Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
908
Countries
6
Sites
90
Neoplasm Metastasis
The purpose of the study is to assess the efficacy and safety of the addition of LY4064809 to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helpi…
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-03-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-522791-92-00
- WHO UTN
- U1111-1329-9086
- ClinicalTrials.gov
- NCT07174336
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Therapy, Pharmacodynamic, Efficacy, Pharmacogenomic, Dose response, Others, Safety
The purpose of the study is to assess the efficacy and safety of the addition of LY4064809 to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.
Conditions and MedDRA coding
Neoplasm Metastasis
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- If assigned female at birth, pre-/peri- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist.
- If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist.
- Have histologically or cytologically confirmed breast cancer
- Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.
- Have measurable disease or non-measurable, evaluable bone disease
- Part 1: Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease. Up to 1 of these prior systemic treatments may contain chemotherapy
- Part 2: Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease. Individuals who are eligible are either Population 1 (P1): Endocrine sensitive newly diagnosed with advanced breast cancer (de novo) relapsed with documented evidence of progression greater than (>)12 months from completion of (neo)adjuvant ET ± cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, or Population 2 (P2): Endocrine resistant relapsed with documented evidence of progression less than or equal to (≤)12 months of completing (neo)adjuvant ET ± CDK4/6 inhibitor. if a CDK4/6 inhibitor was included as part of neoadjuvant or adjuvant therapy, progression event must be >12 months since completion of CDK4/6 inhibitor portion of neoadjuvant or adjuvant therapy.
Exclusion criteria 4
- Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg/dL) (7.7 millimoles per liter [mmol/L]), or requiring insulin.
- Have inflammatory or metaplastic breast cancer.
- History of leptomeningeal disease or carcinomatous meningitis.
- Have known and untreated or active central nervous system (CNS) metastases. Exception: Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of radiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Part 1: Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) [Time Frame: Baseline through disease progression or death (Estimated up to 5 years)] As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
- Part 2: Progression-Free Survival [Time Frame: Baseline to objective progression or death due to any cause (Estimated up to 5 years)] Investigator-assessed
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 12
SCP16235096 · ATC
- Active substance
- Palbociclib
- Substance synonyms
- PD-332,991, PD-0332991
- Route of administration
- ORAL USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 157500 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — PALBOCICLIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP136386 · ATC
- Active substance
- Exemestane
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 42000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG06 — EXEMESTANE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD13062022 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 30500 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
SCP1154118 · ATC
- Active substance
- Letrozole
- Route of administration
- ORAL USE
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 4200 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP25879889 · ATC
- Active substance
- Ribociclib
- Substance synonyms
- LEE011
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 756000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF02 — RIBOCICLIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP136961 · ATC
- Active substance
- Anastrozole
- Route of administration
- ORAL USE
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1680 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG03 — ANASTROZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP15544179 · ATC
- Active substance
- Fulvestrant
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 30500 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BA03 — FULVESTRANT
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD13059215 · Product
- Active substance
- Tersolisib Hemihydrate
- Other product name
- STX-478
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD13059213 · Product
- Active substance
- Tersolisib Hemihydrate
- Other product name
- STX-478
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD13059214 · Product
- Active substance
- Tersolisib Hemihydrate
- Other product name
- STX-478
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD13058253 · Product
- Active substance
- Tersolisib Hemihydrate
- Other product name
- STX-478
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD13058254 · Product
- Active substance
- Tersolisib Hemihydrate
- Other product name
- STX-478
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
to match Tersolisib (LY4064809), STX-478
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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 19
