contact Person Email
jesus.soberino@iob-onco.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Eva Ciruelos Gil
Principal Investigator Email
eva.ciruelos@gmail.com
Contact Person Name
Eva Ciruelos Gil
Contact Person Email
eva.ciruelos@gmail.com
Site Name
Salut Sant Joan De Reus
Department Name
Oncology
Principal Investigator Name
Mireia Mele Olive
Principal Investigator Email
mireiamele@hotmail.com
Contact Person Name
Mireia Mele Olive
Contact Person Email
mireiamele@hotmail.com
Site Name
Hospital Universitario De Jaen
Department Name
Oncology
Principal Investigator Name
Pedro Sanchez Rovira
Principal Investigator Email
oncopsr@yahoo.es
Contact Person Name
Pedro Sanchez Rovira
Contact Person Email
oncopsr@yahoo.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Principal Investigator Name
Blanca Cantos
Principal Investigator Email
blanca.cantos@salud.madrid.org
Contact Person Name
Blanca Cantos
Contact Person Email
blanca.cantos@salud.madrid.org
Site Name
Hospital Quironsalud Valencia
Department Name
Oncology
Principal Investigator Name
Andres Poveda Velasco
Principal Investigator Email
apoveda@initiaoncologia.com
Contact Person Name
Andres Poveda Velasco
Contact Person Email
apoveda@initiaoncologia.com
Site Name
MD Anderson Cancer Center
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 Universitario Virgen De La Victoria
Department Name
Oncology
Principal Investigator Name
Nuria Ribelles
Principal Investigator Email
nuriaribelles@gmail.com
Contact Person Name
Nuria Ribelles
Contact Person Email
nuriaribelles@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Principal Investigator Name
Juan de la Haba
Principal Investigator Email
juandelahaba@hotmail.com
Contact Person Name
Juan de la Haba
Contact Person Email
juandelahaba@hotmail.com
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Oncology
Principal Investigator Name
Serafín Morales Murillo
Principal Investigator Email
eoncolleida@gmail.com
Contact Person Name
Serafín Morales Murillo
Contact Person Email
eoncolleida@gmail.com
Site Name
Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
Department Name
Oncology
Principal Investigator Name
Margarita Amenedo
Principal Investigator Email
margarita.amenedo@cog.es
Contact Person Name
Margarita Amenedo
Contact Person Email
margarita.amenedo@cog.es
Site Name
Hospital Quironsalud Sagrado Corazon
Department Name
Oncology
Principal Investigator Name
Juan Antonio Virizuela Echaburu
Principal Investigator Email
javirizuelae@seom.org
Contact Person Name
Juan Antonio Virizuela Echaburu
Contact Person Email
javirizuelae@seom.org
Site Name
Hospital Del Mar
Department Name
Oncology
Principal Investigator Name
María Martinez García
Principal Investigator Email
incorrect@na.com
Contact Person Name
María Martinez García
Contact Person Email
incorrect@na.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Silvia Vazquez Fernandez
Principal Investigator Email
silviavazquez@iconcologia.net
Contact Person Name
Silvia Vazquez Fernandez
Contact Person Email
silviavazquez@iconcologia.net
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Principal Investigator Name
Pilar Zamora Aunon
Principal Investigator Email
zamorapilar@gmail.com
Contact Person Name
Pilar Zamora Aunon
Contact Person Email
zamorapilar@gmail.com
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Principal Investigator Name
Jose Angel García Saenz
Principal Investigator Email
jagsaenz@yahoo.com
Contact Person Name
Jose Angel García Saenz
Contact Person Email
jagsaenz@yahoo.com
Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Principal Investigator Name
Jose Juan Illarramendi Manas
Principal Investigator Email
researcherillarramendi@gmail.com
Contact Person Name
Jose Juan Illarramendi Manas
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Pauline Wimberger
Principal Investigator Email
pauline.wimberger@uniklinikum-dresden.de
Contact Person Name
Pauline Wimberger
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
Hospital Universitario De Canarias
Department Name
Oncology
Principal Investigator Name
Josefina Cruz-Jurado
Principal Investigator Email
jcruzjurado@gmail.com
Contact Person Name
Josefina Cruz-Jurado
Contact Person Email
jcruzjurado@gmail.com
Site Name
Hospital Beata Maria Ana
Department Name
Oncology
Principal Investigator Name
Maria Gion Cortes
Principal Investigator Email
mariagion@gmail.com
Contact Person Name
Maria Gion Cortes
Contact Person Email
mariagion@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Mafalda Oliveira
Principal Investigator Email
moliveira@vhio.net
Contact Person Name
Mafalda Oliveira
Contact Person Email
moliveira@vhio.net
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Principal Investigator Name
Angel Guerrero-Zotano
Principal Investigator Email
angel.guerrero.zotano@gmail.com
Contact Person Name
Angel Guerrero-Zotano

