A study to Evaluate Efficacy and Safety of Giredestrant Compared with Fulvestrant (plus a CDK4/6 inhibitor), in Participants with ER+ HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

2022-502980-39-00 Protocol CO44657 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 25 Jan 2024 · Status Ongoing, recruiting · 13 EU/EEA countries · 110 sites · Protocol CO44657

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 1,050
Countries 13
Sites 110

Estrogen receptor (ER)-positive, HER2-negative advanced breast cancer

To evaluate the efficacy of giredestrant compared with fulvestrant in the ESR1 mutation detected (ESR1m) subgroup and full analysis set (FAS) 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
25 Jan 2024 → ongoing
Decision date (initial)
2024-01-22
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
F. Hoffmann La Roche

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy of giredestrant compared with fulvestrant in the ESR1 mutation detected (ESR1m) subgroup and full analysis set (FAS) on the basis of progression-free survival (PFS)

Secondary objectives 2

  1. To evaluate the safety of giredestrant compared with fulvestrant
  2. To evaluate the efficacy of giredestrant compared with fulvestrant based on PFS in the ESR1 no mutation detected (ESR1nmd) subgroup, and based on overall survival (OS), confirmed objective response rate (cORR), duration of response (DOR), clinical benefit rate (CBR), time to chemotherapy (TTCtx), time to confirmed deterioration (TTCD) in pain severity, presence and interference, TTCD in physical functioning (PF), role functioning (RF) and global health status / quality of life (GHS/QoL) in the ESR1m and ESR1nmd subgroups and in the FAS

Conditions and MedDRA coding

Estrogen receptor (ER)-positive, HER2-negative advanced breast cancer

VersionLevelCodeTermSystem organ class
23.0 LLT 10070575 Estrogen receptor positive breast cancer 10029104
21.1 LLT 10072737 Advanced breast cancer 10029104
28.0 LLT 10077484 HER2 negative 10022891

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Overall Design
This Phase III, randomized, open-label study will evaluate the efficacy and safety of giredestrant compared with fulvestrant, each combined with the investigator's choice of CDK4/6i between palbociclib, abemaciclib and ribociclib, as 1L treatment for patients with ER+, HER2- aBC resistant to prior adjuvant ET.
 Randomised Controlled None A: Participants in the experimental arm will receive giredestrant orally, as well as the investigator’s choice of CDK4/6i.
B: Participants in the control arm will receive intramuscular fulvestrant, as well as the investigator’s choice of CDK4/6i.

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 5

  1. Confirmed ESR1 mutation status in baseline ctDNA
  2. Resistance to prior standard adjuvant ET, defined as relapse on-treatment after ≥ 12 months or off-treatment within 12 months of completion. If adjuvant ET included a CDK4/6i, capecitabine, or S-1 relapse should have occurred ≥ 12 months since completion of CDK4/6i such treatment
  3. Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1
  5. Locally advanced or metastatic adenocarcinoma of the breast not amenable to treatment with curative intent, with documented ER+ HER2- status assessed locally based on the most recent tumor biopsy (or archived tumor sample if a recent tumor sample is not available for testing)

Exclusion criteria 5

  1. Prior treatment with a SERD (e.g., fulvestrant, investigational)
  2. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
  3. Active cardiac disease or history of cardiac dysfunction
  4. Clinically significant history of liver disease
  5. Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer. Prior therapy for contralateral, local, and/or regional BC treated with curative surgery is allowed

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 1. Progression-Free Survival (PFS), defined as time from randomization to first occurrence of disease progression (PD), as determined by the investigator according to RECIST v1.1, or death from any cause during the study (whichever occurs first), in the ESR1m subgroup and in the FAS

Secondary endpoints 12

  1. 1. PFS in the ESR1nmd subgroup
  2. 2. OS, defined as the time from randomization to death from any cause
  3. 3. cORR, defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1
  4. 4. DOR, defined as the time from the first occurrence of a documented objective response to PD, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first)
  5. 5. CBR, defined as the proportion of participants with stable disease for ≥ 24 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1
  6. 6. TTCtx, defined as the time from randomization until the start date of chemotherapy or death from any cause (whichever occurs first)
  7. 7. TTCD in pain severity, defined as the time from randomization to the first documentation of a ≥ 2-point increase from baseline on the “worst pain” item score from the BPI-SF
  8. 8. TTCD in pain presence and interference, defined as the time from randomization to the first documentation of a ≥ 10-point increase from baseline in the EORTC QLQ-C30 linearly transformed pain scale score
  9. 9. TTCD in PF, RF and GHS/QoL, defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline in the EORTC QLQ-C30 linearly transformed respective scale scores
  10. 10. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0
  11. 11. Change from baseline in selected vital signs
  12. 12. Change from baseline in selected clinical laboratory test results

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

RO7197597

PRD9491575 · 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
41 g gram(s)
Max treatment duration
60 Month(s)
Authorisation status
Not Authorised
MA holder
F. HOFFMANN-LA ROCHE LTD
Paediatric formulation
No
Orphan designation
No

Comparator 9

Faslodex 250 mg solution for injection.

