Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
300
Countries
12
Sites
110
Estrogen Receptor-Positive, HER-2 negative Advanced Breast Cancer
To demonstrate superiority of AZD9833 plus CDK4/6 inhibitor relative to AI plus CDK4/6 inhibitor by assessment of PFS in the FAS
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Sep 2021 → ongoing
- Decision date (initial)
- 2024-10-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503990-39-00
- EudraCT number
- 2021-000546-17
- ClinicalTrials.gov
- NCT04964934
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacokinetic, Safety, Pharmacodynamic, Efficacy
To demonstrate superiority of AZD9833 plus CDK4/6 inhibitor relative to AI plus CDK4/6 inhibitor by assessment of PFS in the FAS
Secondary objectives 7
- "To demonstrate superiority of AZD9833 plus CDK4/6 inhibitor relative to AI plus CDK4/6 inhibitor by assessment of PFS2 and OS in the FAS "
- To assess breast and arm symptoms, pain, and physical functioning in participants treated with AZD9833 plus CDK4/6 inhibitor relative to AI plus CDK4/6 inhibitor
- To assess the steady state PK of AZD9833 in combination with Palbociclib, Abemaciclib or Ribociclib in all participants who receive at least one dose of AZD9833 per the protocol, for whom there are at least one reportable PK concentration.
- To assess the safety and tolerability of AZD9833 plus CDK4/6 inhibitor relative to AI plus CDK4/6 inhibitor in participants with advanced HR+/HER2-negative BC.
- To estimate the effectiveness of AZD9833 plus CDK4/6 inhibitor relative to AI plus CDK4/6 inhibitor by assessment of chemotherapy free survival in the FAS
- To estimate the effectiveness of AZD9833 plus CDK4/6 inhibitor relative to AI plus CDK4/6 inhibitor by assessment of ORR in patients with measurable disease in the FAS
- To estimate the effectiveness of AZD9833 plus CDK4/6 inhibitor relative to AI plus CDK4/6 inhibitor by assessment of CBR24,Time to First and Second Subsequent Treatment in the FAS
Conditions and MedDRA coding
Estrogen Receptor-Positive, HER-2 negative Advanced Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10072737 | Advanced breast cancer | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent.
- Documentation of histologically confirmed diagnosis of estrogen receptor positive (ER+) /HER2- breast cancer based on local laboratory results.
- Currently on AI (letrozole or anastrozole) + CDK4/6 inhibitor ± LHRH as the initial endocrine based treatment for advanced disease
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- ESR1m detected by central testing of ctDNA
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Adequate organ and marrow function
Exclusion criteria 7
- Advanced, symptomatic, visceral spread, that are at risk of lifethreatening complications in the short term
- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
- Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
- Patient with known or family history of severe heart disease
- Previous treatment with AZD9833, investigational SERDs or fulvestrant.
- Currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
- Persistent non-haematological toxicities (CTCAE Grade > 2) caused by CDK4/6 inhibitor and/or AI treatment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression-free survival (PFS) is defined as the time from randomisation until progression per RECIST 1.1 as assessed by the investigator at the local site, or death due to any cause.