| Organisation | City, country | Duties |
|---|---|---|
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Data management, E-data capture |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Tempus Compass LLC ORG-100052117
|
Chicago, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| The Hibbert Co. ORG-100047639
|
Trenton, United States | Other |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| PPD International Holdings LLC ORG-100007655
|
Zaventem, Belgium | Laboratory analysis |
| Florence Healthcare Inc ORL-000016702
|
Atlanta, United States | Data management |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Pharmaserve Lilly S.A.C.I. ORG-100005347
|
Kifisia, Greece | On site monitoring, Code 12, Other, Code 2, Code 5 |
| Tier 1 Impact Pbc Inc. ORG-100050163
|
Covington, United States | Other |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Icon Clinical Research LLC ORG-100039864
|
Rochester, United States | Laboratory analysis |
| Wuxi Apptec Co. Ltd. ORG-100012470
|
Shanghai, China | Laboratory analysis |
| Pharmaceutical Product Development LLC ORG-100016999
|
Wilmington, United States | Laboratory analysis |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Code 12, Code 2 |
Locations
6 EU/EEA countries · 90 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 25 | 7 |
| France | Authorised, recruitment pending | 41 | 12 |
| Germany | Authorised, recruitment pending | 40 | 21 |
| Greece | Authorised, recruitment pending | 32 | 10 |
| Italy | Authorised, recruitment pending | 36 | 12 |
| Spain | Authorised, recruitment pending | 100 | 28 |
| Rest of world
United States, United Kingdom, Taiwan, Canada, Japan, Korea, Republic of, Argentina, Turkey, Australia, China, Brazil
|
— | 634 | — |
Investigational sites
Institut Jules Bordet
Medical Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Jessa Ziekenhuis
Medical Oncology, Stadsomvaart 11, 3500, Hasselt
UZ Leuven
Gynecologic Oncology, Herestraat 49, 3000, Leuven
Clinique Saint-Pierre
Oncology, Avenue Reine Fabiola 9, 1340, Ottignies-Louvain-La-Neuve
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Oncology, Place Louise Godin 15, 5000, Namur
AZ Nikolaas
Medical Oncology, 5 Lodewijk de Meesterstraat, B-9100, Sint-Niklaas
Algemeen Ziekenhuis Groeninge
Oncology, President Kennedylaan 4, 8500, Kortrijk
Institut Curie - Site Paris
N/A, 26 Rue d'Ulm, Paris, Paris
Clinique Victor Hugo
N/A, Centre De Cancerologie De La Sarthe, 64 Rue De Degre, Le Mans
Institut Curie - Site Saint-Cloud
N/A, 35 Rue Dailly, Saint-Cloud, Saint-Cloud
CHRU de Brest
Institut de cancérologie et d'Hématologie, Bd Tanguy Prigent, Hôpital de la Cavale Blanche, Brest
Institut Jean Godinot
N/A, 1 Rue du Général Koenig, Reims, Reims
Institut Gustave Roussy
N/A, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre De Cancerologue Du Grand Montpellier
N/A, 25 Rue De Clementville, 34070, Montpellier
Hopital Prive Jean Mermoz
Medical Oncology, 55 Avenue Jean Mermoz, 69008, Lyon
Institut De Cancerologie De L Ouest
N/A, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut De Cancerologie De Lorraine
N/A, 6 Avenue De Bourgogne, Cs 30519, Vandoeuvre Les Nancy Cedex
Oncopole Claudius Regaud
N/A, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Sainte Catherine Institut Du Cancer Avignon-Provence
N/A, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Marienhospital Bottrop gGmbH
Frauenklinik, Josef-Albers-Strasse 70, Sued-West-Innenstadt, Bottrop
Staedtisches Klinikum Dessau
Klinik für Frauenheilkunde und Geburtshilfe, Auenweg 38, Alten, Dessau-Rosslau
Medical Center - University Of Freiburg
Klinik für Frauenheilkunde, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
LMU Klinikum Muenchen AöR
N/A, Ziemssenstrasse 1, Ludwigsvorstadt-Isarvorstadt, Munich
Marien Hospital Witten
Brustzentrum, Marienplatz 2, ST. ELISABETH GRUPPE GmbH, Witten
Klinikum Ernst von Bergmann gGmbH
Frauenklinik, Charlottenstrasse 72, Noerdliche Innenstadt, Potsdam
RKH Klinken Ludwigsburg-Bietigheim gGmbH
Klinik für Geburtshilfe und Frauenheilkunde, Posilipostrasse 4, Mitte, Ludwigsburg
Universitaetsklinikum Erlangen AöR
Klinik für Gynäkologie und Geburtshilfe, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Private Practice - Dr. Helmut Oettle und Prof. Dr. med. Frank Mayer
N/A, Friedrichstraße 53, Baden-Württemberg, Friedrichshafen
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Klinik für Frauenheilkunde und Geburtshilfe, Ludwig-Erhard-Strasse 90, Dotzheim, Wiesbaden
Technische Universitaet Dresden
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
N/A, Langenbeckstrasse 1, Oberstadt, Mainz
Charite Universitaetsmedizin Berlin KöR
Klinik Für Gynäkologie Mit Brustzentrum, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Koeln AöR
Klinik und Poliklinik für Frauenheilkunde und Gynäkologische Onkologie, Kerpener Strasse 62, Lindenthal, Cologne
Mammazentrum HH am Krankenhaus Jerusalem
N/A, Moorkamp 2-6, Hamburg, Hamburg
Kliniken Essen-Mitte,Evangelische Huyssens-Stiftung
Klinik für Senologie/ Brustzentrum, Henricistr. 36, Nordrhein-Westfalen, Essen
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Brustzentrum, Wilhelm-Epstein-Strasse 4, Bockenheim, Frankfurt Am Main
Onkologie Donauwoerth (MVZ) GmbH
N/A, Neudegger Allee 10, Neudegger Siedlung, Donauwoerth
Helios Universitaetsklinikum Wuppertal
Senology, Heusnerstrasse 40, Barmen, Wuppertal
MVZ Medical Center Duesseldorf GmbH
