Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,241
Countries
11
Sites
75
ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
To evaluate the efficacy of GDC-9545 combined with palbociclib compared with letrozole combined with palbociclib on the basis of progression-free survival (PFS)
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Dec 2020 → ongoing
- Decision date (initial)
- 2024-04-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche AG
External identifiers
- EU CT number
- 2023-506911-16-00
- EudraCT number
- 2020-000119-66
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Safety
To evaluate the efficacy of GDC-9545 combined with palbociclib compared with letrozole combined with palbociclib on the basis of progression-free survival (PFS)
Secondary objectives 4
- 1. To evaluate the efficacy of GDC-9545 combined with palbociclib compared with letrozole combined with palbociclib on the basis of Overall survival (OS), Objective response rate (ORR), Duration of response (DOR), Clinical benefit rate (CBR),Time to confirmed deterioration (TTCD) in pain level, TTCD in pain presence and interference, TTCD in physical functioning (PF), TTCD in role functioning (RF) and TTCD in global health status (GHS) and quality-of-life (QoL),
- 2. To evaluate the safety of GDC-9545 combined with palbociclib compared with letrozole combined with palbociclib
- 3. To characterize the GDC-9545 PK profile when given in combination with palbociclib (±LHRH agonist)
- 4. To characterize the palbociclib PK profile when given in combination with GDC-9545 (±LHRH agonist) or in combination with letrozole (± LHRH agonist)
Conditions and MedDRA coding
ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10027475 | Metastatic breast cancer | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY
|
Randomised Controlled | Double | [{"id":170861,"code":1,"name":"Subject"},{"id":170862,"code":5,"name":"Carer"},{"id":170863,"code":2,"name":"Investigator"},{"id":170860,"code":3,"name":"Monitor"}] | Arm A: GDC-9545 /placebo Arm B: palbociclib Arm C: letrozole/placebo |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
- IPD plan description
- N/A
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment
- Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
- Documented ER-positive tumor and HER2-negative tumor, assessed locally
- No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
- Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months
- Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
- Eastern Cooperative Oncology Group Performance Status 0-1
Exclusion criteria 7
- Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor
- Prior treatment with a selective estrogen receptor degrader
- Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization
- Advanced, symptomatic, visceral spread that is at risk of lifethreatening complications in the short term
- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
- Active cardiac disease or history of cardiac dysfunction
- Pregnant or breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Progression-free survival (PFS
Secondary endpoints 13
- 1. Overall survival (OS)
- 2. Objective response rate (ORR)
- 3. Duration of response (DOR)
- 4. Clinical benefit rate (CBR)
- 5. Time to confirmed deterioration (TTCD) in pain level
- 6. TTCD in pain presence and interference
- 7. TTCD in physical functioning (PF)
- 8. TTCD in role functioning (RF)
- 9. TTCD in global health status (GHS) and quality-of-life (QoL)
- 10. Incidence and severity of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0)
- 11. Change from baseline in targeted vital signs
- 12. Plasma concentration of GDC-9545 at specified timepoints
- 13. Plasma concentration of palbociclib at specified timepoints
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 7
PRD9858318 · Product
- Active substance
- Giredestrant
- Substance synonyms
- 3-((1R,3R)-1-(2,6-DIFLUORO-4-((1-(3-FLUOROPROPYL)AZETIDIN-3-YL)AMINO)PHENYL)-3-METHYL-1,3,4,9-TETRAHYDRO-2H-PYRIDO(3,4-B)INDOL-2-YL)-2,2-DIFLUOROPROPAN-1-OL, RG-6171, GDC-9545, RO7197597
- Other product name
- GDC-9545, Giredestrant
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 75 g gram(s)
- Max treatment duration
- 82 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD6503929 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 312 g gram(s)
- Max treatment duration
- 82 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
PRD6503927 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 312 g gram(s)
- Max treatment duration
- 82 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/003
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
PRD6503996 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 312 g gram(s)
- Max treatment duration
- 82 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/005
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
IBRANCE 75 mg film-coated tablets
PRD7907995 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 312 g gram(s)
- Max treatment duration
- 82 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/010
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trial use.