Secondary endpoints 10
- Overall survival (OS)
- Progression-free survival 2 (PFS2)
- Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1
- Chemotherapy-free survival
- Clinical benefit rate at 24 weeks (CBR24)
- Time to first subsequent anti-cancer therapy (TFST)
- Time to second subsequent therapy (TSST)
- Time to deterioration (TTD)
- Plasma concentration of AZD9833 at specified timepoints
- Change from baseline in EORTC QLQ-C30 and EORTC QLQ-BR23 scale
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 9
PRD11031811 · Product
- Active substance
- Camizestrant
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 77 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
PRD9916833 · Product
- Active substance
- Camizestrant
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 77 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
SUB180246 · Substance
- Active substance
- Ribociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 77 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be relabelled for use in clinical trials
SUB171907 · Substance
- Active substance
- Abemaciclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 77 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be relabelled for use in clinical trials
SUB171907 · Substance
- Active substance
- Abemaciclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 77 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be relabelled for use in clinical trials
SUB171907 · Substance
- Active substance
- Abemaciclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 77 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be relabelled for use in clinical trials
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
- 0 mg milligram(s)
- Max treatment duration
- 77 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
- The product will be relabelled for use in clinical trials
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
- 0 mg milligram(s)
- Max treatment duration
- 77 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
- The product will be relabelled for use in clinical trials
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
- 0 mg milligram(s)
- Max treatment duration
- 77 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
- The product will be relabelled for use in clinical trials
Comparator 2
SUB08444MIG · Substance
- Active substance
- Letrozole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 77 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- For blinding purposes in clinical trials, the tablets are over-encapsulated
PRD8589744 · Product
- Active substance
- Anastrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 77 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG03 — ANASTROZOLE
- Marketing authorisation
- 37180.00.00
- MA holder
- LABORATOIRES JUVISE PHARMACEUTICALS
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- For blinding purposes in clinical trials, a 'clinical tablet' presentation is available. ARIMIDEX (anastrozole) clinical tablets, 1 mg are identical to the commercial formulation except for tablet intagliation, clinical trials packaging and labelling and shelf life. The modification to the appearance of the commercial product (for blinding purposes) is considered not to affect the function, stability and efficacy of the comparator product.
Placebo 3
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
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
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
Auxiliary 2
SUB02900MIG · Substance
- Active substance
- Leuprorelin Acetate
- Pharmaceutical form
- POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 0.13 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 77 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02400MIG · Substance
- Active substance
- Goserelin Acetate
- Pharmaceutical form
- IMPLANT IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.13 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 77 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
12 EU/EEA countries · 110 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 5 | 6 |
| Belgium | Ongoing, recruitment ended | 2 | 2 |
| Bulgaria | Ongoing, recruitment ended | 10 | 9 |
| France | Ongoing, recruitment ended | 32 | 19 |
| Germany | Ongoing, recruitment ended | 17 | 21 |
| Hungary | Ongoing, recruitment ended | 9 | 6 |
| Italy | Ongoing, recruitment ended | 9 | 11 |
| Norway | Ended | 2 | 2 |
| Poland | Ongoing, recruitment ended | 10 | 8 |
| Portugal | Ongoing, recruitment ended | 9 | 10 |
| Slovakia | Ongoing, recruitment ended | 8 | 5 |
| Spain | Ongoing, recruitment ended | 15 | 11 |
| Rest of world
Russian Federation, Korea, Republic of, Taiwan, Canada, Turkey, Switzerland, Japan, Israel, United States, Australia, United Kingdom
|
— | 172 | — |
Investigational sites
SCRI CCCIT Ges.m.b.H.
NA, Muellner Hauptstrasse 48, 5020, Salzburg
Medical University Of Vienna
Department of General Gynecology and Gynaecological Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna
Medical University Of Graz
Gynaecology and obstetrics, Neue Stiftingtalstrasse 6, 8036, Graz
Medical University Of Graz
Breast Center, Neue Stiftingtalstrasse 6, 8010, Graz
Medizinische Universitaet Innsbruck
University Clinic for gynaecology and obstetrics, Anichstrasse 35, 6020, Innsbruck
Klinik Hietzing
Karl Landsteiner Institut for gyn. Onkology und Senology, Wolkersbergenstrasse 1, Hietzing, Vienna
CHC MontLegia
Oncology, Boulev. De Patience Et Beajonc 2, 4000, Liege
UZ Leuven
Gynecologic Oncology, Herestraat 49, 3000, Leuven
Acibadem City Clinic Tokuda University Hospital EAD
Department of medical oncology, Bulevard Nikola Yonkov Vaptsarov 51b, 1407, Sofiya
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Department of medical oncology, Georgi Benkovski Street 100, 4500, Panagyurishte
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department of medical oncology, Oborishte Distr., Ul.Byalo More 8, Sofia
MBAL Serdika Ltd.
