Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,028
Countries
13
Sites
101
ER+, HER2- Advanced Breast Cancer
To compare PFS, based on a Local Investigator assessment between investigational (palazestrant with ribociclib + letrozole-matching placebo) and control (letrozole with ribociclib + palazestrant-matching placebo) arms.
Key facts
- Sponsor
- Olema Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Feb 2026 → ongoing
- Decision date (initial)
- 2026-02-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Olema Pharmaceuticals, Inc.
External identifiers
- EU CT number
- 2025-522873-12-00
- ClinicalTrials.gov
- NCT07085767
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Pharmacogenetic, Safety, Efficacy
To compare PFS, based on a Local Investigator assessment between investigational (palazestrant with ribociclib + letrozole-matching placebo) and control (letrozole with ribociclib + palazestrant-matching placebo) arms.
Secondary objectives 7
- 1. To compare OS between investigational and control arms.
- 2. To evaluate PFS, ORR, DOR and CBR based on Blinded Independent Review Committee (BIRC) assessment.
- 3. To evaluate ORR, DOR, CBR based on Local Investigator assessment
- 4. To evaluate safety and tolerability
- 5. To evaluate the PK of palazestrant and ribociclib
- 6. To evaluate the change from baseline in healthrelated PROs
- 7. To evaluate PFS2
Conditions and MedDRA coding
ER+, HER2- Advanced Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10027475 | Metastatic breast cancer | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 1. Adult female or male participants.
- 2. ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
- 3. Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).
- 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)
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 6. Adequate hematologic, hepatic, and renal functions.
- 7. Female participants can be pre-, peri- or postmenopausal.
- 8. Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.
Exclusion criteria 6
- 1. Disease recurrence during adjuvant endocrine therapy
- 2. Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.
- 3. Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.
- 4. History of allergic reactions to study treatment.
- 5. Any contraindications to letrozole and ribociclib.
- 6. Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Local Investigator-assessed PFS (Progression-Free Survival)
Secondary endpoints 7
- 1. OS
- 2. BIRC-assessed PFS, ORR, DOR and CBR
- 3. Local Investigator-assessed ORR, DOR, CBR
- 4. Safety and tolerability, assessed by AEs, SAEs, dose modifications, clinical laboratory parameters, ECGs, performance status, and vital sign measurements
- 5. Plasma levels of palazestrant and ribociclib (in investigational arm) and of ribociclib (in control arm) at predefined intervals to establish PK parameters.
- 6. PRO endpoints, assessed using the EORTC QLQ- C30, EORTC QLQ-BR42 and EQ-5D-5L questionnaires
- 7. Time from randomization to disease progression on first subsequent systemic anti-cancer therapy or death
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD10738348 · Product
- Active substance
- OP-1250
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 90.0 mg milligram(s)
- Max total dose
- 9999.00 mg milligram(s)
- Max treatment duration
- 9999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- OLEMA PHARMACEUTICALS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11726239 · Product
- Active substance
- Palazestrant
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 90.00 mg milligram(s)
- Max total dose
- 9999.00 mg milligram(s)
- Max treatment duration
- 9999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- OLEMA PHARMACEUTICALS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10738349 · Product
- Active substance
- OP-1250
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 90.00 mg milligram(s)
- Max total dose
- 9999.00 mg milligram(s)
- Max treatment duration
- 9999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- OLEMA PHARMACEUTICALS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
SUB180246 · Substance
- Active substance
- Ribociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600.00 mg milligram(s)
- Max total dose
- 9999.00 mg milligram(s)
- Max treatment duration
- 9999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clinical batches of Ribociclib 200 mg film-coated tablet are manufactured at the approved commercial site of drug product manufacture using commercial drug substance. In addition to the approved sites in the MAA, additional sites are used to package and control the clinical product. The shelf-life of the clinical product is longer, based on acceptable stability.
Comparator 1
SCP1154118 · ATC
- Active substance
- Letrozole
- Route of administration
- ORAL
- Max daily dose
- 2.50 mg milligram(s)
- Max total dose
- 9999.00 mg milligram(s)
- Max treatment duration
- 9999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- For blinding purposes, the commercial product letrozole tablet is over-encapsulated.