IBRANCE 125 mg film-coated tablets
PRD7907865 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 312 g gram(s)
- Max treatment duration
- 82 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/014
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trial use.
IBRANCE 100 mg film-coated tablets
PRD7907867 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 312 g gram(s)
- Max treatment duration
- 82 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/012
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trial use.
Comparator 1
PRD489676 · Product
- Active substance
- Letrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 6.2 g gram(s)
- Max treatment duration
- 82 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- 38895.00.00
- MA holder
- NOVARTIS PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use and relabeled to maintain blinding. Overencapsulated capsules
Placebo 2
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
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
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
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Median Technologies ORG-100041462
|
Valbonne, France | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Signant Health Management Limited ORG-100040504
|
Reading, United Kingdom | Other |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
Locations
11 EU/EEA countries · 75 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 7 | 3 |
| Belgium | Ongoing, recruitment ended | 5 | 2 |
| Denmark | Ongoing, recruitment ended | 6 | 3 |
| France | Ongoing, recruitment ended | 27 | 10 |
| Germany | Ongoing, recruitment ended | 57 | 19 |
| Greece | Ongoing, recruitment ended | 8 | 3 |
| Hungary | Ended | 5 | 2 |
| Italy | Ongoing, recruitment ended | 54 | 11 |
| Poland | Ongoing, recruitment ended | 14 | 3 |
| Portugal | Ongoing, recruitment ended | 14 | 4 |
| Spain | Ongoing, recruitment ended | 62 | 15 |
| Rest of world
Ukraine, Mexico, China, Canada, Turkey, Peru, United States, New Zealand, Israel, Argentina, Korea, Republic of, Hong Kong, Thailand, Australia, United Kingdom, Russian Federation, Japan, Brazil, Taiwan
|
— | 982 | — |
Investigational sites
Medical University of Vienna
Department of Internal Medicine I, Waehringer Guertel 18-20, Alsergrund, Vienna
Oberoesterreichische Gesundheitsholding GmbH
Department of Internal Medicine II, Sierninger Strasse 170, 4400, Steyr
SCRI CCCIT Ges.m.b.H.
Department of Internal Medicine III, Muellner Hauptstrasse 48, 5020, Salzburg
Jessa Ziekenhuis
Medical Oncology, Stadsomvaart 11, 3500, Hasselt
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Odense University Hospital
Onkologisk Afdeling R, J B Winsloews Vej 4, 5000, Odense C
Herlev Hospital
Afdeling for kræftbehandling, Borgmester Ib Juuls Vej 1, 2730, Herlev
Næstved Hospital
Onkologisk Afdeling, Ringstedgade 61, 4700, Næstved
Institut Regional Du Cancer De Montpellier
Oncologie, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Centre De Lutte Contre Le Cancer Eugene Marquis
Service d'oncologie, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Centre Hospitalier Universitaire De Saint Etienne
Oncologie, St Priest En Jarez, 25 Boulevard Pasteur, St Etienne Cedex 2
Institut De Cancerologie De Lorraine
Oncologie Medicale, 6 Avenue De Bourgogne, Cs 30519, Vandoeuvre Les Nancy Cedex
Institut De Cancerologie De L Ouest
Oncologie Medicale, 15 Rue Andre Boquel, 49100, Angers
Centre Hospitalier Universitaire De Poitiers
ONCOLOGIE MEDICALE, 2 Rue De La Miletrie, 86000, Poitiers
Institut Godinot
ONCOLOGIE MEDICALE, 1 Rue Du General Koenig, 51100, Reims
Centre Hospitalier De La Cote Basque
ONCOLOGIE, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Centre Hospitalier Departemental Vendee