GynOnco Düsseldorf - Zentrum für gynäkologische Onkologie, Luise-Rainer-Strasse 6-10, Flingern Nord, Duesseldorf
Universitaetsklinikum des Saarlandes AöR
Klinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin, Kirrberger Strasse 100, 66421, Homburg
General University Hospital Of Larissa
Oncology Department, P. O. Box 1425, 411 10, Larissa
Athens Medical Center S.A.
3rd Department of Oncology, Pylea, Asklipiou 10, Thessaloniki
University General Hospital Of Heraklion
Internal Medicine-Oncology Department, Stavrakia And Voutes, 715 00, Heraklion
University General Hospital Of Ioannina
Oncology Department, Niarchou Stavrou Avenue, 455 00, Ioannina
Areteio Hospital
Oncology Unit, 2nd Surgical Department, Vassilissas Sofias Avenue 76, 115 28, Athens
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Oncology Unit, 2nd Propaedeutic Pathology Clinic, Rimini 1, 124 61, Chaidari
General University Hospital Of Patras
Internal Medicine Clinic-Oncology Department, Rio, 265 04, Patras
Saint Savvas Oncology Hospital
2nd Department of Internal Medicine - Oncology, Alexandras Avenue 171, 115 22, Athens
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
Athens Medical Center S.A.
4th Department of Oncology, Pylea, Asklipiou 10, Thessaloniki
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
UOC Oncologia, Piazza Oms 1, 24127, Bergamo
Humanitas Istituto Clinico Catanese S.p.A.
U.O. Oncologia Medica ed Ematologia, Strada Provinciale 54 Contrada Cubba 11, 95045, Misterbianco
IRCCS Ospedale Policlinico San Martino
UOC Clinica di Oncologia Medica, Largo Rosanna Benzi 10, 16132, Genoa
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Istituto Europeo Di Oncologia S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
IRCCS Azienda Ospedaliero Universitaria - Policlinico di Sant'Orsola
SSD Oncologia Medica Zamagni, Via Albertoni 15, 40138, Bologna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
SCIENZE DELLA SALUTE DELLA DONNA E DEL BAMBINO E DI SANITÀ PUBBLICA, Largo Agostino Gemelli 8, 00168, Rome
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Oncologia Clinica Sperimentale di Senologia, Via Mariano Semmola 52, 80131, Naples
Fondazione IRCCS San Gerardo Dei Tintori
Research Unit Phase 1, Via Giovanbattista Pergolesi 33, 20900, Monza
Azienda Ospedaliera Universitaria Federico II Di Napoli
Oncologia Medica, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero Universitaria Careggi
SOD Radioterapia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Istituto Oncologico Veneto
Oncologia 2, Via Gattamelata 64, 35128, Padova
Hospital Universitario De Canarias
Medical Oncology, Carretera Ofra S/N, 38320, San Cristobal De La Laguna
Hospital Universitario Virgen De La Macarena
Unidad de Investigación Oncológica, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Virgen De La Victoria
Oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Arnau De Vilanova De Valencia
Oncology, Calle De San Clemente 12, 46015, Valencia
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario De Badajoz
Medical Oncology, Avenida Elvas S/n, 06006, Badajoz
Fundacion Instituto Valenciano De Oncologia
Medical Oncology, Calle De Gregorio Gea 3 1 A Planta, 46009, Valencia
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinico Universitario Lozano Blesa
Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario 12 De Octubre
Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Donostia
Medical Oncology, Pasealeku Doct. Begiristain 109, 20014, Donostia
Hospital Beata Maria Ana
Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario De Jaen
Medical Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Medical Oncology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Clinico San Cecilio
Oncology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Universitari General De Catalunya
Oncology, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Hospital Insular de Gran Canarias
Oncology, Avda Marítima, s/n., Las Palmas de Gran Canaria
Hospital Universitario De Salamanca
Oncology, Paseo De San Vicente 58-182, 37007, Salamanca
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital San Pedro De Alcantara
Oncology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 96 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol_2025-522791-92-00 JSGD_Addendum EU | 3.0 |
| Protocol (for publication) | D1 Protocol_2025-522791-92-00 JSGD_Redacted | a |
| Protocol (for publication) | D1_Protocol Addendum_2025-522791-92-00_GR | 1 |
| Protocol (for publication) | D1_Protocol_2025-522791-92-00_GR_Redacted | a |
| Protocol (for publication) | D4_Patient Facing Documents Copyright Statement | 1 |
| Protocol (for publication) | D4_Study Participant Contact Card_GR | 2 |