PRD3545736 · Product

Active substance
Fulvestrant
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR USE
Max daily dose
500 mg milligram(s)
Max total dose
33 g gram(s)
Max treatment duration
60 Month(s)
Authorisation status
Authorised
ATC code
L02BA03 — FULVESTRANT
Marketing authorisation
EU/1/03/269/002
MA holder
ASTRAZENECA AB
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

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
171 g gram(s)
Max treatment duration
60 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
No

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
171 g gram(s)
Max treatment duration
60 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
No

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
171 g gram(s)
Max treatment duration
60 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
No

Kisqali 200 mg film-coated tablets

PRD5341551 · Product

Active substance
Ribociclib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
822 g gram(s)
Max treatment duration
60 Month(s)
Authorisation status
Authorised
ATC code
L01EF02 — -
Marketing authorisation
EU/1/17/1221/005
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ribociclib

SUB180246 · Substance

Active substance
Ribociclib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
822 g gram(s)
Max treatment duration
60 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Relabeled for CT use

Verzenios 150 mg film-coated tablets

PRD6701112 · Product

Active substance
Abemaciclib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
548 g gram(s)
Max treatment duration
60 Month(s)
Authorisation status
Authorised
ATC code
L01EF03 — -
Marketing authorisation
EU/1/18/1307/015
MA holder
ELI LILLY NEDERLAND B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Verzenios 100 mg film-coated tablets

PRD6701107 · Product

Active substance
Abemaciclib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
548 g gram(s)
Max treatment duration
60 Month(s)
Authorisation status
Authorised
ATC code
L01EF03 — -
Marketing authorisation
EU/1/18/1307/013
MA holder
ELI LILLY NEDERLAND B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Verzenios 50 mg film-coated tablets

PRD6701102 · Product

Active substance
Abemaciclib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
548 g gram(s)
Max treatment duration
60 Month(s)
Authorisation status
Authorised
ATC code
L01EF03 — -
Marketing authorisation
EU/1/18/1307/011
MA holder
ELI LILLY NEDERLAND B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Auxiliary 1

Leuprorelin

SCP1713601 · ATC

Active substance
Leuprorelin
Substance synonyms
LEUPROLIDE
Route of administration
INTRAMUSCULAR USE
Max daily dose
3.75 mg milligram(s)
Max total dose
248 mg milligram(s)
Max treatment duration
60 Month(s)
Authorisation status
Authorised
ATC code
L02AE02 — LEUPRORELIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

213 Total trials 63 Recruiting 141 Ended
Commercial
Sponsor organisation
F. Hoffmann-La Roche AG
Address
Building 686 Elsassertor, Centralbahnstrasse 4 Centralbahnstrasse 4
City
Basel Town
Postcode
4051
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 11

OrganisationCity, countryDuties
Labcorp Central Laboratory Services S.a.r.l.
ORG-100011524
 Meyrin, Switzerland Laboratory analysis
CellCarta
ORG-100039881
 Antwerp, Belgium Other
Swm Partners Limited
ORG-100047818
 Berkhamsted, United Kingdom Other
IQVIA RDS Hellas Single Member S.A.
ORG-100048380
 Chalandri, Greece On site monitoring
Foundation Medicine Inc.
ORG-100040457
 Boston, United States Laboratory analysis
Kayentis
ORG-100037894
 Meylan, France Other
Almac Clinical Technologies LLC
ORG-100043036
 Souderton, United States Interactive response technologies (IRT)
Median Technologies
ORG-100041462
 Valbonne, France Other
IQVIA Limited
ORG-100008655
 Reading, United Kingdom On site monitoring
Labcorp Central Laboratory Services LP
ORG-100032236
 Indianapolis, United States Laboratory analysis
Foundation Medicine GmbH
ORG-100040499
 Penzberg, Germany Other

Locations

13 EU/EEA countries · 110 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruiting 18 5
Belgium Ongoing, recruiting 17 8
Finland Ongoing, recruiting 7 2
France Ongoing, recruiting 38 13
Germany Ongoing, recruiting 25 10
Greece Ongoing, recruiting 16 5
Hungary Ongoing, recruiting 7 4
Italy Ongoing, recruiting 65 22
Poland Ongoing, recruiting 27 12
Portugal Ongoing, recruiting 15 5
Romania Ongoing, recruiting 16 8
Slovenia Ongoing, recruiting 5 1
Spain Ongoing, recruiting 40 15
Rest of world
Guatemala, Colombia, Turkey, Peru, New Zealand, Hong Kong, Costa Rica, Taiwan, Kenya, Mexico, South Africa, Argentina, India, Israel, Brazil, Canada, Singapore, United States, Thailand, Korea, Republic of, Australia, Chile, China
 — 754 —

Investigational sites

Austria

5 sites · Ongoing, recruiting
Medizinische Universitaet Innsbruck
University Hospital for Gynaecology and Obstetrics (Breast Health Center), Anichstrasse 35, 6020, Innsbruck
Medical University Of Graz
Clinical department of oncology, Neue Stiftingtalstrasse 6, 8010, Graz
Medical University of Vienna
Department of Medicine I, Division of Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna
Oberoesterreichische Gesundheitsholding GmbH
Department of Medicine II, Sierninger Strasse 170, 4400, Steyr
Ordensklinikum Linz GmbH
Department of Hematology and Oncology, Seilerstaette 4, 4020, Linz

Belgium

8 sites · Ongoing, recruiting
Grand Hopital De Charleroi
Oncology, Rue Du Campus Des Viviers 1, 6060, Charleroi
Emmaues
Oncology, Liersesteenweg 435, 2800, Mechelen
Universitair Ziekenhuis Gent
Oncology, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
CHU UCL Namur
Oncology, Place Louise Godin 15, 5000, Namur
Gasthuiszusters Antwerpen
Oncology, Oosterveldlaan 24, 2610, Antwerp
CHU De Liege
Oncology, Avenue De L'hopital 1, 4000, Liege
UZ Leuven
Gynecological Oncology, Herestraat 49, 3000, Leuven

