Clinical trial • Phase III • Oncology

OP-1250 / PALAZESTRANT for ER-positive, HER2-negative advanced breast cancer

Phase III trial of OP-1250 / PALAZESTRANT for ER-positive, HER2-negative advanced breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
ER-positive, HER2-negative advanced breast cancer
Trial Stage
Phase III
Drug Modality
Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
10-10-2025
First CTIS Authorization Date
17-02-2026

Trial design

Randomised, control arm: letrozole with ribociclib + palazestrant-matching placebo (comparator specified as letrozole with ribociclib; dosing schedules not specified in the ctis record). Phase III trial in Austria, France, Germany and others.

Randomised
Yes
Comparator
Control arm: letrozole with ribociclib + palazestrant-matching placebo (comparator specified as letrozole with ribociclib; dosing schedules not specified in the CTIS record).
Target Sample Size
644

Eligibility

Recruits 644 The CTIS record flags a vulnerable population selection (isVulnerablePopulationSelected: true). The trial enrols adult participants only; no participant assent or minor consent procedures are described in the provided CTIS record. Country-specific subject information and consent materials (including 'Pregnant Partner' documents) are listed in the record, but explicit text describing handling of vulnerable participants, assent, or surrogate consent is not available in the provided data..

Vulnerable Population
The CTIS record flags a vulnerable population selection (isVulnerablePopulationSelected: true). The trial enrols adult participants only; no participant assent or minor consent procedures are described in the provided CTIS record. Country-specific subject information and consent materials (including 'Pregnant Partner' documents) are listed in the record, but explicit text describing handling of vulnerable participants, assent, or surrogate consent is not available in the provided data.

Inclusion criteria

  • {"criterion_text":"- 1. Adult female or male participants.\n- 2. ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.\n- 3. Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).\n- 4. De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors)\n- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n- 6. Adequate hematologic, hepatic, and renal functions.\n- 7. Female participants can be pre-, peri- or postmenopausal.\n- 8. Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist."}

Exclusion criteria

  • {"criterion_text":"- 1. Disease recurrence during adjuvant endocrine therapy\n- 2. Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.\n- 3. Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.\n- 4. History of allergic reactions to study treatment.\n- 5. Any contraindications to letrozole and ribociclib.\n- 6. Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Local Investigator-assessed PFS (Progression-Free Survival)","definition_or_measurement_approach":"PFS (Progression-Free Survival) assessed by the Local Investigator; main objective: to compare PFS based on Local Investigator assessment between investigational (palazestrant with ribociclib + letrozole-matching placebo) and control (letrozole with ribociclib + palazestrant-matching placebo) arms."}

Secondary endpoints

  • {"endpoint_text":"- 1. OS","definition_or_measurement_approach":"Overall Survival (OS); compare OS between investigational and control arms."}
  • {"endpoint_text":"- 2. BIRC-assessed PFS, ORR, DOR and CBR","definition_or_measurement_approach":"Progression-Free Survival (PFS), Objective Response Rate (ORR), Duration of Response (DOR) and Clinical Benefit Rate (CBR) assessed by a Blinded Independent Review Committee (BIRC)."}
  • {"endpoint_text":"- 3. Local Investigator-assessed ORR, DOR, CBR","definition_or_measurement_approach":"ORR, DOR and CBR assessed by the Local Investigator."}
  • {"endpoint_text":"- 4. Safety and tolerability, assessed by AEs, SAEs, dose modifications, clinical laboratory parameters, ECGs, performance status, and vital sign measurements","definition_or_measurement_approach":"Safety and tolerability assessed using adverse events (AEs), serious adverse events (SAEs), dose modifications, clinical laboratory parameters, ECGs, performance status measures and vital signs."}
  • {"endpoint_text":"- 5. Plasma levels of palazestrant and ribociclib (in investigational arm) and of ribociclib (in control arm) at predefined intervals to establish PK parameters.","definition_or_measurement_approach":"Pharmacokinetic assessments: plasma concentrations of palazestrant and ribociclib (investigational arm) and ribociclib (control arm) measured at predefined intervals to derive PK parameters."}
  • {"endpoint_text":"- 6. PRO endpoints, assessed using the EORTC QLQ- C30, EORTC QLQ-BR42 and EQ-5D-5L questionnaires","definition_or_measurement_approach":"Patient-reported outcomes (PROs) measured using EORTC QLQ-C30, EORTC QLQ-BR42 and EQ-5D-5L questionnaires; change from baseline will be evaluated."}
  • {"endpoint_text":"- 7. Time from randomization to disease progression on first subsequent systemic anti-cancer therapy or death","definition_or_measurement_approach":"Time from randomization to progression on first subsequent systemic anti-cancer therapy or death (also referred to as PFS2 in objectives)."}

