A Randomised, Double-Blind, Phase III Study of AZD9833 plus Palbociclib versus Anastrozole plus Palbociclib in Patients with ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease.

Start 11 May 2021 · Status Ongoing, recruitment ended · 13 EU/EEA countries · 95 sites · Protocol D8532C00001

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruitment ended

Participants planned 1,321

Countries 13

Sites 95

Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

To demonstrate superiority of AZD9833 plus palbociclib relative to anastrozole plus palbociclib by assessment of PFS.

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: 11 May 2021 → ongoing
Decision date (initial): 2024-03-27
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: AstraZeneca AB, Sweden

External identifiers

EU CT number: 2023-503995-26-00
EudraCT number: 2020-002276-12
ClinicalTrials.gov: NCT04711252

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Therapy, Efficacy, Pharmacogenomic

To demonstrate superiority of AZD9833 plus palbociclib relative to anastrozole plus palbociclib by assessment of PFS.

Secondary objectives 4

"To demonstrate superiority of AZD9833 plus palbociclib relative to anastrozole plus palbociclib by assessment of OS and second progression free survival. "
To estimate the effectiveness of AZD9833 plus palbociclib relative to anastrozole plus palbociclib by assessment of ORR, DoR, clinical benefit rate at 24 weeks, time to chemotherapy, time to first subsequent therapy or death and time to second subsequent therapy or death.
To assess the steady state PK of AZD9833 in combination with palbociclib 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 symptoms, functioning, and health-related quality of life in participants treated with AZD9833 plus palbociclib compared with anastrozole plus palbociclib using the EORTC QLQ-C30 and EORTC QLQBR45 questionnaires.

Conditions and MedDRA coding

Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

Regulatory references

Scientific advice from competent authorities: European Medicines Agency
Plan to share IPD: Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

Pre-/peri-menopausal women or men can be enrolled if amenable to be treated with concomitant, approved LHRH agonists for the duration of the study treatment.
De novo Stage 4 disease, or recurrence from early stage disease after at least 24 months of standard adjuvant endocrine therapy. Note that at least 12 months must have elapsed since the patient's last dose of adjuvant AI therapy without disease progression on treatment. Note that a 2-week washout period is required after the last dose of tamoxifen prior to randomisation.
Histologically or cytologically documented diagnosis of ER+, HER2- negative breast cancer based on local laboratory results.
Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
Measurable disease as defined per RECIST v.1.1 OR at least one lytic or mixed (lytic + sclerotic) bone lesion with a soft tissue component that can be assessed by CT or MRI.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Adequate organ and marrow function.
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria 10

"Previous neoadjuvant or adjuvant treatment with an AI treatment +/- CDK4/6 inhibitor with disease recurrence while on or within 12 months of completing treatment. "
Prior exposure to AZD9833, other investigational SERDs/endocrine agents or fulvestrant.
Participation in another clinical study with a study treatment or investigational medicinal device administered in the last 4 weeks prior to randomization or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
Advanced, symptomatic, visceral spread, that are at risk of lifethreatening complications in the short term and/or impending visceral crisis
Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
Any clinically important and symptomatic heart disease.
Currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, renal transplant and active bleeding 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.
Any concurrent anti-cancer treatment.
Active infection including tuberculosis, HBV and HCV.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1.

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 "
"Duration of response (DoR) assessed by the Investigator as defined by RECIST version 1.1 "
Time to second subsequent therapy (TSST)
Time to chemotherapy (TTC)
Time to first subsequent anti-cancer therapy (TFST)
Clinical benefit rate at 24 weeks (CBR24)
Plasma concentration of AZD9833 at specified timepoints
Change from baseline in EORTC QLQ-C30 and EORTC QLQ-BR45 scales

Investigational products

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

Test 14

IBRANCE 100 mg hard capsules

PRD6503927 · Product

Active substance: Palbociclib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 125 mg milligram(s)
Max total dose: 00 mg milligram(s)
Max treatment duration: 26 Month(s)
Authorisation status: Authorised
ATC code: L01EF01 — -
Marketing authorisation: EU/1/16/1147/003
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The product will be relabelled for use in clinical trials