Finland

2 sites · Ongoing, recruiting
Kuopio University Hospital
Oncology Clinic, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
Tampere University Hospital
Oncology Clinic, Teiskontie 35, 33520, Tampere

France

13 sites · Ongoing, recruiting
Centre De Lutte Contre Le Cancer Eugene Marquis
medical oncology, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Centre Oscar Lambret
medical oncology, 3 Rue Frederic Combemale, 59000, Lille
Institut Godinot
medical oncology, 1 Rue Du General Koenig, 51100, Reims
Centre Francois Baclesse
medical oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Besancon University Hospital Center
medical oncology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Institut De Cancerologie De L Ouest
Oncology, 15 Rue Andre Boquel, 49100, Angers
Centre Leon Berard
medical oncology, 28 Rue Laennec, 69008, Lyon
Sainte Catherine Institut Du Cancer Avignon-Provence
medical oncology, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Centre De Cancerologue Du Grand Montpellier
medical oncology, 25 Rue De Clementville, 34070, Montpellier
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
medical oncology, 1 Rue Du Docteur Schweitzer, 17000, La Rochelle
Institut Gustave Roussy
medicine, 39 Rue Camille Desmoulins, 94805, Villejuif Cedex
Institut Universitaire Du Cancer Toulouse-Oncopole
medical oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Jean Perrin
medical oncology, 58 Rue Montalembert, 63000, Clermont-Ferrand

Germany

10 sites · Ongoing, recruiting
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
N.A., Ludwig-Weber-Strasse 15, Stadtmitte, Moenchengladbach
National Center For Tumor Diseases (NCT) Heidelberg
Gynäkologische Onkologie, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Saarland University Hospital
Klinik für Frauenheilkunde und Geburtshilfe, Kirrberger Strasse 100, 66421, Homburg
MVZ Medical Center Duesseldorf GmbH
Zentrum für Gynäkologische Onkologie, Luise-Rainer-Strasse 6-10, Flingern Nord, Duesseldorf
Rotkreuzklinikum Muenchen gGmbH
Frauenklinik, Taxisstrasse 3, Neuhausen-Nymphenburg, Munich
KEM I Evang. Kliniken Essen-Mitte gGmbH
Klinik für Frauenheilkunde / Brustzentrum, Henricistrasse 92, Huttrop, Essen
Universitaetsklinikum Erlangen AöR
Frauenklinik, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Sozialstiftung Bamberg
Klinik für Frauenheilkunde und Geburtshilfe, Buger Strasse 80, Berg, Bamberg
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
N.A., Wirthstrasse 11c, Landwasser, Freiburg Im Breisgau
St. Elisabeth Krankenhaus GmbH
Brustzentrum / Senologie, Werthmannstrasse 1, Lindenthal, Cologne

Greece

5 sites · Ongoing, recruiting
St Savas Hospital
2nd Department of Medical Oncology, Alexandras Avenue 171, 115 22, Athens
General University Hospital Of Patras
Division of Oncology, Department of Medicine, Rio, 265 04, Patras
Areteio Hospital
B'Surgery Clinic, Oncology Unit, Vassilissas Sofias Avenue 76, 115 28, Athens
Athens Medical Center S.A.
3rd Oncology Clinic, Pylea, Asklipiou 10, Thessaloniki
General University Hospital Of Larissa
Oncology Department Internal Medicine, P. O. Box 1425, 411 10, Larissa

Hungary

4 sites · Ongoing, recruiting
Nograd Varmegyei Szent Lazar Korhaz
Onkologiai es Sugarterapias Centrum, Fuleki ut 54 - 56., 3100, Salgotarjan
Orszagos Onkologiai Intezet
Gyogyszerterapias Kozpont, Mellkasi es Hasuregi Daganatok es Klinikai Farmakologiai Osztaly, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Bacs-Kiskun Varmegyei Oktatokorhaz
Onkoradiologiai Kozpont, Nyiri Ut 38, 6000, Kecskemet
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Klinikai Onkolgiai es Sugarterapias Centrum, Onkologiai Osztaly, Szentpeteri Kapu 72-76, 3526, Miskolc

Italy

22 sites · Ongoing, recruiting
Azienda Ospedaliera Sant'anna E San Sebastiano Di Caserta
Oncologia, Via Ferdinando Palasciano Snc, 81100, Caserta
Azienda Sanitaria Universitaria Friuli Centrale
Oncologia, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Azienda Socio Sanitaria Territoriale Di Cremona
Unità di Patologia Mammaria Senologia e Breast Unit, Viale Concordia 1, 26100, Cremona
Centro Di Riferimento Oncologico Di Aviano
Oncologia Medica, Via Franco Gallini 2, 33081, Aviano
Humanitas Istituto Clinico Catanese S.p.A.
Oncologia, Strada Provinciale 54 Contrada Cubba 11, 95045, Misterbianco
AORN San Giuseppe Moscati Avellino
Oncologia, Contrada Amoretta, 83100, Avellino
Azienda Ospedaliero Universitaria Parma
Oncologia, Viale Antonio Gramsci 14, 43126, Parma
Istituto Oncologico Veneto
Oncologia Medica, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliera Universitaria Federico II Di Napoli
Oncologia Medica, Via Sergio Pansini 5, 80131, Naples
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia, Via Piero Maroncelli 40, 47014, Meldola
Humanitas Research Hospital
Oncologia Medica, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oncologia Medica, Via Pietro Albertoni 15, 40138, Bologna
IRCCS Istituto Nazionale Tumori Fondazione Pascale
U.O.C. Oncologia Medica Senologica, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Oncologia, Corso Giuseppe Mazzini 18, 28100, Novara
Azienda Sanitaria Locale Br
Oncologia Medica, Via Napoli 8, 72100, Brindisi
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
SC Oncologia, Piazza Oms 1, 24127, Bergamo
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Oncologia Medica, Piazzale Spedali Civili 1, 25123, Brescia
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia, Via Giacomo Venezian 1, 20133, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncologia, Largo Francesco Vito 1, 00168, Rome
Fondazione Policlinico Universitario Campus Bio-Medico
Oncologia Medica, Via Alvaro Del Portillo N 200, 00128, Rome
Careggi University Hospital
Radioterapia e Oncologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Ospedale Generale Provinciale Di Macerata
Oncologia, Via Santa Lucia 2, 62100, Macerata

