Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
367
Countries
4
Sites
41
Estrogen Receptor (ER)-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer previously treated with a CDK4/6 inhibitor and endocrine therapy
To evaluate the efficacy of giredestrant plus everolimus compared with the physician’s choice of endocrine therapy plus everolimus in the estrogen receptor 1 mutant subpopulation (ESR1m subpopulation) and in the intent-to-treat (ITT) population on the basis of investigator-assessed progression-free survival (PFS)
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Oct 2023 → ongoing
- Decision date (initial)
- 2024-06-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Genentech Inc.
External identifiers
- EU CT number
- 2023-506821-12-00
- EudraCT number
- 2022-000199-20
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Safety
To evaluate the efficacy of giredestrant plus everolimus compared with the physician’s choice of endocrine therapy plus everolimus in the estrogen receptor 1 mutant subpopulation (ESR1m subpopulation) and in the intent-to-treat (ITT) population on the basis of investigator-assessed progression-free survival (PFS)
Secondary objectives 3
- To evaluate the efficacy of giredestrant plus everolimus compared with the physician’s choice of endocrine therapy plus everolimus in the ESR1m subpopulation and the ITT population on the basis of overall survival (OS), objective response rate (ORR), duration of response (DOR), clinical benefit rate (CBR), time to confirmed deterioration (TTCD) in pain severity, TTCD in pain presence and interference, TTCD in Physical Functioning (PF), TTCD in Role Functioning (RF) and TTCD in health-related quality of life (HRQoL)
- To evaluate the safety of giredestrant plus everolimus compared with the physician’s choice of endocrine therapy plus everolimus
- To characterize the giredestrant pharmacokinetic (PK) profile when given in combination with everolimus
Conditions and MedDRA coding
Estrogen Receptor (ER)-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer previously treated with a CDK4/6 inhibitor and endocrine therapy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10027475 | Metastatic breast cancer | 10029104 |
| 23.0 | LLT | 10070575 | Estrogen receptor positive breast cancer | 10029104 |
| 21.1 | LLT | 10072740 | Locally advanced breast cancer | 10029104 |
| 28.0 | PT | 10085481 | Hormone receptor positive HER2 negative breast cancer | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Overall Design This study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician’s choice of endocrine therapy plus everolimus in patients with estrogen-receptor positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.
|
Randomised Controlled | None | A: Giredestrant + Everolimus B: Physician’s Choice of Endocrine Therapy + Everolimus |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Locally advanced unresectable or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
- Documented estrogen receptor-positive (ER+) tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society for Medical Oncology (ESMO) guidelines, assessed locally and defined as >= 1% of tumor cells stained positive based on the most recent tumor biopsy (or archived tumor sample)
- Documented human epidermal growth factor receptor 2 (HER2)-negative tumor assessed locally
- Ability to provide a blood sample for circulating-tumor deoxyribonucleic acid (ctDNA) ESR1 mutation status determination by central testing prior to study treatment randomization
- Measurable disease as defined per RECIST v.1.1 or evaluable bone metastases which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
- Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade ≤ 1
Exclusion criteria 6
- Prior treatment with another oral selective estrogen receptor degrader (SERD), proteolysis targeting chimera (PROTAC), complete estrogen receptor antagonist (CERAN), novel oral selective estrogen receptor modulator (SERM) or everolimus in any setting. Prior fulvestrant is allowed if treatment was terminated at least 28 days prior to randomization. Prior treatment with tamoxifen is allowed.