IBRANCE 125 mg hard capsules

PRD6503996 · Product

Active substance: Palbociclib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 125 mg milligram(s)
Max total dose: 00 mg milligram(s)
Max treatment duration: 26 Month(s)
Authorisation status: Authorised
ATC code: L01EF01 — -
Marketing authorisation: EU/1/16/1147/005
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The product will be relabelled for use in clinical trials

IBRANCE 125 mg hard capsules

PRD6503998 · Product

Active substance: Palbociclib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 125 mg milligram(s)
Max total dose: 00 mg milligram(s)
Max treatment duration: 26 Month(s)
Authorisation status: Authorised
ATC code: L01EF01 — -
Marketing authorisation: EU/1/16/1147/009
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: 00 mg milligram(s)
Max treatment duration: 26 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 125 mg hard capsules

PRD6503994 · Product

Active substance: Palbociclib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 125 mg milligram(s)
Max total dose: 00 mg milligram(s)
Max treatment duration: 26 Month(s)
Authorisation status: Authorised
ATC code: L01EF01 — -
Marketing authorisation: EU/1/16/1147/006
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 hard capsules

PRD6503993 · Product

Active substance: Palbociclib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 125 mg milligram(s)
Max total dose: 00 mg milligram(s)
Max treatment duration: 26 Month(s)
Authorisation status: Authorised
ATC code: L01EF01 — -
Marketing authorisation: EU/1/16/1147/008
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 hard capsules

PRD6503929 · Product

Active substance: Palbociclib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 125 mg milligram(s)
Max total dose: 00 mg milligram(s)
Max treatment duration: 26 Month(s)
Authorisation status: Authorised
ATC code: L01EF01 — -
Marketing authorisation: EU/1/16/1147/001
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The product will be relabelled for use in clinical trials

IBRANCE 100 mg hard capsules

PRD6503933 · Product

Active substance: Palbociclib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 125 mg milligram(s)
Max total dose: 00 mg milligram(s)
Max treatment duration: 26 Month(s)
Authorisation status: Authorised
ATC code: L01EF01 — -
Marketing authorisation: EU/1/16/1147/004
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 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: 00 mg milligram(s)
Max treatment duration: 26 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 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: 00 mg milligram(s)
Max treatment duration: 26 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

IBRANCE 75 mg hard capsules

PRD6503936 · Product

Active substance: Palbociclib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 125 mg milligram(s)
Max total dose: 00 mg milligram(s)
Max treatment duration: 26 Month(s)
Authorisation status: Authorised
ATC code: L01EF01 — -
Marketing authorisation: EU/1/16/1147/002
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 hard capsules

PRD6503939 · Product

Active substance: Palbociclib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 125 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 26 Month(s)
Authorisation status: Authorised
ATC code: L01EF01 — -
Marketing authorisation: EU/1/16/1147/007
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

Camizestrant

PRD9916833 · Product

Active substance: Camizestrant
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 75 mg milligram(s)
Max total dose: 00 mg milligram(s)
Max treatment duration: 26 Month(s)
Authorisation status: Not Authorised
MA holder: ASTRAZENECA AB
Paediatric formulation: No
Orphan designation: No

camizestrant

PRD11031811 · Product

Active substance: Camizestrant
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 75 mg milligram(s)
Max total dose: 00 mg milligram(s)
Max treatment duration: 26 Month(s)
Authorisation status: Not Authorised
MA holder: ASTRAZENECA AB
Paediatric formulation: No
Orphan designation: No

Comparator 1

Arimidex® 1 mg Filmtabletten

PRD8589744 · Product

Active substance: Anastrozole
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 1 mg milligram(s)
Max total dose: 00 mg milligram(s)
Max treatment duration: 26 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 2

Placebo to match Arimidex

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

Placebo to match camizestrant

N/A · Product

Other product name: N/A
Pharmaceutical form: N/A
ATC code: N/A — N/A
Marketing authorisation: N/A
MA holder: N/A
MA country: Iceland
Paediatric formulation: No

Auxiliary 2

Leuprorelin Acetate

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: 00 mg milligram(s)
Max treatment duration: 26 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Goserelin Acetate