Poland

12 sites · Ongoing, recruiting
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Klinika Onkologii z Odcinkiem Dziennym, Ul. Katowicka 66a, 45-061, Opole
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Centrum Diagnostyki i Leczenia Chorób Piersi, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii I, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Przychodnia Lekarska "Komed" Roman Karaszewski
NA, Wojska Polskiego 6, 62-500, Konin
Zachodniopomorskie Centrum Onkologii
Ośrodek Innowacyjności, Rozwoju i Badań Klinicznych, Ul. Strzalowska 22, 71-730, Szczecin
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Oddział Onkologii Klinicznej i Radioterapii, Ul. Ksiecia Jozefa Poniatowskiego 26, 08-110, Siedlce
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddział Dzienny Chemioterapii, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Institute Of Polish Mother's Health Center
Klinika Onkologii, Ul. Rzgowska 281/289, 93-338, Lodz
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddział Onkologii Klinicznej, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Dział Chemioterapii, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Szpitale Pomorskie Sp. z o.o.
Szpital Morski im. PCK, Oddział onkologii i radioterapii, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw

Portugal

5 sites · Ongoing, recruiting
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Serviço de Oncologia, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Hospital De Sao Francisco Xavier
Serviço de Oncologia, Estrada Forte Do Alto Duque, 1449-005, Lisbon
Instituto Portugues De Oncologia Coimbra Francisco Gentil E.P.E.
Serviço de Oncologia, Avenida Doutor Bissaya Barreto 98, 3000-075, Coimbra
Hospital Da Luz S.A.
Serviço de Oncologia, Avenida Lusiada 100, 1500-650, Lisbon
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
Serviço de Oncologia, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia

Romania

8 sites · Ongoing, recruiting
Institutul Regional De Oncologie Iasi
Oncologie medicala, Strada Sararie 177b, 700451, Iasi
Onco Clinic Consult S.A.
Oncologie medicala, Strada Sararilor 28j, 200508, Craiova
Spitalul Clinic Filantropia
Oncology, Bulevardul Mihalache Ion 11-13, 011171, Bucharest
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Radiotherapy Center Cluj S.R.L.
Oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Oncomed S.R.L.
Oncology, Strada Porumbescu Ciprian Nr 59, 300239, Timisoara
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Oncology, Soseaua Fundeni 252, 022328, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca

Slovenia

1 site · Ongoing, recruiting
Institute Of Oncology Ljubljana
Division of Medical Oncology, Zaloska Cesta 2, 1000, Ljubljana

Spain

15 sites · Ongoing, recruiting
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
University Clinical Hospital Virgen De La Arrixaca
Oncology, Carretera De Cartagena Sn, El Palmar, Murcia
Vall D Hebron Institute Of Oncology
Oncology, Calle Natzaret 115, 08035, Barcelona
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Arnau De Vilanova De Valencia
Oncology, Calle De San Clemente 12, 46015, Valencia
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario Juan Ramon Jimenez
Oncology, Ronda Exterior Norte S/n, 21005, Huelva
Complexo Hospitalario Universitario De Vigo
Oncology, Estrada Clara Campoamor N 341, 36312, Vigo
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Institut Catala D'oncologia
Oncology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario De Jaen
Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital De Jerez De La Frontera
Oncology, Carretera De La Ronda Circunvalacion S/n, 11408, Jerez De La Frontera
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle De Gregorio Gea 3 1 A Planta, 46009, Valencia

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2024-06-25 2024-06-25
Belgium 2024-02-14 2024-03-05
Finland 2024-06-10 2025-01-02
France 2024-04-09 2024-04-18
Germany 2024-04-29 2024-06-13
Greece 2024-09-23 2024-09-26
Hungary 2024-04-18 2024-04-22
Italy 2024-03-12 2024-03-18
Poland 2024-03-26 2024-04-12
Portugal 2024-01-25 2024-01-29
Romania 2024-12-02 2024-12-03
Slovenia 2024-07-11 2025-01-30
Spain 2024-02-08 2024-02-19