- Progression on more than 2 prior lines of systemic endocrine therapy in the locally advanced unresectable or metastatic breast cancer setting
- Treatment with strong Cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 14 days or 5 drug elimination half-lives prior to randomization
- History of any other malignancy other than breast cancer within 5 years prior to screening except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, Stage I endometrial cancer or other non-breast cancers at very low risk of recurrence
- Patients known to be positive for human immunodeficiency viruses (HIV) are excluded if they meet any of the following criteria: - CD4+ T-cell count of < 350 cells/µL - Detectable HIV viral load - History of an opportunistic infection within the past 12 months - On stable antiretroviral therapy for < 4 weeks
- Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery including gastric resection, potentially affecting enteral absorption, or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- 1. PFS in the ESR1m subpopulation determined by the investigator
- 2. PFS in the ITT population, determined by the investigator, PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
Secondary endpoints 13
- 1. OS after randomization, defined as the time from randomization to death from any cause
- 2.ORR, defined as the proportion of patients 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
- 3.DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
- 4.CBR, defined as the proportion of patients with stable disease for >= 24 weeks or a CR or PR on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1
- 5.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 Brief Pain Inventory-Short Form (BPI-SF) held for two consecutive time points, or a ≥2-point increase followed by death attributable to cancer progression within 28 days from the last assessment
- 6.TTCD in pain presence and interference after randomization, defined as the time from randomization to the first documentation of >= 10-point increase in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 Questionnaire (QLQ-C30) linearly transformed pain scale score held for two consecutive time points, or a >=10-point increase followed by death attributable to cancer progression within 28 days from the last assessment
- 7.TTCD in PF after randomization, defined as the time from randomization to the first documentation of >= 10-point decrease from baseline in the EORTC QLQ-C30 linearly transformed PF scale score held for two consecutive time points, or a >= 10-point decrease followed by death attributable to cancer progression within 28 days from the last assessment
- 8.TTCD in RF after randomization, defined as the time from randomization to the first documentation of >= 10-point decrease from baseline in the EORTC QLQ-C30 linearly transformed RF scale score held for two consecutive time points, or a >= 10-point decrease followed by death attributable to cancer progression within 28 days from the last assessment
- 9.TTCD in HRQoL after randomization, defined as the time from randomization to the first documentation of >= 10-point decrease from baseline in the EORTC QLQ-C30 linearly transformed GHS/QoL scale score held for two consecutive time points, or a >= 10-point decrease followed by death attributable to cancer progression within 28 days from the last assessment
- 10.Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0
- 11.Change from baseline in targeted vital signs
- 12.Change from baseline in targeted clinical laboratory test results
- 13. Plasma concentration of giredestrant at specified timepoints
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 13
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
- 37.47 g gram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD4008057 · Product
- Active substance
- Everolimus
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12.49 g gram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EG02 — -
- Marketing authorisation
- EU/1/09/538/009
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Everolimus Zentiva 10 mg Tabletten
PRD6779056 · Product
- Active substance
- Everolimus
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12.49 g gram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EG02 — -
- Marketing authorisation
- 99495.00.00
- MA holder
- ZENTIVA PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
PRD400618 · Product
- Active substance
- Everolimus
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12.49 g gram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EG02 — -
- Marketing authorisation
- EU/1/09/538/004
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Everolimus Zentiva 5 mg Tabletten
PRD6778978 · Product
- Active substance
- Everolimus
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12.49 g gram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EG02 — -
- Marketing authorisation
- 99494.00.00
- MA holder
- ZENTIVA PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
PRD400622 · Product
- Active substance
- Everolimus
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12.49 g gram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EG02 — -
- Marketing authorisation
- EU/1/09/538/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
SUB02065MIG · Substance
- Active substance
- Everolimus
- Pharmaceutical form
- TABLETS
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12.49 g gram(s)
- Max treatment duration
- 42 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
SUB02065MIG · Substance
- Active substance
- Everolimus
- Pharmaceutical form
- TABLETS
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12.49 g gram(s)
- Max treatment duration
- 42 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
PRD4008058 · Product
- Active substance
- Everolimus
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12.49 g gram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EG02 — -
- Marketing authorisation
- EU/1/09/538/010
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
PRD400620 · Product
- Active substance
- Everolimus
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12.49 g gram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EG02 — -
- Marketing authorisation
- EU/1/09/538/006
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
SUB02065MIG · Substance
- Active substance
- Everolimus
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12.49 g gram(s)
- Max treatment duration
- 42 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
PRD400624 · Product
- Active substance
- Everolimus
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12.49 g gram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EG02 — -
- Marketing authorisation
- EU/1/09/538/003
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Everolimus Zentiva 2,5 mg Tabletten
PRD6778976 · Product
- Active substance
- Everolimus
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12.49 g gram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EG02 — -
- Marketing authorisation
- 99493.00.00
- MA holder
- ZENTIVA PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Comparator 5
MEXABREST 25 mg compresse rivestite con film
PRD416088 · Product
- Active substance
- Exemestane
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 31.22 g gram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG06 — EXEMESTANE
- Marketing authorisation
- 040900045
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
EXEMESTANE ACCORD 25 mg, comprimé pelliculé
PRD416081 · Product
- Active substance
- Exemestane
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 31.22 g gram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG06 — EXEMESTANE
- Marketing authorisation
- 34009 492 953 7 1
- MA holder
- ACCORD HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Exemestan STADA® 25 mg Filmtabletten
PRD394301 · Product
- Active substance
- Exemestane
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 31.22 g gram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG06 — EXEMESTANE
- Marketing authorisation
- 77688.00.00
- MA holder
- STADAPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Faslodex 250 mg solution for injection.
PRD3545736 · Product
- Active substance
- Fulvestrant
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 22.5 g gram(s)
- Max treatment duration
- 42 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
- Yes
- Modification description
- Relabeled for CT use
Tamoxifen 20 PCH, tabletten 20 mg
PRD446358 · Product
- Active substance
- Tamoxifen Citrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 24.98 g gram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BA01 — TAMOXIFEN
- Marketing authorisation
- RVG 10635
- MA holder
- TEVA B.V
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genentech Inc.