SUB02400MIG · Substance

Active substance: Goserelin Acetate
Pharmaceutical form: IMPLANT IN PRE-FILLED SYRINGE
Route of administration: SUBCUTANEOUS
Max daily dose: 0.12 mg milligram(s)
Max total dose: 00 mg milligram(s)
Max treatment duration: 26 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

13 EU/EEA countries · 95 investigational sites

By country

Country	MS status	Planned subjects	Sites
Austria	Ongoing, recruitment ended	20	3
Belgium	Ongoing, recruitment ended	34	6
Bulgaria	Ongoing, recruitment ended	20	6
Czechia	Ongoing, recruitment ended	35	6
France	Ongoing, recruitment ended	42	12
Germany	Ongoing, recruitment ended	40	9
Hungary	Ongoing, recruitment ended	35	8
Italy	Ongoing, recruitment ended	55	13
Norway	Ongoing, recruitment ended	10	1
Poland	Ongoing, recruitment ended	37	6
Portugal	Ongoing, recruitment ended	60	9
Slovakia	Ongoing, recruitment ended	45	5
Spain	Ongoing, recruitment ended	66	11
Rest of world Switzerland, India, China, Russian Federation, Turkey, Chile, Mexico, Taiwan, Canada, Japan, Malaysia, United States, Korea, Republic of, United Kingdom	—	822	—

Investigational sites

Austria

3 sites · Ongoing, recruitment ended

Vorarlberger Krankenhaus-Betriebsgesellschaft mbH

Department of Internal Medicine III, Carinagasse 47, 6800, Feldkirch

SCRI CCCIT Ges.m.b.H.

University Hospital for Internal Medicine III of the PMU, Muellner Hauptstrasse 48, 5020, Salzburg

Klinik Hietzing

Department of Gynecology, Wolkersbergenstrasse 1, Hietzing, Vienna

Belgium

6 sites · Ongoing, recruitment ended

AZ Sint-Lucas & Volkskliniek

Oncology, Groenebriel 1, 9000, Gent

Institut Jules Bordet

Medical Oncology, Mijlenmeersstraat 90, 1070, Anderlecht

Centre hospitalier universitaire de Liege

Medical Oncology, Avenue De L'hopital 1, 4000, Liege

Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur

Medical Oncology, Place Louise Godin 15, 5000, Namur

Antwerp University Hospital

Medical Oncology, Drie Eikenstraat 655, 2650, Edegem

UZ Leuven

Gynecological oncology, Herestraat 49, 3000, Leuven

Bulgaria

6 sites · Ongoing, recruitment ended

MC Nadezhda Clinical

NA, Blaga Vest Street 3, 1330, Sofia

Complex Oncological Center - Shumen EOOD

Department of medical oncology, Ulitsa Vasil Aprilov 63, 9705, Shumen

University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD

Department of medical oncology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia

Complex Oncological Center Plovdiv EOOD

Department of Medical Oncology and oncological diseases in gastroenterology, Bulevard Aleksandir Stamboliyski 2a, 4004, Plovdiv

Multiprofessional Hospital For Active Treatment Park Hospital Ltd.

Department of medical oncology, Gerena 020 G, 4109, Branipole

Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD

Department of medical oncology, Oborishte Distr., Ul.Byalo More 8, Sofia

Czechia

6 sites · Ongoing, recruitment ended

Multiscan s.r.o.

Onkologie Nemocnice Hořovice, K Nemocnici 1106, 268 31, Horovice

Nemocnice AGEL Novy Jicin a.s.

Komplexní onkologické centrum, Purkynova 2138/16, 741 01, Novy Jicin

Fakultni Nemocnice V Motole

Onkologická klinika, V Uvalu 84/1, Motol, Prague

Fakultni Nemocnice Hradec Kralove

Klinika onkologie a radioterapie, Sokolska 581, 500 03, Novy Hradec Kralove

MEDICON Services s.r.o.