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 406 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2022-502980-39-00 GR Redacted 3
Protocol (for publication) D1_Protocol 2022-502980-39-00 Redacted 3
Protocol (for publication) D1_Protocol Clarification Letter 2022-502980-39-00 Redacted 1
Protocol (for publication) D1_Protocol Clarification Letter_2 2022-502980-39-00 Redacted N/A
Protocol (for publication) D1_Protocol Clarification Letter_3 2022-502980-39-00 Redacted N/A
Protocol (for publication) D1_Protocol Clarification Letter_4 2022-502980-39-00 Redacted N/A
Protocol (for publication) D4_Patient facing documents_BPI-SF_DE-AT.pdf 1
Protocol (for publication) D4_Patient facing documents_BPI-SF_DE-DE.pdf 1
Protocol (for publication) D4_Patient facing documents_BPI-SF_EN.pdf 1
Protocol (for publication) D4_Patient facing documents_BPI-SF_ES-ES.pdf 1
Protocol (for publication) D4_Patient facing documents_BPI-SF_FR-BE.pdf 1
Protocol (for publication) D4_Patient facing documents_BPI-SF_FR-FR.pdf 1
Protocol (for publication) D4_Patient facing documents_BPI-SF_GR-GR.pdf 1
Protocol (for publication) D4_Patient facing documents_BPI-SF_HU-HU.pdf 1
Protocol (for publication) D4_Patient facing documents_BPI-SF_IT-IT.pdf 1
Protocol (for publication) D4_Patient facing documents_BPI-SF_NL-BE.pdf 1
Protocol (for publication) D4_Patient facing documents_BPI-SF_PT N/A
Protocol (for publication) D4_Patient facing documents_BPI-SF_RO-RO.pdf 1
Protocol (for publication) D4_Patient facing documents_BPI-SF_SL-SL.pdf 1
Protocol (for publication) D4_Patient facing documents_CTCAE_DE-AT.pdf 1
Protocol (for publication) D4_Patient facing documents_CTCAE_DE-DE.pdf 1
Protocol (for publication) D4_Patient facing documents_CTCAE_EN.pdf 1
Protocol (for publication) D4_Patient facing documents_CTCAE_ES-ES.pdf 1
Protocol (for publication) D4_Patient facing documents_CTCAE_FR-BE.pdf 1
Protocol (for publication) D4_Patient facing documents_CTCAE_FR-FR.pdf 1
Protocol (for publication) D4_Patient facing documents_CTCAE_GR-GR.pdf 1
Protocol (for publication) D4_Patient facing documents_CTCAE_HU-HU.pdf 1
Protocol (for publication) D4_Patient facing documents_CTCAE_IT-IT.pdf 1
Protocol (for publication) D4_Patient facing documents_CTCAE_NL-BE.pdf 1
Protocol (for publication) D4_Patient facing documents_CTCAE_PT 1
Protocol (for publication) D4_Patient facing documents_CTCAE_RO-RO.pdf 1
Protocol (for publication) D4_Patient facing documents_CTCAE_SL-SL.pdf 1
Protocol (for publication) D4_Patient facing documents_EQ5D5L_BE-FR.pdf 1
Protocol (for publication) D4_Patient facing documents_EQ5D5L_BE-NL.pdf 1
Protocol (for publication) D4_Patient facing documents_EQ5D5L_DE-AT.pdf 1
Protocol (for publication) D4_Patient facing documents_EQ5D5L_DE-DE.pdf 1
Protocol (for publication) D4_Patient facing documents_EQ5D5L_EN.pdf 1
Protocol (for publication) D4_Patient facing documents_EQ5D5L_ES-ES.pdf 1
Protocol (for publication) D4_Patient facing documents_EQ5D5L_FR-FR.pdf 1
Protocol (for publication) D4_Patient facing documents_EQ5D5L_GR-GR.pdf 1
Protocol (for publication) D4_Patient facing documents_EQ5D5L_HU-HU.pdf 1
Protocol (for publication) D4_Patient facing documents_EQ5D5L_IT-IT.pdf 1
Protocol (for publication) D4_Patient facing documents_EQ5D5L_PT 1
Protocol (for publication) D4_Patient facing documents_EQ5D5L_RO-RO.pdf 1
Protocol (for publication) D4_Patient facing documents_EQ5D5L_SL-SL.pdf 1
Protocol (for publication) D4_Patient facing documents_GP5_BE-NL.pdf 1
Protocol (for publication) D4_Patient facing documents_GP5_DE-AT.pdf 1
Protocol (for publication) D4_Patient facing documents_GP5_DE-DE.pdf 1
Protocol (for publication) D4_Patient facing documents_GP5_EN.pdf 1
Protocol (for publication) D4_Patient facing documents_GP5_ES-ES.pdf 1
Protocol (for publication) D4_Patient facing documents_GP5_FR-FR.pdf 1
Protocol (for publication) D4_Patient facing documents_GP5_GR-GR.pdf 1
Protocol (for publication) D4_Patient facing documents_GP5_HU-HU.pdf 1
Protocol (for publication) D4_Patient facing documents_GP5_IT-IT.pdf 1
Protocol (for publication) D4_Patient facing documents_GP5_PT 4
Protocol (for publication) D4_Patient facing documents_GP5_RO-RO.pdf 1
Protocol (for publication) D4_Patient facing documents_GP5_SL-SL.pdf 1
Protocol (for publication) D4_Patient facing documents_GP5.pdf 1
Protocol (for publication) D4_Patient facing documents_Medication Diary_Fulvestrant & Abemabociclib_DE-DE.pdf 1
Protocol (for publication) D4_Patient facing documents_Medication Diary_Fulvestrant & Abemaciclib_AT-DE.pdf 1
Protocol (for publication) D4_Patient facing documents_Medication Diary_Fulvestrant & Abemaciclib_BE-FR.pdf 1
Protocol (for publication) D4_Patient facing documents_Medication Diary_Fulvestrant & Abemaciclib_BE-NL.pdf 1
Protocol (for publication) D4_Patient facing documents_Medication Diary_Fulvestrant & Abemaciclib_EN.pdf 1
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Protocol (for publication) D4_Patient facing documents_Medication Diary_Fulvestrant & Abemaciclib_HU.pdf 1
Protocol (for publication) D4_Patient facing documents_Medication Diary_Fulvestrant & Abemaciclib_IT.pdf 1
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Protocol (for publication) D4_Patient facing documents_Medication Diary_Fulvestrant & Ribociclib_AT-DE.pdf 1.1
Protocol (for publication) D4_Patient facing documents_Medication Diary_Fulvestrant & Ribociclib_BE-FR.pdf 1
Protocol (for publication) D4_Patient facing documents_Medication Diary_Fulvestrant & Ribociclib_BE-NL.pdf 1
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Protocol (for publication) D4_Patient facing documents_Medication Diary_Giredestrant-Abemacicib_ENG Redline 2
Protocol (for publication) D4_Patient facing documents_Medication Diary_Giredestrant-Ribociclib_ENG Redline 2
Protocol (for publication) D4_Patient facing documents_QLQBR23_AT-DE 1
Protocol (for publication) D4_Patient facing documents_QLQBR23_BE-FR.pdf 1
Protocol (for publication) D4_Patient facing documents_QLQBR23_BE-NL.pdf 1
Protocol (for publication) D4_Patient facing documents_QLQBR23_DE-DE.pdf 1
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Protocol (for publication) D4_Patient facing documents_QLQBR23_IT-IT.pdf 1
Protocol (for publication) D4_Patient facing documents_QLQBR23_PT 1
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Protocol (for publication) D4_Patient facing documents_QLQBR30_AT-DE.pdf 1
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Recruitment arrangements (for publication) K1_ Recruitment arrangements 2
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Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
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Recruitment arrangements (for publication) K1_Recruitment arrangements 2.0
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Recruitment arrangements (for publication) K1_Recruitment Arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements_CO44657 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_Romania 1
Recruitment arrangements (for publication) K1_Recrutiment Arrangements 2
Recruitment arrangements (for publication) K1_Recrutment_and_Informed_Consent_Procedure 1
Recruitment arrangements (for publication) K2_ Recruitment material_Clinical Trial Leaflet 2.0
Recruitment arrangements (for publication) K2_ Recruitment material_FB_Instagram_Campaign 2
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Recruitment arrangements (for publication) K2_Recruitment material_Poster 1
Recruitment arrangements (for publication) K2_Social Media Posts_CO44657 1
Subject information and informed consent form (for publication) CO44657 ICF Recien nacido v1 2023_08_21 ES 1