Department of medical oncology, Ulitsa DamyanGruev 6, 1303, Sofiya
Specialized Hospital For Active Treatment Of Oncology Haskovo EOOD
Department of medical oncology, Bulevard Siedinenie 49, 6304, Haskovo
Complex Oncological Center Plovdiv EOOD
Department of medical oncology and oncological diseases in gastroenterology, Bulevard Aleksandir Stamboliyski 2a, 4004, Plovdiv
Medical Centre Nadezhda Clinical EOOD
Medical Oncology Office, Blaga Vest Str 3, 1303, Sofia
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Clinic of medical oncology, Pierre Curie Street 2, 5804, Pleven
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department of medical oncology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
Hopitaux Prives De Metz
Oncologie, Parvis Schuman Rue Champs Montoy, Rue Pre Montois, Vantoux
Institut Curie
NA, 35 Rue Dailly, 92210, Saint-Cloud
Centre Hospitalier Regional Universitaire De Tours
" Service Oncologie Médicale", 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Centre Henri Becquerel
Oncologie Médicale, 1 Rue D Amiens, 76000, Rouen
Centre Hospitalier Regional Et Universitaire De Brest
Institut Cancérologie et d'imagerie, Boulevard Tanguy Prigent, 29200, Brest
Institut De Cancerologie De Lorraine
" Département d'oncologie médicale", 6 Avenue De Bourgogne, Cs 30519, Vandoeuvre Les Nancy Cedex
Institut Curie
" Oncologie Médicale", 26 Rue D Ulm, 75005, Paris
Institut Paoli Calmettes
Oncologie Médicale, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Pole Sante Republique
Oncologie Médicale - Hématologie, 105 Avenue De La Republique, 63050, Clermont Ferrand Cedex 2
Centr Georges Francois Leclerc
NA, 1 Rue Professeur Marion, 21000, Dijon
Centre Hospitalier Universitaire De Nantes
Oncologie, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Institut Sainte Catherine
NA, 250 Chemin De Baigne Pieds, 84000, Avignon
Groupe Hospitalier Bretagne Sud
Oncologie Médicale, 5 Avenue Etienne Francois De Choiseul, 56100, Lorient
Centre Leon Berard
Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Et Universitaire De Limoges
Oncologie Médicale, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Institut Universitaire Du Cancer Toulouse-Oncopole
Oncologie Médicale, 1 Avenue Irene Joliot Curie, France, Toulouse
Centre Hospitalier Universitaire De Nimes
" Institut de Cancérologie du Gard", Place Du Professeur Robert Debre, 30029, Nimes Cedex 9
Centre Hospitalier Annecy Genevois
Site d'Annecy, 1 Avenue De L Hopital, Bp 90074 Epagny Metz Tessy, Pringy Cedex
Institut Gustave Roussy
Département d'Oncologie Médicale, 114 Rue Edouard Vaillant, 94800, Villejuif
MVZ Dr. Hancken Kliniken Stade
NA, Harsefelder Str. 8, 21680, Stade
KEM I Evang. Kliniken Essen-Mitte gGmbH
Senologie/Interdisziplinäres Brustzentrum, Henricistrasse 92, Huttrop, Essen
Universität Regensburg
Frauenheilkunde und Geburtshilfe, Landshuter Str. 65, 93053, Regensburg
Universitaetsklinikum Tuebingen AöR
Frauenklinik, Calwerstrasse 7, Innenstadt, Tuebingen
Universitaetsklinikum Augsburg
Frauenklinik, Stenglinstrasse 2, Kriegshaber, Augsburg
Rotkreuzklinikum Muenchen gGmbH
Gynäkologie, Taxisstrasse 3, Neuhausen-Nymphenburg, Munich
St. Vincenz-Krankenhaus GmbH
Frauen- und Kinderklinik, Husener Strasse 81, Kernstadt, Paderborn