Onkocentrum Budějovická, Antala Staska 1670/80, Krc, Prague 4

Fakultni Nemocnice Kralovske Vinohrady

Onkologická klinika, Srobarova 1150/50, Vinohrady, Prague 10

France

12 sites · Ongoing, recruitment ended

Clinique Tivoli Ducos

Oncologie Médicale, 220 Rue Mandron, 33000, Bordeaux

Institut Gustave Roussy

Oncologie Médicale, 114 Rue Edouard Vaillant, 94800, Villejuif

Centre Francois Baclesse

Oncologie Médicale, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5

Centre Hospitalier Regional Et Universitaire De Brest

Institut de cancérologie et d'hématologie, 5 Avenue Marechal Foch, Bp 824, Brest Cedex 2

Besancon University Hospital Center

Oncologie Médicale, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex

Medipole De Nancy

Oncologie Médicale, 2 Rue Marie Marvingt, 54100, Nancy

Clinique Victor Hugo

Oncologie Médicale, Centre De Cancerologie De La Sarthe, 64 Rue De Degre, Le Mans

Centre De Cancerologue Du Grand Montpellier

Oncologie Médicale, 25 Rue De Clementville, 34070, Montpellier

Institut Curie

Oncologie Médicale, 35 Rue Dailly, 92210, Saint-Cloud

Centre Oscar Lambret

Pôle oncologie, comité sénologique, 3 Rue Frederic Combemale, 59000, Lille

Centr Georges Francois Leclerc

Oncologie Médicale, 1 Rue Professeur Marion, 21000, Dijon

Hospices Civils De Lyon

Oncologie Médicale, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite

Germany

9 sites · Ongoing, recruitment ended

KEM I Evang. Kliniken Essen-Mitte gGmbH

Senologie / Interdisziplinäres Brustzentrum, Henricistrasse 92, Huttrop, Essen

Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR

Praxis für Interdisziplinäre Onkologie und Hämatologie, Wirthstrasse 11c, Landwasser, Freiburg Im Breisgau

Klinikum rechts der Isar der TU Muenchen AöR

Klinik für Frauenheilkunde, Ismaninger Strasse 22, Au-Haidhausen, Munich

St. Franziskus-Hospital GmbH

Klinik für Brusterkrankungen, Hohenzollernring 70, 48145, Muenster

Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

Brustzentrum Rhein-Ruhr Servicegesellschaft mbH, Ludwig-Weber-Strasse 15, Stadtmitte, Moenchengladbach

MVZ Onkologie Velbert GbR

Gemeinschaftspraxis Dres. Naser Kalhori Arnd Nusch Werner Langer, Friedrichstrasse 311, Mitte, Velbert

Staedtisches Klinikum Dessau

Frauenheilkunde und Geburtshilfe, Auenweg 38, Alten, Dessau-Rosslau

Universitaetsklinikum Regensburg AöR

Klinik für Frauenheilkunde und Geburtshilfe, Landshuter Strasse 65, Kasernenviertel, Regensburg

HELIOS Klinikum Berlin-Buch GmbH

Brustzentrum, Schwanebecker Chaussee 50, Buch, Berlin

Hungary

8 sites · Ongoing, recruitment ended

Tolna Varmegyei Balassa Janos Korhaz

Onkologiai Osztaly, Beri Balogh Adam Utca 5-7, 7100, Szekszard

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz

Onkoradiologiai Osztaly, Szent Istvan Utca 68, 4400, Nyiregyhaza

Semmelweis University

Belgyogyaszati es Hematologiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

Onkoradiologiai Osztaly, Vasvari Pal Utca 2-4, 9024, Gyor

Zala Varmegyei Szent Rafael Korhaz

Onkologiai Osztaly, Zrinyi Miklos Utca 1, 8900, Zalaegerszeg

Orszagos Onkologiai Intezet

Mellkasi es Hasuregi Daganatok, Klinikai Farmakologiai Osztaly, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII

Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz

Klinikai Onkologiai és Sugarterapias Centrum, Szentpeteri Kapu 72-76, 3526, Miskolc

Central Hospital Of Northern Pest Military Hospital

Onkologiai Osztaly, Podmaniczky Utca 109, 1062, Budapest VI

Italy

13 sites · Ongoing, recruitment ended

Azienda Ospedaliero Universitaria Parma

Medical Oncology Unit, Viale Antonio Gramsci 14, 43126, Parma

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Department of Medical Oncology, " Piazza Oms 1", 24127, Bergamo