Placebo 1
Palazestrant matching placebo tablets and Letrozole matching placebo capsules
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 1
-
L02AE · Product
- Pharmaceutical form
- PHF00243MIG
- Route of administration
- IMPLANTATION
- Max daily dose
- 3.60 mg milligram(s)
- Max total dose
- 9999.00 mg milligram(s)
- Max treatment duration
- 9999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02AE — GONADOTROPIN RELEASING HORMONE ANALOGUES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labelling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Olema Pharmaceuticals Inc.
- Sponsor organisation
- Olema Pharmaceuticals Inc.
- Address
- 780 Brannan Street
- City
- San Francisco
- Postcode
- 94103-4919
- Country
- United States
Scientific contact point
- Organisation
- Olema Pharmaceuticals Inc.
- Contact name
- Olema Pharmaceuticals
Public contact point
- Organisation
- Olema Pharmaceuticals Inc.
- Contact name
- Olema Pharmaceuticals
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| PPD Development LP ORG-100011560
|
Wilmington, United States | Code 11, Code 13, Code 8 |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Edetek Inc. ORG-100045957
|
Princeton, United States | Data management, E-data capture |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| PRA Hellas CRO A.E. ORG-100048208
|
Nea Ionia, Greece | Other |
| Fisher Clinical Services GmbH ORG-100017323
|
Weil Am Rhein, Germany | Code 14 |
Locations
13 EU/EEA countries · 101 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 16 | 5 |
| Belgium | Ongoing, recruiting | 20 | 5 |
| Czechia | Ongoing, recruiting | 15 | 5 |
| France | Ongoing, recruiting | 35 | 12 |
| Germany | Authorised, recruiting | 63 | 14 |
| Greece | Ongoing, recruiting | 15 | 4 |
| Hungary | Ongoing, recruiting | 22 | 4 |
| Italy | Ongoing, recruiting | 49 | 14 |
| Netherlands | Ongoing, recruiting | 13 | 3 |
| Poland | Ongoing, recruiting | 41 | 9 |
| Portugal | Authorised, recruiting | 22 | 5 |
| Romania | Ongoing, recruiting | 24 | 6 |
| Spain | Ongoing, recruiting | 49 | 15 |
| Rest of world
Brazil, Thailand, Canada, Korea, Republic of, Taiwan, Mexico, Argentina, United States, Chile, Malaysia, United Kingdom, Hong Kong, Philippines, Australia, Israel
|
— | 644 | — |
Investigational sites
Klinikum Wels-Grieskirchen GmbH
OncologyHematology – Immunology, Grieskirchner Strasse 42, 4600, Wels
Stadt Wien Wiener Gesundheitsverbund
Department of Medicine I, Center for Oncology and Hematology, Montleartstrasse 37, Ottakring, Vienna
Universitaetsklinikum Krems
Division of Internal Medicine 2, Mitterweg 10, 3500, Krems An Der Donau
Ordensklinikum Linz GmbH
Medical Oncology and Hematology, Seilerstaette 4, 4010, Linz
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
3 rd Medical Dpt. with Hematology, Med. Oncology, Hemostaseolog y, Infect. Disease and Rheumatology, Muellner Hauptstrasse 48, 5020, Salzburg
Grand Hopital De Charleroi
Hemato - Oncology, Rue Du Campus Des Viviers 1, 6060, Charleroi
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Algemeen Ziekenhuis Groeninge
Medical Oncology, President Kennedylaan 4, 8500, Kortrijk
UZ Brussel
Medical Oncology, Laarbeeklaan 101, 1090, Jette
CHC MontLegia
Medical Oncology, Boulev. De Patience Et Beajonc 2, 4000, Liege
Krajska Nemocnice T Bati a.s.
Onkologicka klinika/Oncology clinic, Havlickovo Nabrezi 600, 760 01, Zlin
University Hospital Olomouc
Onkologicka klinika/Oncology clinic, Zdravotniku 248/7, 779 00, Olomouc
Krajska nemocnice Liberec a.s.
nkologicka klinika/Oncology clinic, Husova 1430/34, 460 01, Liberec I-Stare Mesto
Multiscan s.r.o.