"InVO- Institut für Versorgungsforschung in der Onkologie GbR"
NA, Neversstraße 5, 56068, Koblenz
Klinikum Chemnitz gGmbH
Frauenheilkunde und Geburtshilfe, Flemmingstrasse 2, Altendorf, Chemnitz
Studienzentrum Onkologie Ravensburg GmbH
NA, Elisabethenstrasse 19, 88212, Ravensburg
Universitaetsklinikum Ulm AöR
Frauenheilkunde und Geburtshilfe, Prittwitzstrasse 43, Mitte, Ulm
MVZ am Klinikum Aschaffenburg
Onkologie, Am Hasenkopf 1, 63739, Aschaffenburg
Universitaetsklinikum Erlangen AöR
Frauenklinik, Maximiliansplatz 2, Innenstadt, Erlangen
Klinikverbund Allgaeu gGmbH
Frauenheilkunde und Geburtshilfe, Robert Weixler Strasse 50, 87439, Kempten (Allgau)
Anregiomed Klinikum Ansbach
Klinik für Gynäkologie und Geburtshilfe, Escherichstraße 1, 91522, Ansbach
Technische Universitaet Dresden
Klinik für Frauenheilkunde und Geburtshilfe, Fetscherstrasse 74, Johannstadt-Nord, Dresden
MVZ für Onkologie und Hämatologie
NA, Friedrichstraße 311, 42551, Velbert
Gynaekologisches Zentrum Bonn
NA, Friedensplatz 16, Zentrum, Bonn
UMM Universitätsmedizin Mannheim
Frauenklinik, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
NA, Wirthstrasse 11c, Landwasser, Freiburg Im Breisgau
Universitaetsklinikum Leipzig AöR
Poliklinik für Frauenheilkunde, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Onkológiai Osztály, Toszegi Ut 21, 5000, Szolnok
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Klinikai Onkológiai és Sugárterápiás Centrum, Szentpeteri Kapu 72-76, 3526, Miskolc
Zala Varmegyei Szent Rafael Korhaz
Onkológiai Osztály, Zrinyi Miklos Utca 1, 8900, Zalaegerszeg
Tolna Varmegyei Balassa Janos Korhaz
Onkológiai Osztály, Beri Balogh Adam Utca 5-7, 7100, Szekszard
Central Hospital Of Northern Pest Military Hospital
Onkológiai Osztály, Podmaniczky Utca 109, 1062, Budapest VI
Orszagos Onkologiai Intezet
Mellkasi és Hasüregi Daganatok és Klinikai Farmakológiai Osztály, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Ospedale San Raffaele S.r.l.
Oncologia Medica, Via Olgettina 60, 20132, Milan
ASST Papa Giovanni XXIII
Oncologia Medica, P.zza Oms, 1, Bergamo
A. O. U. Policlinico Sant'Orsola Malpighi
SSD Oncologia Medica, Via Pietro Albertoni, 15, Bologna
Humanitas Istituto Clinico Catanese S.p.A.
U.O. Chirurgia Oncologica, Strada Provinciale 54 Contrada Cubba 11, 95045, Misterbianco
Azienda Ospedaliero Universitaria Careggi
Oncologia, Largo Brambilla, 3, Firenze
Istituto Clinico Humanitas
Oncologia Medica ed Ematologia, Via Manzoni 56, 20089, Rozzano
Istituto Oncologico Veneto
UOC Oncologia Medica 2, Via Gattamelata 64, 35128, Padova
Istituto Europeo Di Oncologia S.r.l.
Divisione di Senologia Medica, Via Giuseppe Ripamonti 435, 20141, Milan
Istituto Nazionale Tumori IRCCS Pascale
Dipartimento Corp-S assistenziale e di ricerca dei percorsi oncologici del Distretto Toracico, Via M. Semmola 3, 80131, Napoli
IRST Dino Amadori
Oncologia medica ed Ematologia, Via Piero Maroncelli 40, 47014, Meldola
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOSD Medicina di Precisione in Senologia, Largo Francesco Vito 1, 00168, Rome
Avdeling for kreftbehandling
Avdeling for kreftbehandling, Bygg A, etasje U1. Ullernchausseen 70, Oslo
Vestre Viken HF
Onkologisk Poliklinikk, Groenland 32, 3045, Drammen
Szpitale Pomorskie Sp. z o.o.