Unité de Recherche Clinique Onco-Hematologie, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Du Puy
Oncologie et chimiothérapie, 12 Boulevard Docteur Chantemesse, 43000, Le Puy-En-Velay
Universitaetsklinikum Tuebingen AöR
Frauenklinik & Poliklinik, Calwerstrasse 7, Innenstadt, Tuebingen
Medizinische Hochschule Hannover
Zentrum für Frauenheilkunde Abteilung Gynäkologische Onkologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Gemeinschaftspraxis Fuer Haematologie Und Onkologie
N.A., Roentgenstrasse 6-8, 63225, Langen (Hessen)
National Center For Tumor Diseases (NCT) Heidelberg
Sektion Gynäkologische Onkologie, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Franziskus Hospital Harderberg
Zentrum für Onkologie und Hämatologie MVZ II, Alte Rothenfelder Strasse 23, Harderberg, Georgsmarienhuette
Ambulantes Tumorzentrum Spandau
N.A., Kosterstrasse 34/35, 13581, Berlin
Praxisnetzwerk Hämatologie und intern. Onkologie
Standort Troisdorf, Schloßstr. 18, (am St. Josef Hospital), Troisdorf
Institut Fuer Versorgungsforschung In Der Onkologie GbR
N.A., Neversstrasse 5, Sued, Koblenz
ConMed GmbH
OSP-Göttingen, Gemeinschaftspraxis: Meyer, Ammon, Metz, Müller, Nikolausberger Weg 34, 37073, Göttingen
University Medical Center Hamburg-Eppendorf
Klinik und Poliklinik für Gynäkologie, Martinistrasse 52, Eppendorf, Hamburg
Technische Universitat Dresden
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Studienzentrum Onkologie Ravensburg GmbH
N.A., Elisabethenstrasse 19, 88212, Ravensburg
Klinikum der Universitaet Muenchen AöR
Klinik und Poliklinik für Frauenheilkunde u Geburtshilfe, Ziemssenstrasse 1, Ludwigsvorstadt-Isarvorstadt, Munich
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Innere Medizin 1, Feldstrasse 16, Innenstadt, Trier
St. Elisabeth-Krankenhaus Leipzig gGMbH
Senologie/Brustzentrum, Biedermannstraße 84, 04277, Leipzig
Klinikum Chemnitz gGmbH
Klinik für Frauenheilkunde und Geburtshilfe, Flemmingstrasse 2, Altendorf, Chemnitz
Universitat Heidelberg
Frauenklinik, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Facharztzentrum Eppendorf
NORDDEUTSCHES STUDIENZENTRUM FÜR INNOVATIVE ONKOLOGIE, Eppendorfer Landstrasse 42, 20249, Hamburg
Universitaetsklinikum Essen AöR
Klinik für Frauenheilkunde und Geburtshilfe, Hufelandstrasse 55, Holsterhausen, Essen
St Savas Hospital
A’ Department of Oncology, Alexandras Avenue 171, 115 22, Athens
St Savas Hospital
2nd Department of Medical Oncology, Alexandras Avenue 171, 115 22, Athens
Athens Medical Center S.A.
3rd Department of Oncology, Pylea, Asklipiou 10, Thessaloniki
Budapesti Uzsoki Utcai Korhaz
Onkoradiológiai Osztály, Uzsoki Utca 29-41, 1145, Budapest XIV
Central Hospital Of Northern Pest Military Hospital
Onkologia osztaly, Podmaniczky Utca 109, 1062, Budapest VI
Fondazione IRCCS San Gerardo Dei Tintori
Oncologia Medica, Via Giovanni Battista Pergolesi 33, 20900, Monza
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Urologic and gynecologic oncology, Via Piero Maroncelli 40, 47014, Meldola
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
O.U. Oncology Department, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Unita Sanitaria Locale Toscana Nord Ovest
U.O.C. Oncologia Medica, Viale Vittorio Alfieri 36, 57124, Leghorn
European Institute Of Oncology S.r.l.
Senologia Medica, Via Giuseppe Ripamonti 435, 20141, Milan
Istituto Oncologico Veneto
Medical Oncology 2, Via Gattamelata 64, 35128, Padova
Azienda Unita' Locale Socio Sanitaria N. 8 Berica
Medical Oncology, Viale Ferdinando Rodolfi 37, 36100, Vicenza
I.F.O. Istituti Fisioterapici Ospitalieri
Medical Oncology 2, Via Elio Chianesi N 53, 00144, Rome
Humanitas Istituto Clinico Catanese S.p.A.