Subject information and informed consent form (for publication) CO44657 Summary for patient materials 4
Subject information and informed consent form (for publication) L1_ SIS and ICF IAF 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Main REDACTED 4
Subject information and informed consent form (for publication) L1_ SIS and ICF Optional Procedure_REDACTED 1
Subject information and informed consent form (for publication) L1_ SIS and ICF PPA 1
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Subject information and informed consent form (for publication) L1__SIS and ICF RBR_redacted 1
Subject information and informed consent form (for publication) L1_CO44657 ICF Genetic 1.1
Subject information and informed consent form (for publication) L1_CO44657 ICF IAF 1.1
Subject information and informed consent form (for publication) L1_CO44657 ICF Main_Redacted 4.0
Subject information and informed consent form (for publication) L1_CO44657 ICF Optional FM_Redacted 1.1
Subject information and informed consent form (for publication) L1_CO44657 ICF Optional Procedure_Redacted 1.1
Subject information and informed consent form (for publication) L1_CO44657 ICF Optional RBR_Redacted 2.0
Subject information and informed consent form (for publication) L1_CO44657 ICF PPA 1.1
Subject information and informed consent form (for publication) L1_CO44657 ICF Prescreening_Redacted 1.0
Subject information and informed consent form (for publication) L1_CO44657 Reimbursement Information Sheet_EU_Greenphire 2.0
Subject information and informed consent form (for publication) L1_IAF Infant Locally adapted_EN 2
Subject information and informed consent form (for publication) L1_IAF Infant Locally adapted_RO 2
Subject information and informed consent form (for publication) L1_IAF Infant Master_EN 1
Subject information and informed consent form (for publication) L1_ICF_Mandatory genetic_Redacted 1
Subject information and informed consent form (for publication) L1_ICF_Optional procedure_Redacted 1
Subject information and informed consent form (for publication) L1_ICF_Prescreening RBR 1
Subject information and informed consent form (for publication) L1_ICF_RBR 2
Subject information and informed consent form (for publication) L1_PPA Adults Locally adapted_EN 1
Subject information and informed consent form (for publication) L1_PPA Adults Locally adapted_RO 1
Subject information and informed consent form (for publication) L1_PPA Adults Master_EN 1
Subject information and informed consent form (for publication) L1_Privacy consent form other subjects NA
Subject information and informed consent form (for publication) L1_SIS Additional Information leaflet_clean redacted 6
Subject information and informed consent form (for publication) L1_SIS and ICF addendum_redacted 1
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Subject information and informed consent form (for publication) L1_SIS and ICF collect data infant 1
Subject information and informed consent form (for publication) L1_SIS and ICF FMI_CO44657_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF for Optional use for existing samples_clean redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF Greenphire Reimbursement Information Sheet 8.0
Subject information and informed consent form (for publication) L1_SIS and ICF Greenphire Reimbursement Information Sheet 8.0
Subject information and informed consent form (for publication) L1_SIS and ICF Greenphire Reimbursement Information Sheet 8.0
Subject information and informed consent form (for publication) L1_SIS and ICF IAF 1
Subject information and informed consent form (for publication) L1_SIS and ICF IAF 1
Subject information and informed consent form (for publication) L1_SIS and ICF IAF 1
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Subject information and informed consent form (for publication) L1_SIS and ICF IAF 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF IAF 1.0
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Subject information and informed consent form (for publication) L1_SIS and ICF Main ICF_FR_REDACTED 4.0
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Subject information and informed consent form (for publication) L1_SIS and ICF Main ICF_Locally adapted_RO_redacted 3
Subject information and informed consent form (for publication) L1_SIS and ICF Main ICF_NL_REDACTED 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF main research_REDACTED 3
Subject information and informed consent form (for publication) L1_SIS and ICF main study_REDACTED 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_CO44657_redacted 11.0
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 Main_Redacted 5
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Procedures_CO44657_redacted 2.0
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Subject information and informed consent form (for publication) L1_SIS and ICF optional sample_redacted 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 2
Subject information and informed consent form (for publication) L1_SIS and ICF PPA 2
Subject information and informed consent form (for publication) L1_SIS and ICF PPA 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF PPA 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF PPA 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pre-srcreening Inform Consent Form_clean_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF pregnant partner 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF pregnant partner 1
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnant Patient_CO44657 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening 1
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening 1
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening GRv1_ENv2_Clean_REDACTED 1
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening ICF_EN_REDACTED 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening ICF_FR_REDACTED 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening ICF_NL_REDACTED 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening_CO44657_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening_EN 1
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening_Locally adapted_EN_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening_Locally adapted_RO_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening_REDACTED 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening_REDACTED 1
Subject information and informed consent form (for publication) L1_SIS and ICF RBR Prescreening_REDACTED 1
Subject information and informed consent form (for publication) L1_SIS and ICF RBR Prescreening_REDACTED 1
Subject information and informed consent form (for publication) L1_SIS and ICF RBR redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF RBR_REDACTED 2
Subject information and informed consent form (for publication) L1_SIS and ICF_Authorization for the use and sharing of Pregnancy Health info 1
Subject information and informed consent form (for publication) L1_SIS and ICF_CO44657_FMI_REDACTED 1
Subject information and informed consent form (for publication) L1_SIS and ICF_CO44657_general_REDACTED 4
Subject information and informed consent form (for publication) L1_SIS and ICF_CO44657_PPA_REDACTED 2
Subject information and informed consent form (for publication) L1_SIS and ICF_CO44657_RBR_REDACTED 2
Subject information and informed consent form (for publication) L1_SIS and ICF_GDPR_Redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_Infants 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 procedure_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_optional use of pre-existing sample_REDACTED 1