| Recruitment arrangements (for publication) | K1_Informed consent and Patient Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure template | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_ Part II Poster_Unapplied | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure Part 1_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure Part 1_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure Part 2_BEDU | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure Part 2_BEFR | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Part 1 | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Part 2 | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Part I Brochure_Unapplied | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Part I Poster_Unapplied | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Part II Brochure_Unapplied | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster Part 1_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster Part 1_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster Part 2_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster Part 2_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Part 1 | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Part 2 | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Site Recruitment_Kliniken Essen-Mitte_Evangelische Huyssens-Stiftung | 1 |
| Recruitment arrangements (for publication) | K3_Additionnal Document_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main_Part 1_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Main_Part 2_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Optional Activity_GR | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF Prescreening_GR | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Sponsor Statement_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Recruitment and Informed consent procedure | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Part 1_BEDU_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Part 1_BEFR_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Part 1_ENG_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Part 2_BEDU_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Part 2_BEFR_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Part 2_ENG_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Activity_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Activity_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Activity_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Screening Activity_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Screening Activity_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Screening Activity_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Genetic Research_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF Optional Activity Biopsy | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF Optional Genetic Research | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF Optional Screening | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF Pregnancy_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Optional Activity | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Optional Screening_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Pregnancy_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 1 - Dose Optimization _ Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2 - Phase III study_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 1_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 2_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Activity | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biopsy ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Screening | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Part 1_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Part 2_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Part I Main ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Part II Main ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner Consent | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Brochure_Part-1_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Brochure_Part-2_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Confidentiality Company Information Notice_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Poster_Part-1_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Poster_Part-2_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Study-Connect-Participant_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Visit-Card_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Study Participant Contact Card_GR | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Anastrozole 1mg tbl_RowaPharm | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Exemestane-Aromasin_Pfizer | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Fulvestrant-Faslodex_AstraZeneca AB | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Letrozole 2.5mg_Synthon | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Palbociclib-Ibrance_Pfizer | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Palbociclib-Ibrance_v2_Pfizer | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ribociclib-Kisqali_Novartis | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ribociclib-Kisqali_Novartis_v2 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis IT 2025-522791-92-00 Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522791-92-00_GR_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDE_2025-522791-92-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDU_2025-522791-92-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEFR_2025-522791-92-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EN_2025-522791-92-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2025-522791-92-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2025-522791-92-00_Redacted | a |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-14 | Italy | Acceptable with conditions 2026-03-23
|
2026-03-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-09 | Italy | Acceptable with conditions 2026-03-23
|
2026-04-09 |