Recruitment

Planned Sample Size
644
Recruitment Window Months
79
Consent Approach
Informed consent is obtained from adult participants. The CTIS record contains country-specific Subject Information and Informed Consent Forms (SIS-ICF) and related materials in multiple languages (examples in the documents list: German, French, Romanian, Italian, Dutch, Greek, Portuguese, Polish, Czech, Hungarian, Spanish). 'Pregnant Partner' information forms are included for multiple countries. No explicit text on assent procedures for minors or detailed consent/assent workflows is provided in the CTIS data.

Geography

Total Number Of Sites
95
Total Number Of Participants
370

Austria

Earliest CTIS Part Ii Submission Date
13-02-2026
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
7
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
OncologyHematology – Immunology
Contact Person Name
Sonja Heibl
Contact Person Email
sonja.heibl@klinikumwegr.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Medical Oncology and Hematology
Contact Person Name
Clemens Dormann
Site Name
Universitaetsklinikum Krems
Department Name
Division of Internal Medicine 2
Contact Person Name
Josef Singer
Contact Person Email
Josef.singer@krems.lknoe.at
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
3 rd Medical Dpt. with Hematology, Med. Oncology, Hemostaseolog y, Infect. Disease and Rheumatology
Contact Person Name
Simon Peter Gampenrieder
Contact Person Email
s.gampenrieder@salk.at
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Department of Medicine I, Center for Oncology and Hematology
Contact Person Name
Simon Udovica

France

Earliest CTIS Part Ii Submission Date
07-01-2026
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
41
Number Of Sites
12
Number Of Participants
35

Sites

Site Name
Institut Paoli Calmettes
Department Name
Medical Oncology
Contact Person Name
Alexandre Tassin de Nonneville
Site Name
CHU Besancon
Department Name
Medical Oncology
Contact Person Name
Laura Mansi
Contact Person Email
lmansi@chu-besancon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Medical Oncology
Contact Person Name
Eurydice Angeli
Contact Person Email
eurydice.angeli@aph.fr
Site Name
Centre De Cancerologue Du Grand Montpellier
Department Name
Medical Oncology
Contact Person Name
Cristian Villanueva
Contact Person Email
villanueva@ccgm.fr
Site Name
Oncopole Claudius Regaud
Department Name
Medical Oncology
Contact Person Name
Florence Dalenc
Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Contact Person Name
Barbara Pistilli
Site Name
Hospital Femme Mere Enfant
Department Name
Medical Oncology
Contact Person Name
Julien Peron
Contact Person Email
Julien.peron@chu-lyon.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Medical Oncology
Contact Person Name
Elise Deluche
Contact Person Email
elise.deluche@chu-limoges.fr
Site Name
Hopital Prive Des Cotes D'armor
Department Name
Medical Oncology
Contact Person Name
Jérôme Martin-Babau
Contact Person Email
j.martin@cario-sante.fr
Site Name
Hospices Civils De Lyon
Department Name
Medical Oncology
Contact Person Name
Julien Peron
Contact Person Email
Julien.peron@chu-lyon.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Medical Oncology
Contact Person Name
Lucie Monceau-Baroux
Site Name
Hopital De La Croix-Rousse
Department Name
Medical Oncology
Contact Person Name
Julien Peron
Contact Person Email
Julien.peron@chu-lyon.fr

Germany

Earliest CTIS Part Ii Submission Date
12-01-2026
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
38
Number Of Sites
7
Number Of Participants
49

Sites

Site Name
Goethe University Frankfurt
Department Name
Klinik für Frauenheilkunde und Geburtshilfe, Onkologische Studien
Contact Person Name
Christine Solbach
Contact Person Email
solbach@med.uni-frankfurt.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Frauenklinik mit Poliklinik
Contact Person Name
Peter Fasching
Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
Landesfrauenklinik
Contact Person Name
Vesna Bjelic-Radisic
Site Name
MVZ Medical Center Duesseldorf GmbH
Department Name
Zentrum für Gynäkologische Onkologie
Contact Person Name
Athina Kostara
Site Name
Klinikum Worms gGmbH
Department Name
Frauenklinik
Contact Person Name
Matthias Koegel
Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
Klinik für Gynäkologie undGeburtshilfe
Contact Person Name
Marco Thill
Contact Person Email
marc.thill@agaplesion.de
Site Name
Kreiskrankenhaus Torgau Johann Kentmann gGmbH
Department Name
Kreiskrankenhaus Torgau Johann Kentmann gGmbH
Contact Person Name
Eike Simon
Contact Person Email
simon@kkh-torgau.de