Subject information and informed consent form (for publication) L1_SIS and ICF_pre-screening 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening 1
Subject information and informed consent form (for publication) L1_SIS Data Privacy Information sheet appendix 1 1
Subject information and informed consent form (for publication) L1_SIS ICF and Master Inform Consent_redacted 6
Subject information and informed consent form (for publication) L1_SIS_Mandatory genetic_Redacted 1
Subject information and informed consent form (for publication) L1_SIS_Optional procedure_Redacted 1
Subject information and informed consent form (for publication) L1_SIS_Prescreening RBR_Redacted 1
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Subject information and informed consent form (for publication) L1_SISandICF_optionalProcedure_redacted 1.1
Subject information and informed consent form (for publication) L1_SISandICF_optionalRBR_redacted 2.0
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Subject information and informed consent form (for publication) L1_SISandICF_PPA and IAF 1.1
Subject information and informed consent form (for publication) L1_SISandICF_Prescreening_redacted 1.1
Subject information and informed consent form (for publication) L2_CO44657_Other subject information material_Introduction Brochure_all enrolling_Redacted 1.0
Subject information and informed consent form (for publication) L2_CO44657_Other subject information material_Introduction Brochure_ESR1 only_Redacted 1.0
Subject information and informed consent form (for publication) L2_Informed Consent Form Procedure_REDACTED 1
Subject information and informed consent form (for publication) L2_Lay CTD 1.0
Subject information and informed consent form (for publication) L2_Memo Clarification on Patient Documents 1
Subject information and informed consent form (for publication) L2_Other subject information material recruitment brochure ESR1 et ESR1nmd redacted 1
Subject information and informed consent form (for publication) L2_Other subject information material recruitment brochure ESR1 only redacted 1
Subject information and informed consent form (for publication) L2_Other subject information material_BPI-SF_Portuguese-Portugal_CURRENT 1
Subject information and informed consent form (for publication) L2_Other subject information material_BR23 Portuguese Portugal 1 0 1
Subject information and informed consent form (for publication) L2_Other subject information material_Effective_REPR_PT_EQ-5D-5L Digital Self-Complete v1 1 1
Subject information and informed consent form (for publication) L2_Other subject information material_GP5_POR_Final_Ver4_ePRO_23Aug16 1
Subject information and informed consent form (for publication) L2_Other subject information material_pro-ctcae_PT_6464a8f0 1
Subject information and informed consent form (for publication) L2_Other subject information material_QLQ_C30 Portuguese 1 3 1
Subject information and informed consent form (for publication) L2_Other subject information material_SIB_ESR1nmd and ESR1m enrolling_REDACTED 1
Subject information and informed consent form (for publication) L2_Other subject information material_SIB_only ESR1m enrolling_REDACTED 1
Subject information and informed consent form (for publication) L2_Other subject information material_Study Introduction Brochure_ESR1m only 1
Subject information and informed consent form (for publication) L2_Other subject information material_Study Introduction Brochure_ESR1nmd and ESR1m 1
Subject information and informed consent form (for publication) L2_Other subject information material_Study-Introduction-Brochure-ESR1nmd-and-ESR1m-enrolling 1
Subject information and informed consent form (for publication) L2_Other subject information material_Study-Introduction-Brochure-only ESR1m-enrolling 1
Subject information and informed consent form (for publication) L2_Other subject information material_Visit Guide 3
Subject information and informed consent form (for publication) L2_Other subject information_SIB_ESR1m and ESR1nmd enrolling_REDACTED 1
Subject information and informed consent form (for publication) L2_Other subject information_SIB_only ESR1m enrolling_REDACTED 1
Subject information and informed consent form (for publication) L2_Other subject information_Visit guide 3
Subject information and informed consent form (for publication) L2_OtherSubjectInformationMaterial_Study Introduction Brochure 1.0
Subject information and informed consent form (for publication) L2_Patient Participation Card 1
Subject information and informed consent form (for publication) L2_pionERA_Study Introduction Brochure_based on Global ICF V3 ESR1nmd and ESR1m enrolling_V1_R 1
Subject information and informed consent form (for publication) L2_pionERA_Study Introduction Brochure_based on Global ICF V3 only ESR1m enrolling_V1_REDACTED 1
Subject information and informed consent form (for publication) L2_Sponsor Statement On Use Of ICF Model 1
Subject information and informed consent form (for publication) L2_Study Introduction Brochure ESR1nmd and ESR1m enrolling_EN_REDACTED 1.0
Subject information and informed consent form (for publication) L2_Study Introduction Brochure ESR1nmd and ESR1m enrolling_FR_REDACTED 1.0
Subject information and informed consent form (for publication) L2_Study Introduction Brochure ESR1nmd and ESR1m enrolling_NL_REDACTED 1.0
Subject information and informed consent form (for publication) L2_Study Introduction Brochure Only ESR1m enrolling_EN_REDACTED 1.0
Subject information and informed consent form (for publication) L2_Study Introduction Brochure Only ESR1m enrolling_FR_REDACTED 1.0
Subject information and informed consent form (for publication) L2_Study Introduction Brochure Only ESR1m enrolling_NL_REDACTED 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC abemaciclib NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC fulvestrant NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC palbociclib N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ribociclib NA
Summary of Product Characteristics (SmPC) (for publication) e2_smpc-abemaciclib redline NA
Summary of Product Characteristics (SmPC) (for publication) e2_smpc-fulvestrant redline NA
Summary of Product Characteristics (SmPC) (for publication) e2_smpc-palbociclib redline N/A
Summary of Product Characteristics (SmPC) (for publication) e2_smpc-ribociclib redline NA
Synopsis of the protocol (for publication) D1_Protocol synopsis_AT-DE 2022-502980-39-00.pdf 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_BE-DE 2022-502980-39-00.pdf 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_BE-FR 2022-502980-39-00.pdf 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_BE-NL 2022-502980-39-00.pdf 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_DE-DE 2022-502980-39-00.pdf 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_ENG 2022-502980-39-00.pdf 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES-ES 2022-502980-39-00.pdf 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_FR-FR 2022-502980-39-00.pdf 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_GR-GR 2022-502980-39-00.pdf 1.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_HU-HU 2022-502980-39-00.pdf 1.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_IT-IT 2022-502980-39-00.pdf 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_PL-PL 2022-502980-39-00.pdf 1.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_PT-PT 2022-502980-39-00.pdf 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_RO-RO 2022-502980-39-00.pdf 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_SL-SL 2022-502980-39-00.pdf 1