Oncologia Medica, Strada Provinciale 54 Contrada Cubba 11, 95045, Misterbianco
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Oncologia Medica, Strada Provinciale 142 Km 3,95, 10060, Candiolo
IRCCS Ospedale Sacro Cuore Don Calabria
UOC Oncologia Medica, Via Don Angelo Sempreboni 5, 37024, Negrar
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Szpitale Pomorskie Sp. z o.o.
Szpital Morski im.PCK O. Onkologii i Radioterapii, O. Onkologii Klinicznej-Leczenie "Jednego Dnia", Ul. Powstania Styczniowego 1, 81-519, Gdynia
Instituto Portugues De Oncologia Coimbra Francisco Gentil E.P.E.
Oncologia Médica, Avenida Doutor Bissaya Barreto 98, 3000-075, Coimbra
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Oncologia Médica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Hospital Da Luz S.A.
Oncologia, Avenida Lusiada 100, 1500-650, Lisbon
Hospital De Santa Maria E.P.E.
Oncologia Médica, Avenida Professor Egas Moniz Piso 3, 1649-028, Lisbon
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Donostia
Oncology, Pasealeku Doct. Begiristain 109, 20014, Donostia
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 | 2021-03-30 | 2021-05-20 | 2023-03-27 | ||
| Belgium | 2021-03-10 | 2022-07-08 | 2023-03-27 | ||
| Denmark | 2021-01-27 | 2021-03-18 | 2023-03-27 | ||
| France | 2021-01-22 | 2021-01-25 | 2023-03-27 | ||
| Germany | 2020-12-04 | 2020-12-10 | 2023-03-27 | ||
| Greece | 2021-03-31 | 2021-05-10 | 2023-03-27 | ||
| Hungary | 2021-03-23 | 2025-06-12 | 2021-03-29 | 2023-03-27 | |
| Italy | 2020-12-15 | 2020-12-23 | 2023-03-27 | ||
| Poland | 2021-01-14 | 2021-03-09 | 2023-03-27 | ||
| Portugal | 2021-03-11 | 2021-03-15 | 2023-03-27 | ||
| Spain | 2020-12-22 | 2020-12-23 | 2023-03-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 116 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-506911-16-00 Redacted | 4 |
| Protocol (for publication) | D1_Protocol 2023-506911-16-00 Redacted GR | 4 |
| Recruitment arrangements (for publication) | K_Rcuritment arrangements | 1 |
| Recruitment arrangements (for publication) | K_Recruit_arrangem_blank | 1 |
| Recruitment arrangements (for publication) | K_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K_Recruitment arrangements_doc | 1 |
| Recruitment arrangements (for publication) | K1_BO41843_DEU_Recruitment Arrangement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Filenote | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_REDACTED | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment rrangements | 2 |
| Recruitment arrangements (for publication) | K1_RecruitmentArrangement_AT | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_COVID-19 Addendum 1_PL | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_OPTIONAL Biopsy Progression_PL | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_OPTIONAL Biopsy_PL | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_OPTIONAL Phone and E-mail_PL | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_PPA_PL | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF addendum | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_REDACTED | 5 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF optional biopsy | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF pregnant partner | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF RBR | 3 |
| Subject information and informed consent form (for publication) | L1_Appendix 1 - GDPR | 1 |
| Subject information and informed consent form (for publication) | L1_BO41843_DEU ICF_RBR | 4.0 |
| Subject information and informed consent form (for publication) | L1_BO41843_DEU_ICF_Biopsy Cycle 1_2 | 2.0 |
| Subject information and informed consent form (for publication) | L1_BO41843_DEU_ICF_Biopsy_PD | 2.0 |
| Subject information and informed consent form (for publication) | L1_BO41843_DEU_ICF_ePRO | 1.0 |
| Subject information and informed consent form (for publication) | L1_BO41843_DEU_ICF_MAIN_Addendum 1 | 1.0 |
| Subject information and informed consent form (for publication) | L1_BO41843_DEU_ICF_MAIN_redactated | 5.0 |
| Subject information and informed consent form (for publication) | L1_BO41843_DEU_ICF_PD Brain metastasis | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF for pregnant partner | 3 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF pregnant patient | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_COVID | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_Gravid partner | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_Main | 6 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_HLuz_PK | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ICF_Mandatory genetics | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_Opc Contacts | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Opc RBR | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_Opcional Biopsy C1C2 | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_Opcional Biopsy PD | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional RBR | 4 |
| Subject information and informed consent form (for publication) | L1_ICF_PD optional biopsy | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_PPA | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_RBR | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_Valgfri biopsi progression | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Valgfri biopsi serie 1 eller 2 | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Visit optional biopsy | 3 |