Onkologický stacionář/ Oncology outpatient clinic, K Nemocnici 1106, 268 31, Horovice
Fakultni Nemocnice Motol A Homolka
Onkologická klinika 2. LF UK a FN Motol a Homolka/Oncology clinic 2nd Faculy of Medicine UK and FHMH, V Uvalu 84/1, Motol, Prague
Institut Paoli Calmettes
Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
CHU Besancon
Medical Oncology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Assistance Publique Hopitaux De Paris
Medical Oncology, 125 Rue De Stalingrad, 93000, Bobigny
Centre De Cancerologue Du Grand Montpellier
Medical Oncology, 25 Rue De Clementville, 34070, Montpellier
Oncopole Claudius Regaud
Medical Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Hospital Femme Mere Enfant
Medical Oncology, 52 Boulevard Pinel, 69500, Bron
Centre Hospitalier Et Universitaire De Limoges
Medical Oncology, 2 Avenue Martin Luther King, 87000, Limoges
Hopital Prive Des Cotes D'armor
Medical Oncology, 10 Rue Francois Jacob, 22190, Plerin
Hospices Civils De Lyon
Medical Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Regional Et Universitaire De Brest
Medical Oncology, Boulevard Tanguy Prigent, 29200, Brest
Hopital De La Croix-Rousse
Medical Oncology, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
DBZ Okologie GmbH
N/A, Studienzentrum Gynäkologische Onkologie in Berlin-Mahlsdorf, Hönower Straße 31-33, Berlin
MVZ Medical Center Duesseldorf GmbH
Zentrum für Gynäkologische Onkologie, Luise-Rainer-Strasse 6-10, Flingern Nord, Duesseldorf
Technische Universitaet Dresden
N/A, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Helios Universitaetsklinikum Wuppertal
Landesfrauenklinik, Heusnerstrasse 40, Barmen, Wuppertal
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Klinik für Gynäkologie undGeburtshilfe, Wilhelm-Epstein-Strasse 4, Bockenheim, Frankfurt Am Main
Goethe University Frankfurt
Klinik für Frauenheilkunde und Geburtshilfe, Onkologische Studien, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Marienhospital Witten
N/A, Marienhospital Witten, Brustzentrum, Witten
LMU Klinikum Muenchen AöR
N/A, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Ulm AöR
N/A, Prittwitzstrasse 43, Mitte, Ulm
National Center For Tumor Diseases (NCT) Heidelberg
N/A, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Medizinisches Versorgungszentrum MediaVita GmbH Muenster
N/A, Hohenzollernring 70, Herz-Jesu, Muenster
Kreiskrankenhaus Torgau Johann Kentmann gGmbH
Kreiskrankenhaus Torgau Johann Kentmann gGmbH, Christianistrasse 1, 04860, Torgau
Universitaetsklinikum Erlangen AöR
Frauenklinik mit Poliklinik, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Klinikum Worms gGmbH
Frauenklinik, Gabriel-Von-Seidl-Strasse 81, Herrnsheim, Worms
Areteio Hospital
B’ Surgery Clinic, Oncology Unit, Vassilissas Sofias Avenue 76, 115 28, Athens
Metropolitan Hospital
1st Oncology Clinic, Ethnarchi Makariou 9, 185 47, Pireas
Athens Medical Center S.A.
3rd Department of Oncology, Pylea, Asklipiou 10, Thessaloniki
General University Hospital Of Patras
Division of Oncology, Department of Medicine, Rio, 265 04, Patras
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department of Radiooncology, Vasvari Pal Utca 2-4, 9024, Gyor
Bacs-Kiskun Varmegyei Oktatokorhaz
Oncoradiology Center, Nyiri Ut 38, 6000, Kecskemet
Tolna Varmegyei Balassa Janos Korhaz
Oncology, Beri Balogh Adam Utca 5-7, 7100, Szekszard
University Of Debrecen
Oncology Clinic, Nagyerdei Korut 98, 4032, Debrecen
Azienda USL Toscana Centro
SOC Oncologia Medica, Via Suor Niccolina Infermiera 20/22, 59100, Prato
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Oncologia, Piazza Oms 1, 24127, Bergamo
Humanitas Mirasole S.p.A.