Romania

Earliest CTIS Part Ii Submission Date
31-10-2025
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
115
Number Of Sites
7
Number Of Participants
24

Sites

Site Name
Oncomed S.R.L.
Department Name
Department of Medical Oncology
Contact Person Name
Daniela Elvira Sirbu
Contact Person Email
valeriu.boruga@oncohelp.ro
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Department of Medical Oncology
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Department of Medical Oncology
Contact Person Name
Simona Ruxandra Volovat
Contact Person Email
Simona_v2002@yahoo.com
Site Name
Ovidius Clinical Hospital S.R.L.
Department Name
Department of Medical Oncology
Contact Person Name
Laura Mazilu
Contact Person Email
office@ovidius-ch.ro
Site Name
Spitalul Clinic Filantropia
Department Name
Department of Medical Oncology
Contact Person Name
Mircea Dragos Median
Contact Person Email
office@spitalulfilantropia.ro
Site Name
Medisprof S.R.L.
Department Name
Department of Medical Oncology
Contact Person Name
Adrian Anghel Udrea
Contact Person Email
adrianudrea@medisprof.ro
Site Name
Medisprof S.R.L. (Cluj-Napoca site)
Department Name
Department of Medical Oncology
Contact Person Name
Adrian Anghel Udrea
Contact Person Email
adrianudrea@medisprof.ro

Italy

Earliest CTIS Part Ii Submission Date
29-01-2026
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
99
Number Of Sites
14
Number Of Participants
49

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Oncology Division
Contact Person Name
Michelino De Laurentiis
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Oncologia Medica 1-Universitaria
Contact Person Name
Carmelo Bengala
Site Name
IRCCS Azienda Ospedaliera Metropolitana
Department Name
Oncologia Medica
Contact Person Name
Lucia Del Mastro
Contact Person Email
lucia.delmastro@aomliguria.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Oncologia
Contact Person Name
Alberto Zambelli
Contact Person Email
azambelli@asst-pg23.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia Medica
Contact Person Name
Giampaolo Bianchini
Contact Person Email
giampaolo.bianchini@hsr.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Senologia Medica
Contact Person Name
Marco Colleoni
Contact Person Email
marco.colleoni@ieo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Scienze della salute della donna del bambino e di sanità pubblica
Contact Person Name
Alessandra Fabi
Site Name
Azienda USL Toscana Centro
Department Name
SOC Oncologia Medica
Contact Person Name
Laura Biganzoli
Site Name
Humanitas Mirasole S.p.A.
Department Name
Oncologia Medica
Contact Person Name
Carmen Criscitiello
Contact Person Email
carmen.criscitiello@hunimed.eu
Site Name
Ospedale Vito Fazzi Lecce
Department Name
Oncologia Universitaria
Contact Person Name
Ugo Federico Francesco De Giorgi
Contact Person Email
ugo.degiorgi@unisalento.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name
Oncologia medica ed ematologia
Contact Person Name
Claudio Zamagni
Contact Person Email
claudio.zamagni@aosp.bo.it
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia 2
Contact Person Name
Valentina Guarneri
Contact Person Email
valentina.guarneri@unipd.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Research Unit Phase I Trials
Contact Person Name
Marina Elena Cazzaniga
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
SOC Oncologia medica e prevenzione oncologica
Contact Person Name
Fabio Puglisi
Contact Person Email
fabio.puglisi@cro.it

Netherlands

Earliest CTIS Part Ii Submission Date
11-02-2026
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
86
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Gelre Hospitals
Department Name
Oncologist
Contact Person Name
S.C.S. Tromp-van Driel
Contact Person Email
research_interne@gelre.nl
Site Name
Amsterdam UMC Stichting
Department Name
Oncologist
Contact Person Name
Inge Konings
Contact Person Email
i.konings@amsterdamumc.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Oncologist
Contact Person Name
Maaike de Boer
Contact Person Email
maaike.de.boer@mumc.nl