Italy

Earliest CTIS Part Ii Submission Date
19-02-2024
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
645
Number Of Sites
10
Number Of Participants
64

Sites

Site Name
Azienda Ospedaliera Papa Giovanni XXIII
Department Name
Medical Oncology unit
Principal Investigator Name
Elena Rota Caremoli
Principal Investigator Email
ecrota@asst-pg23.it
Contact Person Name
Elena Rota Caremoli
Contact Person Email
ecrota@asst-pg23.it
Site Name
Ospedale Generale Provinciale Di Macerata
Department Name
Oncology Unit
Principal Investigator Name
Nicola Battelli
Principal Investigator Email
nicola.battelli@sanita.marche.it
Contact Person Name
Nicola Battelli
Site Name
Azienda Unita Sanitaria Locale 6 Livorno
Department Name
Medical Oncology unit
Principal Investigator Name
Luigi Coltelli
Principal Investigator Email
luigi.coltelli@uslnordovest.toscana.it
Contact Person Name
Luigi Coltelli
Site Name
University Magna Graecia Of Catanzaro
Department Name
Medical Oncology unit
Principal Investigator Name
Pietrosandro Tagliaferri
Principal Investigator Email
tagliaferri@unicz.it
Contact Person Name
Pietrosandro Tagliaferri
Contact Person Email
tagliaferri@unicz.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Medical Oncology unit
Principal Investigator Name
Federico Piacentini
Principal Investigator Email
federico.piacentini@unimore.it
Contact Person Name
Federico Piacentini
Contact Person Email
federico.piacentini@unimore.it
Site Name
Universita' Campus Bio-medico Di Roma
Department Name
Medical Oncology unit
Principal Investigator Name
Giuseppe Tonini
Principal Investigator Email
g.tonini@policlinicocampus.it
Contact Person Name
Giuseppe Tonini
Contact Person Email
g.tonini@policlinicocampus.it
Site Name
European Institute Of Oncology S.r.l.
Department Name
Medical Breast Care Unit
Principal Investigator Name
Marco Colleoni
Principal Investigator Email
marco.colleoni@ieo.it
Contact Person Name
Marco 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
Medical Oncology unit
Principal Investigator Name
Ugo De Giorgi
Principal Investigator Email
ugo.degiorgi@irst.emr.it
Contact Person Name
Ugo De Giorgi
Contact Person Email
ugo.degiorgi@irst.emr.it
Site Name
Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Onco-Haematology unit
Principal Investigator Name
Carminia Maria Della Corte
Principal Investigator Email
carminiamaria.dellacorte@unicampania.it
Contact Person Name
Carminia Maria Della Corte
Site Name
Azienda USL Toscana Centro
Department Name
Medical Oncology unit
Principal Investigator Name
Laura Biganzoli
Principal Investigator Email
laura.biganzoli@uslcentro.toscana.it
Contact Person Name
Laura Biganzoli

Sponsor

Primary sponsor

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

Contract research organisations

Name
PAREXEL International GmbH
Responsibilities
Medical image analysis/ review - X-ray, MRI, ultrasound, etc.
Name
Fortrea Inc.
Name
Medidata Solutions Inc.

Third parties

  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"Biomarker analysis by IHC","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"AAC/Proximus","duties_or_roles":"24 hour medical coverage","organisation_type":"Industry"}
  • {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"IXRS Services","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Astrazeneca UK Limited","duties_or_roles":"Exploratory Biomarker Testing using Plasma samples.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"Advanced blood and tissue analytical tests, real-world data and AI analytics.","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"Molecular Testing (NGS)","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"Central samples logistics","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation services","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"PAREXEL International GmbH","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"IP distribution","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Capivasertib
Active Substance
CAPIVASERTIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus:1
Maximum Dose
640 mg; 800 mg (values shown in product entries: maxDailyDoseAmount 640 and 800)
Investigational Product Name
Faslodex 250 mg solution for injection.
Active Substance
FULVESTRANT
Modality
Small molecule
Routes Of Administration
INTRAMUSCULAR USE
Route
Intramuscular
Authorisation Status
marketingAuthNumber: EU/1/03/269/001 (prodAuthStatus:2)
Maximum Dose
500 mg/ml (maxDailyDoseAmount: 500)
Investigational Product Name
Placebo to Capivasertib
Modality
Other
Combination Treatment
Yes

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