Oncologia Medica, Via Alessandro Manzoni 56, 20089, Rozzano
Ospedale Vito Fazzi Lecce
Oncologia Universitaria, Piazza Filippo Muratore 1, 73100, Lecce
Fondazione IRCCS San Gerardo Dei Tintori
Research Unit Phase I Trials, Via Giovanbattista Pergolesi 33, 20900, Monza
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Scienze della salute della donna del bambino e di sanità pubblica, Largo Francesco Vito 1, 00168, Rome
Centro Di Riferimento Oncologico Di Aviano
SOC Oncologia medica e prevenzione oncologica, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oncologia medica ed ematologia, Via Pietro Albertoni 15, 40138, Bologna
Ospedale San Raffaele S.r.l.
Oncologia Medica, Via Olgettina 60, 20132, Milan
Istituto Europeo Di Oncologia S.r.l.
Senologia Medica, Via Giuseppe Ripamonti 435, 20141, Milan
Istituto Oncologico Veneto
UOC Oncologia 2, Via Gattamelata 64, 35128, Padova
IRCCS Azienda Ospedaliera Metropolitana
Oncologia Medica, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Ospedaliero Universitaria Pisana
UO Oncologia Medica 1-Universitaria, Via Roma 67, 56126, Pisa
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncology Division, Via Mariano Semmola 52, 80131, Naples
Amsterdam UMC Stichting
Oncologist, De Boelelaan 1117, 1081 HV, Amsterdam
Gelre Hospitals
Oncologist, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
Academisch Ziekenhuis Maastricht
Oncologist, P Debyelaan 25, 6229 HX, Maastricht
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii ul. Mariana Smoluchowskiego 17 80-214 Gdańsk, Ul. Debinki 7, 80-952, Gdansk
Mruk-Med I Sp. z o.o.
N/A, Ul. Gen. Mariana Langiewicza 61, 35-021, Rzeszow
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
SS im. Rydygiera w Krakowie Oddz.Onkologii Klinicznej z Pododdziałem Dziennym, Os. Zlotej Jesieni 1, 31-826, Cracow
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Poradnia Chemioterapii, Pl. Ludwika Hirszfelda 12, 53-413, Wroclaw
Instytut Msf Sp. z o.o.
Instytut MSF, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz
Centrum Medyczne Medyk Sp. z o.o. S.K.
Szpital Centrum Medycznego Medyk, Al. Tadeusza Rejtana 53, 35-326, Rzeszow
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina Oddział Onkologii Klinicznej, Ul. Borowa 14/18, 05-400, Otwock
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Mazowiecki Szpital Onkologiczny Poradnia Onkologiczna, Al. Solidarnosci 12, 03-411, Warsaw
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Oddział Dzienny Chemioterapii i Hematologii Onkologicznej, Ul. Ks. Jozefa Bielawskiego 18, 36-200, Brzozow
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
Medical Oncology, Ulstmad, Avenida Da Noruega, Vila Real
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Medical Oncology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Unidade Local De Saude De Matosinhos E.P.E.
Oncology, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Medical Oncology, Avenida Doutor Bissaya Barreto 98, 3000-075, Coimbra
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Medical Oncology, Rua Professor Lima Basto, 1099-023, Lisbon
Centrul De Oncologie SF Nectarie S.R.L.
Department of Medical Oncology, Strada Caracal Nr 109, 200542, Craiova
Oncomed S.R.L.
Department of Medical Oncology, Strada Porumbescu Ciprian 57-59, 300239, Timisoara
Ovidius Clinical Hospital S.R.L.
Department of Medical Oncology, Dn 2a Km 202 880, 905900, Ovidiu
Medisprof S.R.L.
Department of Medical Oncology, Bulevardul Muncii 96, 400641, Cluj-Napoca
Centrul De Oncologie-Euroclinic S.R.L.