Greece

Earliest CTIS Part Ii Submission Date
31-10-2025
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
180
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
General University Hospital Of Patras
Department Name
Division of Oncology, Department of Medicine
Contact Person Name
Angelos Koutras
Contact Person Email
angkoutr@otenet.gr
Site Name
Athens Medical Center S.A.
Department Name
3rd Department of Oncology
Contact Person Name
Konstantinos Papazisis
Contact Person Email
k.papazisis@oncomedicare.com
Site Name
Areteio Hospital
Department Name
B’ Surgery Clinic, Oncology Unit
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
Metropolitan Hospital
Department Name
1st Oncology Clinic
Contact Person Name
Dimitrios Bafaloukos

Portugal

Earliest CTIS Part Ii Submission Date
04-12-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
141
Number Of Sites
5
Number Of Participants
22

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Medical Oncology
Contact Person Name
Sara Alves
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Oncology
Contact Person Name
Alexandra Mesquita
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Medical Oncology
Contact Person Name
Hugo Nunes
Contact Person Email
hnunes@ipolisboa.min-saude.pt
Site Name
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
Department Name
Medical Oncology
Contact Person Name
Diana Martins
Contact Person Email
dmmmartins@chtmad.min-saude.pt
Site Name
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Department Name
Medical Oncology
Contact Person Name
António Pêgo
Contact Person Email
3037@ipocoimbra.min-saude.pt

Poland

Earliest CTIS Part Ii Submission Date
09-02-2026
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
87
Number Of Sites
9
Number Of Participants
41

Sites

Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Elżbieta Senkus-Konefka
Contact Person Email
elsenkus@gumed.edu.pl
Site Name
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Department Name
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina Oddział Onkologii Klinicznej
Contact Person Name
Cezary Szczylik
Site Name
Mruk-Med I Sp. z o.o.
Contact Person Name
Andrzej Mruk
Site Name
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name
SS im. Rydygiera w Krakowie Oddz.Onkologii Klinicznej z Pododdziałem Dziennym
Contact Person Name
Anna Kowalczyk-Tekiela
Site Name
Centrum Medyczne Medyk Sp. z o.o. S.K.
Department Name
Szpital Centrum Medycznego Medyk
Contact Person Name
Kamil Kuć
Site Name
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Department Name
Mazowiecki Szpital Onkologiczny Poradnia Onkologiczna
Contact Person Name
Michał Kunkiel
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Poradnia Chemioterapii
Contact Person Name
Aleksandra Łacko
Contact Person Email
aleksandra.lacko@dcopih.pl
Site Name
Instytut Msf Sp. z o.o.
Department Name
Instytut MSF
Contact Person Name
Ewa Kalinka
Contact Person Email
imsf.clinicaltrials@gmail.com
Site Name
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Department Name
Oddział Dzienny Chemioterapii i Hematologii Onkologicznej
Contact Person Name
Dariusz Sawka
Contact Person Email
cwbk@szpital-brzozow.pl

Czechia

Earliest CTIS Part Ii Submission Date
23-01-2026
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
76
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
Onkologická klinika 2. LF UK a FN Motol a Homolka/Oncology clinic 2nd Faculy of Medicine UK and FHMH
Contact Person Name
Tomáš Büchler
Contact Person Email
tomas.buchler@fnmotol.cz
Site Name
Multiscan s.r.o.
Department Name
Onkologický stacionář/ Oncology outpatient clinic
Contact Person Name
Martin Šmakal
Contact Person Email
msmakal@gmail.com
Site Name
Krajska Nemocnice T Bati a.s.
Department Name
Onkologicka klinika/Oncology clinic
Contact Person Name
Michaela Zábojníková
Contact Person Email
zabojnikova@bnzlin.cz
Site Name
Krajska nemocnice Liberec a.s.
Department Name
Onkologicka klinika/Oncology clinic
Contact Person Name
Marek Sochor
Contact Person Email
Marek.sochor@nemlib.cz
Site Name
University Hospital Olomouc
Department Name
Onkologicka klinika/Oncology clinic
Contact Person Name
Bohuslav Melichar
Contact Person Email
Bohuslav.melichar@fnol.cz

Hungary

Earliest CTIS Part Ii Submission Date
16-12-2025
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
132
Number Of Sites
4
Number Of Participants
22