NA, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii i Oddzial Kliniczny Radioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Centrum Medyczne Medyk Sp. z o.o. S.K.
NA, Al. Tadeusza Rejtana 53, 35-326, Rzeszow
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.
NA, Ul. Jana Pawla II 35, 97-200, Tomaszow Mazowiecki
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
NA, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Instytut Msf Sp. z o.o.
NA, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddzial Dzienny Chemioterapii, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Med Polonia Sp. z o.o.
NA, Obornicka 262, 60-693, Poznan
Hospital De Loures EPE
Oncology Department, Avenida Carlos Teixeira 3, 2674-514, Loures
Unidade Local De Saude Do Alto Ave E.P.E.
Medical Oncology Department, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Unidade Local de Saude de Sao Joao E.P.E.
Oncology Department, Alameda Professor Hernani Monteiro, 4200-319, Porto
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Medical Oncology Department, Estrada Forte Do Alto Duque, 1449-005, Lisbon
Champalimaud Clinical Centre
Breast Unit, Avenida Brasilia S/n, 1400-038, Lisbon
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Oncology Department, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Hospital Da Luz S.A.
Oncology Department, Avenida Lusiada 100, 1500-650, Lisbon
Unidade Local De Saude De Gaia/Espinho E.P.E.
Medical Oncology Department, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Unidade Local De Saude De Santa Maria E.P.E.
Medical Oncology Department, Avenida Professor Egas Moniz, 1649-035, Lisbon
Unidade Local De Saude De Santo Antonio E.P.E.
"Oncology Department ", Largo Professor Abel Salazar, 4050-011, Porto
Nemocnica s poliklinikou Stefana Kukuru Michalovce a.s.
Oncology Department, Spitalska 2, 071 01, Michalovce
Nemocnica Na Okraji Mesta N.O.
Clinical Oncology Department, Nova Nemocnica 511, 958 01, Partizanske
Narodny Onkologicky Ustav
Clinic of Clinical Oncology, Klenova 1, Nove Mesto, Bratislava
Vychodoslovensky Onkologicky Ustav a.s.
Department of Clinical Oncology, Rastislavova 43, Juh, Kosice
AGEL Mammacentrum Sv. Agaty a.s.
II. Oncological outpatient care, Tibora Andrasovana 46, 974 01, Banska Bystrica
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital General Universitario De Valencia
Oncology, Avenida Del Tres Cruces 2, 46014, Valencia
Consorci Sanitari Integral
Oncology, Avinguda De Josep Molins 29-41, 08906, L'hospitalet De Llobregat
Hospital Universitario Virgen del Rocio
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital General Universitario Morales Meseguer
Oncology, Avenida Del Marques De Los Velez S/n, 30008, Murcia
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
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 | 2022-05-10 | 2022-05-12 | 2024-07-22 | ||
| Belgium | 2023-01-09 | 2023-01-16 | 2024-04-08 | ||
| Bulgaria | 2021-10-27 | 2021-11-12 | 2024-02-21 | ||
| France | 2022-01-12 | 2022-01-18 | 2024-07-25 | ||
| Germany | 2021-12-12 | 2022-03-08 | 2024-07-25 | ||
| Hungary | 2021-09-30 | 2021-10-12 | 2024-06-12 | ||
| Italy | 2021-11-15 | 2022-02-02 | 2024-08-12 | ||
| Norway | 2023-04-26 | 2024-12-14 | 2023-05-15 | 2023-12-06 | |
| Poland | 2021-10-28 | 2021-11-08 | 2024-09-11 | ||
| Portugal | 2022-04-29 | 2022-05-26 | 2024-09-20 | ||
| Slovakia | 2023-01-27 | 2023-02-08 | 2024-06-25 | ||
| Spain | 2021-11-17 | 2021-12-21 | 2024-07-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 99 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-503990-39 _redacted | 5 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | 1 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | 1 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | 1 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | 1 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | 1 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | 1 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | 1 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | 1 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | 1 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | 1 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | 1 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | 1 |
| Subject information and informed consent form (for publication) | CTIS Blank Document for Transition Trials | NA |
| Subject information and informed consent form (for publication) | CTIS Blank Document for Transition Trials | NA |
| Subject information and informed consent form (for publication) | CTIS Blank Document for Transition Trials | NA |
| Subject information and informed consent form (for publication) | CTIS Blank Document for Transition Trials | NA |
| Subject information and informed consent form (for publication) | CTIS Blank Document for Transition Trials | NA |
| Subject information and informed consent form (for publication) | CTIS Blank Document for Transition Trials | NA |
| Subject information and informed consent form (for publication) | CTIS Blank Document for Transition Trials | NA |