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Department of Oncology, Viale Del Policlinico 155, 00161, Rome

Azienda Ospedaliera Universitaria Federico II Di Napoli

Clinical Medicine and Surgery, Via Sergio Pansini 5, 80131, Naples

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Department Corp-S care and research of oncology pathways in the Thoracic District, Via Mariano Semmola 52, 80131, Naples

Istituto Oncologico Veneto

Operating Unit of Medical Oncology 2, Via Gattamelata 64, 35128, Padova

Azienda Ospedaliero Universitaria Di Modena

Department of Medical Oncology, Largo Del Pozzo 71, 41124, Modena

Azienda USL Toscana Centro

Department of Medical Oncology, Via Suor Niccolina Infermiera 20/22, 59100, Prato

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Division of Oncology, Corso Giuseppe Mazzini 18, 28100, Novara

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Department of Medical Oncology, Largo Francesco Vito 1, 00168, Rome

European Institute Of Oncology S.r.l.

Division of Medical Senology, Via Giuseppe Ripamonti 435, 20141, Milan

Careggi University Hospital

Department of oncological Radiotherapy, Largo Giovanni Alessandro Brambilla 3, 50134, Florence

Humanitas Research Hospital

U.O Oncology and Ematology, Via Alessandro Manzoni 56, 20089, Rozzano

Norway

1 site · Ongoing, recruitment ended

Vestre Viken HF

Onkologisk Poliklinikk, Groenland 32, 3045, Drammen

Poland

6 sites · Ongoing, recruitment ended

I Przychodnia Lekarska Komed Roman Karaszewski II Osrodek Badan Klinicznych III

NA, Ul. Wojska Polskiego 6, 62-500, Konin

Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie

Medical Oncology, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin

Szpitale Pomorskie Sp. z o.o.

Medical Oncology, Ul. Powstania Styczniowego 1, 81-519, Gdynia

Instytut Msf Sp. z o.o.

Medical Oncology, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz

Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli

Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Dziennej, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin

Pratia S.A.

N/A, Ul. Gryfinska 1, 60-192, Poznan

Portugal

9 sites · Ongoing, recruitment ended

Hospital De Loures EPE

Oncology Department, Avenida Carlos Teixeira 3, 2674-514, Loures

Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.

Medical Oncology Department, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia

Hospital Cuf Descobertas S.A.

Oncology Department, Rua Mario Botas 1, 1998-018, 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

CCAB Centro Clinico Academico Braga Associacao

Oncology Department, Lugar De Sete Fontes S Victor, 4710-243, Braga

Centro Hospitalar Universitario De Santo Antonio E.P.E.

Oncology Department, Largo Professor Abel Salazar, 4050-011, Porto

Hospital Da Senhora Da Oliveira Guimaraes E.P.E.

Medical Oncology Department, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes

Slovakia

5 sites · Ongoing, recruitment ended

Narodny Onkologicky Ustav

Clinic of clinical oncology, Klenova 1, Nove Mesto, Bratislava

AGEL Mammacentrum Sv. Agaty a.s.

II. Oncological outpatient care, Tibora Andrasovana 46, 974 01, Banska Bystrica

Fakultna Nemocnica Trencín

Oncological clinic, Legionarska 28, 911 01, Trencin

Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov

Outpatient care of clinical oncology, Jana Holleho 5898/14, 080 01, Presov

Onkologicky Ustav Sv Alzbety s.r.o.

Outpatient care of clinical oncology, Heydukova 10, Stare Mesto, Bratislava

Spain

11 sites · Ongoing, recruitment ended

Hospital Universitari Vall D Hebron

Oncology department, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona

Hospital Universitario Regional De Malaga

Oncology department, Avenida De Carlos De Haya Sn, 29010, Malaga

University Hospital Virgen Del Rocio S.L.