Department of Medical Oncology, Strada Conta Vasile 2, 700106, Iasi
Spitalul Clinic Filantropia
Department of Medical Oncology, Bulevardul Mihalache Ion 11-13, 011171, Bucharest
Hospital Beata Maria Ana
Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
University Clinical Hospital Virgen De La Arrixaca
Oncology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital General Universitario Dr. Balmis
Oncology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Clinico Universitario Lozano Blesa
Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario De Leon
Oncology, Calle Altos De Nava S/n, 24071, Leon
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Oncology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Hospital Universitario La Paz
Oncology, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Clinico San Cecilio
Oncology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2026-05-05 | 2026-05-20 | |||
| Belgium | 2026-04-28 | 2026-06-01 | |||
| Czechia | 2026-04-24 | 2026-04-29 | |||
| France | 2026-03-24 | 2026-04-23 | |||
| Germany | 2026-04-22 | ||||
| Greece | 2026-03-24 | 2026-04-30 | |||
| Hungary | 2026-04-28 | 2026-05-04 | |||
| Italy | 2026-03-20 | 2026-04-21 | |||
| Netherlands | 2026-02-24 | 2026-04-21 | |||
| Poland | 2026-03-26 | 2026-05-05 | |||
| Portugal | 2026-04-29 | ||||
| Romania | 2026-03-20 | 2026-04-06 | |||
| Spain | 2026-03-13 | 2026-03-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 121 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-522873-12-00_Greek_redacted | 2.2 |
| Protocol (for publication) | D1_Protocol_2025-522873-12-00_redacted | 2.3 |
| Recruitment arrangements (for publication) | K_HU_Recruitment Arrangements_Placeholder document | N/A |
| Recruitment arrangements (for publication) | K1_AT_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_BE_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_CZ_Recruitment Procedure_Bilingual | 1.0 |
| Recruitment arrangements (for publication) | K1_DE_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_EL_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_ES_Recruitment Procedure | N/A |
| Recruitment arrangements (for publication) | K1_FR_Recruitment Procedure_Bilingual | 1.1 |
| Recruitment arrangements (for publication) | K1_IT_Recruitment Procedure | N/A |
| Recruitment arrangements (for publication) | K1_NL_Recruitment Procedure | 1.2 |
| Recruitment arrangements (for publication) | K1_PL_Recruitment Arrangements_Polish | N/A |
| Recruitment arrangements (for publication) | K1_PT_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_RO_Recruitment Procedure | N/A |
| Recruitment arrangements (for publication) | P1_FR_Recruitment arrangements_Additional document_French_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Contact Person_German | 1.1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Main_German_redacted | 2.3 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Pregnant Partner_German | 1.3 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_site info_Placeholder document | N/A |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Greenphire DPN_Dutch | 1.3 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Greenphire DPN_French | 1.3 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_Dutch_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_French_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_Sponsor Statement_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnant Partner_Dutch_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnant Partner_French_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Future Research_Czech | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Greenphire Data Protection Notice_Czech | 1.2 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Main_Czech | 4.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Pregnant Partner_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Privacy ICF_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Main_German_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Optional Future Research_German | 2.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Pregnant Partner_Participant_German | 2.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Data Protection Notice_Greek_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Main_Greek_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Pregnant Partner_Greek | 1.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main_Spanish_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnant Partner_Spanish | 1.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Future Research_French | 3.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Greenphire_French | 1.2 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main_French_redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Pregnancy_French | 3.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_SCOUT_French | 1.0 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Data protection_Greenphire_Hungarian | 1.2 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Genetic_Hungarian | 2.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS_Future Research_Hungarian | 2.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS_Genetic_Hungarian | 2.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Future Research_Hungarian | 3.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Main_Hungarian_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Pregnant Partner_Hungarian | 2.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Adult_Italian_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Future Research_Italian | 1.1 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Greenphire Data Protection Notice_Italian | 1.2 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Pregnancy_Italian | 1.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Privacy_Italian | 2.1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Main_Dutch_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Pregnancy_Dutch | 1.2 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Main_Polish_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnant Partner_Polish | 1.2 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Future Use_Portuguese | 2.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Genetic Testing_Portuguese | 2.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Main_Portuguese_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Pregnancy_Portuguese | 2.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_Romanian_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnant Partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnant Partner_Romanian | 1.0 |