Application history

17 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-09-13 Italy Acceptable
2024-01-15
 2024-01-16
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-02-08 Italy Acceptable
2024-01-15
 2024-02-08
3 SUBSTANTIAL MODIFICATION SM-1 2024-03-25 Italy Acceptable
2024-06-26
 2024-06-27
4 NON SUBSTANTIAL MODIFICATION NSM-2 2024-08-05 Italy Acceptable
2024-06-26
 2024-08-05
5 SUBSTANTIAL MODIFICATION SM-2 2024-10-14 Italy Acceptable
2025-02-03
 2025-02-04
6 NON SUBSTANTIAL MODIFICATION NSM-3 2025-02-13 Acceptable
2025-02-03
 2025-02-13
7 NON SUBSTANTIAL MODIFICATION NSM-4 2025-02-17 Italy Acceptable
2025-02-03
 2025-02-17
8 SUBSTANTIAL MODIFICATION SM-3 2025-03-04 Italy Acceptable
2025-06-10
 2025-06-10
9 SUBSTANTIAL MODIFICATION SM-4 2025-07-09 Italy Acceptable
2025-10-13
 2025-10-14
10 NON SUBSTANTIAL MODIFICATION NSM-5 2025-10-27 Italy Acceptable
2025-10-13
 2025-10-27
11 NON SUBSTANTIAL MODIFICATION NSM-6 2025-10-28 Acceptable
2025-10-13
 2025-10-28
12 SUBSTANTIAL MODIFICATION SM-5 2025-11-11 Italy Acceptable 2025-12-05
13 SUBSTANTIAL MODIFICATION SM-6 2025-12-15 Acceptable 2026-01-13
14 NON SUBSTANTIAL MODIFICATION NSM-7 2026-01-28 Acceptable 2026-01-28
15 NON SUBSTANTIAL MODIFICATION NSM-8 2026-03-02 Italy Acceptable 2026-03-02
16 NON SUBSTANTIAL MODIFICATION NSM-9 2026-03-10 Acceptable 2026-03-10
17 NON SUBSTANTIAL MODIFICATION NSM-10 2026-05-06 Italy Acceptable 2026-05-06

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