Oncology department, Avenida De Manuel Siurot S/n, 41013, Sevilla

Hospital Universitario De Jaen

Oncology department, Avenida Del Ejercito Espanol 10, 23007, Jaen

Hospital Universitario Marques De Valdecilla

Oncology department, Avenida Valdecilla Sn, 39008, Santander

Hospital Universitario La Paz

Oncology department, Paseo Castellana 261, 28046, Madrid

Hospital Clinico San Carlos

Oncology department, Calle Del Profesor Martin Lagos Sn, 28040, Madrid

Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida

Oncology department, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida

Hospital Arnau De Vilanova De Valencia

Oncology department, Calle De San Clemente 12, 46015, Valencia

Institut Catala D'oncologia

Oncology department, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat

Clinica Universidad De Navarra

Oncology department, Calle Marquesado De Santa Marta 1, 28027, Madrid

Country notifications

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

Country	Trial start	Recruitment start	Recruitment end
Austria	2021-06-29	2021-07-16	2023-04-20
Belgium	2021-05-20	2021-06-08	2023-08-21
Bulgaria	2021-11-03	2021-11-03	2023-08-14
Czechia	2021-06-04	2021-09-02	2023-05-17
France	2021-11-18	2021-12-17	2023-11-21
Germany	2021-06-16	2021-06-28	2023-07-14
Hungary	2021-05-28	2021-07-26	2023-11-22
Italy	2021-08-05	2021-09-07	2023-10-13
Norway	2022-05-23	2023-04-03	2023-11-13
Poland	2021-05-27	2021-06-25	2023-07-14
Portugal	2021-09-16	2021-11-02	2023-11-02
Slovakia	2021-06-30	2021-10-13	2023-04-13
Spain	2021-05-11	2021-05-12	2023-11-22

Results and documents

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

Documents 79 files

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

Type	Title	Version
Protocol (for publication)	CTIS Blank document for publication	1
Protocol (for publication)	D1_Protocol 2023-503995-26_redacted	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 publication	NA
Subject information and informed consent form (for publication)	CTIS Blank document for publication	1
Subject information and informed consent form (for publication)	CTIS Blank document for publication	NA
Subject information and informed consent form (for publication)	L1 SIS and ICF_Genetic_GER_redacted	2
Subject information and informed consent form (for publication)	L1_ SIS and ICF Adults PL_Redacted	5
Subject information and informed consent form (for publication)	L1_ SIS and ICF GENETIC FR_Redacted	1.1
Subject information and informed consent form (for publication)	L1_ SIS and ICF Main Adults FR_Redacted	3
Subject information and informed consent form (for publication)	L1_ SIS and ICF Main Adults_BG_Redacted	4
Subject information and informed consent form (for publication)	L1_ SIS and ICF optional genetic PL_Redacted	3
Subject information and informed consent form (for publication)	L1_ SIS and ICF Pregnant Partners FR Redacted	2
Subject information and informed consent form (for publication)	L1_ SIS and ICF pregnant partners PL	3
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum Future SK_Redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum Optional Bio-samples SK_Redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum Personal Data and Biological Samples SK_Redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum to ICF Handling of Personal Data_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 Addendum Updated Information due to MICF_ Redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Adult HU_Redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Adult ICF_AT_redacted	6
Subject information and informed consent form (for publication)	L1_SIS and ICF Adult Participant SK_Redacted	4
Subject information and informed consent form (for publication)	L1_SIS and ICF Adult Subject_redacted	4
Subject information and informed consent form (for publication)	L1_SIS and ICF Adults_Redacted	4
Subject information and informed consent form (for publication)	L1_SIS and ICF Biological Sample Addendum_Redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Genetic Addendum _Redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Genetic SK_Redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Optional future genetic HU_Redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Optional genetic HU_Redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Optional Genetic Research_redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant Participant PO	0.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant Partner	4
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant partners HU	1
Subject information and informed consent form (for publication)	L1_SIS and ICF PT Adult Sub_Redacted	5.1
Subject information and informed consent form (for publication)	L1_SIS and ICF PT Genetic_Redacted	3.1
Subject information and informed consent form (for publication)	L1_SIS and ICF PT Pregnant Partner_PO	4.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Adult Subject ICF_Redacted	5
Subject information and informed consent form (for publication)	L1_SIS and ICF_Adult_Ger_redacted	5
Subject information and informed consent form (for publication)	L1_SIS and ICF_Future Research ICF_Redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF_Genetic BG_Redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Genetic ICF_AT_redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF_Genetic Subject ICF_Redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partners ICF	4
Subject information and informed consent form (for publication)	L2 Country specific List of sites _AT	2
Subject information and informed consent form (for publication)	L2_Country specific List of sites _AU	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC palbociclib	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Palbociclib	5
Synopsis of the protocol (for publication)	D1_Protocol Lay Language Synopsis 2023-503995-26_redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Lay Language Synopsis BG 2023-503995-26_Redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Lay Language Synopsis ES 2023-503995-26_redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Lay Language Synopsis FR 2023-503995-26_redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Lay Language Synopsis HU 2023-503995-26_redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Lay Language Synopsis IT 2023-503995-26_redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Lay Language Synopsis PL 2023-503995-26_redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Lay Language synopsis PT 2023-503995-26_redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis 2023-503995-26-00 FR_ redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis 2023-503995-26-00 NL_redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis BE 2023-503995-26_Redacted Dutch	1
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis BE 2023-503995-26_Redacted French	1
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis BE 2023-503995-26_Redacted German	1
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis BG 2023-503995-26_redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis HU 2023-503995-26_redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis IT 2023-503995-26_redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis PT 2023-503995-26_redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis SK 2023-503995-26_Redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis_ AT_2023-503995-26_redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis_2023-503995-26-00_ES_Redacted	1
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis_CZ_2023-503995-26_redacted	1