| Subject information and informed consent form (for publication) | L2_AT_Other Subject Material_Greenphire privacy notice with consent_German | 1.2 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_Bank Transfer FAQ_Czech | 10.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_Bank Transfer Standard Message Template_Czech | 10.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_ClinCard Cardholder Message Template_Czech | 10.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_ConneX Travel Contact Card_Czech | 10.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_ConneX Travel Reference Guide for Participants_IC_Czech | 10.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_Dosing Instruction Card_Czech | 2.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_Greenphire LLC Privacy Policy_Czech | 11.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_GreenSpace Account Information Change_Czech | 10.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_GreenSpace Participant Email Template_Czech | 10.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_GreenSpace Participant FAQ Bank Transfer 1_Czech | 11.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_GreenSpace Participant FAQ Bank Transfer_Czech | 10.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_GreenSpace Participant FAQ Cardholder 1_Czech | 11.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_GreenSpace Participant FAQ Cardholder_Czech | 10.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_GreenSpace Participant Forgot Password Email_Czech | 10.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_Greenspace Terms of Use_Czech | 10.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_Patient Card_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_Suvoda Product Terms of Use Privacy Policy_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L2_FR_SIS-ICF_Greenphire Reimbursement Form_French | 1.0 |
| Subject information and informed consent form (for publication) | L2_FR_SIS-ICF_Greenphire Travel Policy_French | 1.0 |
| Subject information and informed consent form (for publication) | L2_FR_SIS-ICF_Greenphire Welcome Letter_French | 1.0 |
| Subject information and informed consent form (for publication) | L2_FR_SIS-ICF_SCOUT Brochure_French | 1.0 |
| Subject information and informed consent form (for publication) | L2_FR_SIS-ICF_SCOUT Email Communication_French | 1.0 |
| Subject information and informed consent form (for publication) | L2_FR_SIS-ICF_SCOUT Reimbursement Form_French | 6.0 |
| Subject information and informed consent form (for publication) | L2_HU_Other subject material_Patient Emergency Card_Hungarian | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Kisqali | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Lametta-Letrozole | N/A |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522873-12-00 | 2.2 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522873-12-00_Czech | 2.2 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522873-12-00_Dutch | 2.2 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522873-12-00_Dutch-BE | 2.2 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522873-12-00_French | 2.2 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522873-12-00_French-BE | 2.2 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522873-12-00_German-BE | 2.2 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522873-12-00_Greek | 2.2 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522873-12-00_Hungarian | 2.2 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522873-12-00_Italian | 2.2 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522873-12-00_Polish | 2.2 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522873-12-00_Portuguese | 2.2 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522873-12-00_Romanian | 2.2 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522873-12-00_Spanish | 2.2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522873-12-00_Czech_redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522873-12-00_Dutch_redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522873-12-00_French_redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522873-12-00_German_redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522873-12-00_Greek_redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522873-12-00_Hungarian_redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522873-12-00_Italian_redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522873-12-00_Polish_redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522873-12-00_Portuguese_redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522873-12-00_Romanian_redacted | 2.2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522873-12-00_Spanish_redacted | 2.2 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-10 | Italy | Acceptable 2026-02-16
|
2026-02-17 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-25 | Italy | Acceptable 2026-02-16
|
2026-02-25 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-27 | Italy | Acceptable 2026-02-16
|
2026-02-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-27 | Italy | Acceptable | 2026-05-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-27 | Acceptable | 2026-05-21 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-31 | Acceptable | 2026-04-29 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-31 | Acceptable | 2026-04-24 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-31 | Acceptable | 2026-05-07 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-31 | Acceptable | 2026-04-09 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-03-31 | Acceptable | 2026-04-27 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-04-01 | Acceptable | 2026-05-08 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-04-01 | Acceptable | 2026-05-06 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-13 | 2026-04-08 | Acceptable | 2026-04-27 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-12 | 2026-04-15 | Acceptable | 2026-05-27 |