| Subject information and informed consent form (for publication) | CTIS Blank Document for Transition Trials | NA |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adult part I PL_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adult part II PL_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF genetic subject PL_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main 1_FR_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main 2_FR_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Genetic Research_FR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 1 Addendum Future Research SK_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 1 Addendum Personal Data SK_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 1 Adult Participant SK_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2 Addendum Future Research SK_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2 Addendum Personal Data SK_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2 Adult Participant SK_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2 Optional Bio-Samples Addendum SK_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum UOOU Address Change SK | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult ICF1_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult ICF2_redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult Subject Addendum SK | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_genetic_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_ICF1_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_ICF2_English_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_ICF2_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF First screening optional future HU_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research SK_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main first screening step 1 HU_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main step 2 HU_redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Genetic HU_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner HU_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Step 2 optional future HU_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject 1_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject 1_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject 2_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject 2_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject DCI1_ES_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject DCI2 Annex_ES_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject DCI2_ES_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult subject ICF1_IT_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult subject ICF2_IT_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject ICF2_redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic subject ICF_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic Subject_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Step 1_BE_Dutch_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Step 1_BE_English_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Step 1_BE_French_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Step 2_BE_Dutch_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Step 2_BE_English_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Step 2_BE_French_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NO_Future Research_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NO_ICF1_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetic Research Information_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetic Research Information_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional procedures ICF1_IT_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional procedures ICF2_IT_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_Site List AT | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Participation Card_HU_redacted | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Abemaciclib | 5 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis_Lay Language_EN_2023-503990-39__redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Language Synopsis_SK_2023-503990-39_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Language_ES_2023-503990-39-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Languages_BE_German 2023-503990-39-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Languages_FR_2023-503990-39-00_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT_2023-503990-39_Redacted | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2023-503990-39_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Language BG_2023-503990-39_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Language Synopsis_2023-503990-39-00_IT_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay Language_PL_2023-503990-39-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Languages_BE_Dutch 2023-503990-39-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Languages_BE_French 2023-503990-39-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Languages_HU_2023-503990-39-00_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Languages_NO_2023-503990-39_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Languages_PT_2023-503990-39-00_redacted | 1.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Scientific BG_2023-503990-39_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SS_2023-503990-39-00_HU_redacted | 4 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-26 | Italy | Acceptable 2024-09-10
|
2024-09-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-21 | Italy | Acceptable 2025-03-11
|
2025-03-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-16 | Acceptable | 2025-06-29 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-16 | Acceptable | 2025-04-30 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-18 | Acceptable | 2025-06-27 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-30 | Acceptable | 2025-06-12 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-07 | Acceptable | 2025-07-07 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-17 | Italy | Acceptable 2025-09-19
|
2025-09-22 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-01-22 | Italy | Acceptable 2026-04-21
|
2026-04-21 |