| Subject information and informed consent form (for publication) | L1_Information for pregnant partner | 3 |
| Subject information and informed consent form (for publication) | L1_Privacy consent form other subjects | 1Nov23 |
| Subject information and informed consent form (for publication) | L1_S13 Genomdokument | 1 |
| Subject information and informed consent form (for publication) | L1_Samtykke til valgfri afgivelse af personlige kontaktoplysninger | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF COVID-19 Addendum 1_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF COVID-19 Addendum 1_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF COVID-19 Addendum 1_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF COVID-19 Addendum I | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN_EN_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN_FR_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN_NL_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_REDACTED | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_UA_Memo | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OPTIONAL BIOPSY PROGRESSION_UA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OPTIONAL RBR_UA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Phone and E-mail_UA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA ICF_EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA ICF_FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA ICF_NL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR ICF_EN | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR ICF_FR | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR ICF_NL | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_PL_REDACTED | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OPTIONAL RBR_PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement Information Sheet | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_BO41843_Anexo ICF COVID19 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_BO41843_General_FC Intensiva_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_BO41843_General_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_BO41843_Pareja embarazada | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_Mandatory genetics | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_Optional RBR | 4 |
| Subject information and informed consent form (for publication) | L1_SIS_PD optional biopsy | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_Visit optional biopsy | 3 |
| Subject information and informed consent form (for publication) | L1_SISandICF_AustrianRBR | 3.0 |
| Subject information and informed consent form (for publication) | L1_SISandICF_Main_AT_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SISandICF_OptionalBiopsy_AT | 1.2 |
| Subject information and informed consent form (for publication) | L1_SISandICF_PregnantPartner_AT | 2.1 |
| Subject information and informed consent form (for publication) | L1_SISandICF_WeiterbehandlungProgression | 1.1 |
| Subject information and informed consent form (for publication) | L2_Forsgspersoners rettigheder | 1 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L2_Sponsor Statement On Use Of ICF Model | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Palbociclib 2024 | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Palbociclib redline | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Palbociclib redline 2024 | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Letrozole | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Palbociclib | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2023-506911-16-00.pdf | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_at- 2023-506911-16-00 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_be-2020-000119-66 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_de-2020-000119-66 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_es-2020-000119-66 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr-2020-000119-66 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_gr-2020-000119-66 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_hu-2020-000119-66 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_it-2020-000119-66 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_nl be-2020-000119-66 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pl-2020-000119-66 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pt-2020-000119-66 | 4 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-21 | Germany | Acceptable 2024-03-27
|
2024-03-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-29 | Germany | Acceptable 2024-11-15
|
2024-11-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-09 | Acceptable | 2025-02-10 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-21 | Germany | Acceptable | 2025-01-23 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-31 | Acceptable | 2025-04-06 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-13 | Acceptable | 2025-02-21 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-05-28 | Germany | Acceptable 2025-07-25
|
2025-07-28 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-15 | Germany | Acceptable | 2025-10-01 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-11-06 | Germany | Acceptable 2025-12-11
|
2025-12-11 |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-02-13 | Acceptable | 2026-03-30 |