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-01-31	Italy	Acceptable 2024-03-13	2024-03-13
2	SUBSTANTIAL MODIFICATION	SM-2	2024-06-14	Italy	Acceptable 2024-08-13	2024-08-14
3	NON SUBSTANTIAL MODIFICATION	NSM-1	2024-10-04		Acceptable 2024-08-13	2024-10-04
4	SUBSTANTIAL MODIFICATION	SM-3	2024-10-07		Acceptable	2024-10-14
5	SUBSTANTIAL MODIFICATION	SM-4	2024-10-10		Acceptable	2024-11-08
6	SUBSTANTIAL MODIFICATION	SM-5	2024-12-02	Italy	Acceptable 2025-03-11	2025-03-11
7	SUBSTANTIAL MODIFICATION	SM-6	2025-04-16	Italy	Acceptable	2025-05-26
8	SUBSTANTIAL MODIFICATION	SM-7	2025-04-16		Acceptable	2025-06-16
9	SUBSTANTIAL MODIFICATION	SM-9	2025-04-16		Acceptable	2025-05-13
10	SUBSTANTIAL MODIFICATION	SM-8	2025-04-18		Acceptable	2025-05-06
11	SUBSTANTIAL MODIFICATION	SM-10	2025-04-18			2025-06-02
12	SUBSTANTIAL MODIFICATION	SM-11	2025-04-18		Acceptable	2025-05-27
13	NON SUBSTANTIAL MODIFICATION	NSM-2	2025-06-18		Acceptable	2025-06-18
14	SUBSTANTIAL MODIFICATION	SM-12	2025-07-11	Italy	Acceptable 2025-10-02	2025-10-02
15	SUBSTANTIAL MODIFICATION	SM-13	2025-11-13		Acceptable	2025-12-15
16	SUBSTANTIAL MODIFICATION	SM-14	2026-01-22	Italy	Acceptable 2026-04-28	2026-04-28

A Randomised, Double-Blind, Phase III Study of AZD9833 plus Palbociclib versus Anastrozole plus Palbociclib in Patients with ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease.

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 4

Conditions and MedDRA coding

Regulatory references

Eligibility criteria

Inclusion criteria 8

Exclusion criteria 10

Endpoints

Primary endpoints 1

Secondary endpoints 10

Investigational products

Test 14

Comparator 1

Placebo 2

Auxiliary 2

Sponsors and contacts

AstraZeneca AB

Scientific contact point

Public contact point

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 79 files

Application history

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