Sites

Site Name
Tolna Varmegyei Balassa Janos Korhaz
Department Name
Oncology
Contact Person Name
Yousuf AL-Farhat
Contact Person Email
yalfarhat@gmail.com
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Department of Radiooncology
Contact Person Name
Andras Szigeti
Contact Person Email
drszigetia@gmail.com
Site Name
University Of Debrecen
Department Name
Oncology Clinic
Contact Person Name
Péter Árkosy
Contact Person Email
arkosy.peter@med.unideb.hu
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Oncoradiology Center
Contact Person Name
Judit Kocsis
Contact Person Email
kocsisjucidr@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
22-01-2026
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
104
Number Of Sites
15
Number Of Participants
49

Sites

Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Yann Izarzugaza Peron
Contact Person Email
YIzarzugaza@quironsalud.es
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Montserrat Muñoz Mateu
Contact Person Email
mmunoz@clinic.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Meritxell Bellet Ezquerra
Contact Person Email
mbellet@vhio.net
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Oncology
Contact Person Name
Jose Luis Alonso Romero
Contact Person Email
josel.alonso2@carm.es
Site Name
Hospital Universitario De Leon
Department Name
Oncology
Contact Person Name
Ana López González
Contact Person Email
alopezgo@saludcastillayleon.es
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Oncology
Contact Person Name
Jose Juan Ponce Lorenzo
Contact Person Email
oncologia@isabial.es
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncology
Contact Person Name
Raquel Andres Conejero
Contact Person Email
randresc@salud.aragon.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Begoña Bermejo De Las Heras
Contact Person Email
begobermejo@gmail.com
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Eva Maria Ciruelos Gil
Contact Person Email
eva.ciruelos@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
Luis De la Cruz Merino
Contact Person Email
ldelacruzmerino@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Contact Person Name
Virginia Martinez Marin
Contact Person Email
vmartinezm@salud.madrid.org
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Oncology
Contact Person Name
Maria Isabel Blancas Lopez-Barajas
Contact Person Email
isabelblancas@hotmail.com
Site Name
Hospital Beata Maria Ana
Department Name
Oncology
Contact Person Name
Javier Cortes Castan
Contact Person Email
javier.cortes@maj3.health
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology
Contact Person Name
José Manuel Perez Garcia
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Oncology
Contact Person Name
Serafin Morales Murillo
Contact Person Email
serafinmorales01@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
04-02-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
82
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
UZ Brussel
Department Name
Medical Oncology
Contact Person Name
Christel Fontaine
Contact Person Email
christel.fontaine@uzbrussel.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Contact Person Name
François Duhoux
Contact Person Email
francois.duhoux@uclouvain.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Medical Oncology
Contact Person Name
Laure Nuytemans
Contact Person Email
laure.nuytemans@azgroeninge.be
Site Name
CHC MontLegia
Department Name
Medical Oncology
Contact Person Name
Marie Scheen
Contact Person Email
marie.scheen@chc.be
Site Name
Grand Hopital De Charleroi
Department Name
Hemato - Oncology
Contact Person Name
Sarah Lefèvre
Contact Person Email
sarah.lefevre@ghdc.be

Sponsor

Primary sponsor

Full Name
Olema Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
CRO (sponsorDuties code 15)
Name
PRA Hellas CRO A.E.
Responsibilities
CRO (sponsorDuties code 15)

Third parties

  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"[{\"id\":990630,\"code\":\"11\"},{\"id\":990631,\"code\":\"13\"},{\"id\":990632,\"code\":\"8\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"[{\"id\":990627,\"code\":\"15\",\"value\":\"CRO\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Edetek Inc.","duties_or_roles":"[{\"id\":990634,\"code\":\"6\"},{\"id\":990635,\"code\":\"7\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"[{\"id\":990636,\"code\":\"3\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"[{\"id\":990629,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"[{\"id\":990633,\"code\":\"15\",\"value\":\"CRO\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"[{\"id\":990628,\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Palazestrant
Active Substance
OP-1250 / PALAZESTRANT
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus 1
Maximum Dose
90.00 mg (maxDailyDoseAmount)
Investigational Product Name
RIBOCICLIB
Active Substance
RIBOCICLIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus 2
Maximum Dose
600.00 mg (maxDailyDoseAmount)
Investigational Product Name
LETROZOLE
Active Substance
LETROZOLE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus 2
Maximum Dose
2.50 mg (maxDailyDoseAmount)
Investigational Product Name
GnRH (LHRH) agonist
Active Substance
-
Modality
Peptide/protein/enzyme
Routes Of Administration
IMPLANTATION
Route
IMPLANTATION
Authorisation Status
prodAuthStatus 2 (listed under ATC L02AE)
Maximum Dose
3.60 mg (maxDailyDoseAmount)
Combination Treatment
Yes

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