- Sponsor organisation
- Genentech Inc.
- Address
- 1 Dna Way
- City
- South San Francisco
- Postcode
- 94080-4918
- Country
- United States
Scientific contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Public contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Everest Clinical Research Corporation ORG-100041734
|
Markham, Canada | Other |
| Foundation Medicine Inc. ORG-100040457
|
Cambridge, United States | Laboratory analysis |
| Almac Clinical Services LLC ORG-100041692
|
Durham, United States | Data management |
| Kayentis ORG-100037894
|
Meylan, France | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Wilmington, United States | Other |
| PPD Global Ltd. ORG-100007531
|
Marousi, Greece | On site monitoring |
Locations
4 EU/EEA countries · 41 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 10 | 10 |
| Greece | Ongoing, recruitment ended | 12 | 12 |
| Italy | Ongoing, recruitment ended | 9 | 8 |
| Spain | Ongoing, recruitment ended | 28 | 11 |
| Rest of world
Singapore, Argentina, Japan, United States, Turkey, Korea, Republic of, South Africa, Taiwan, United Kingdom
|
— | 308 | — |
Investigational sites
Universitaetsklinikum des Saarlandes AöR
Klinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin, Kirrberger Strasse 100, 66421, Homburg
Marienhospital Bottrop gGmbH
N/A, Josef-Albers-Strasse 70, Sued-West-Innenstadt, Bottrop
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
N/A, Langenbeckstrasse 1, Oberstadt, Mainz
Dr. Apel Medizinische Versorgung GmbH
N/A, Bahnhofstrasse 46, Erfurt-Altstadt, Erfurt
Universitaetsklinikum Muenster AöR
Brustzentrum, Albert-Schweitzer-Campus 1, Sentrup, Muenster
St. Johannes Hospital
N/A, Johannesstr. 9-17, 44137, Dortmund
Franziskus Hospital Harderberg
N/A, Alte Rothenfelder Strasse 23, Harderberg, Georgsmarienhuette
Universitaetsklinikum Erlangen AöR
Frauenklinik, Abteilung, Gynäkologische Onkologie, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Universitaetsklinikum Duesseldorf AöR
N/A, Moorenstrasse 5, Bilk, Duesseldorf
National Center For Tumor Diseases (NCT) Heidelberg
Nationales Zentrum für Tumorerkrankungen (NCT), Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Euromedica General Clinic Of Thessaloniki
Oncology Department, Kallas Marias 11, Gravias 2, Thessaloniki
Olympion Therapeftirio General Clinic Of Patras S.A.
Pathological Division of Oncology, Volou & Meilichou, Kato Sychaina, Patra
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Oncology and Clinical trials and research Clinic, Leoforos Mesogeion 264, 155 62, Cholargos
General University Hospital Of Larissa
Oncology clinic, P. O. Box 1425, 411 10, Larissa
Alexandra Hospital
Haematology-Oncology department of Therapeutic Clinic, Vassilissas Sofias Avenue 80, 115 28, Athens
Athens Medical Center S.A.
Oncology Clinic, Pylea, Asklipiou 10, Thessaloniki
University General Hospital Of Heraklion
Internal Medicine – Oncology Clinic, Stavrakia And Voutes, 715 00, Heraklion
Iaso Private General Obstetrics Gynecological & Pediatric Clinic Diagnostic Therapeutic & Research Center S.A.
Obstetrics - Gynecology Clinic, B’ Oncology Clinic, Kifissias Leoforos 37-39, 151 23, Filothei
University General Hospital Attikon
2nd Propaedeutic Internal Medicine Department, Rimini Street 1, 124 62, Athens
General University Hospital Of Patras
Division of Oncology, Rio, 265 04, Patras
Metaxa Cancer Center Hospital Of Piraeus
Medical Oncology, Botassi 51, 185 37, Pireas
St. Luke's Hospital S.A.
Department of Medical Oncology, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
Azienda Ospedaliero Universitaria Di Modena
Medical Oncology, Largo Del Pozzo 71, 41124, Modena
Azienda Ospedaliera Universitaria Integrata Verona
Dipartimento di Oncologia, Piazzale Aristide Stefani 1, 37126, Verona
ASST Grande Ospedale Metropolitano Niguarda
Dipartimento Ematologia, Oncologia e Medicina Molecolare (Oncologia Falck), Piazza Dell'ospedale Maggiore 3, 20162, Milan
I.F.O. Istituti Fisioterapici Ospitalieri
Department of clinical and experimental oncology (UOSD Phase 4 Clinical Unit), Via Elio Chianesi N 53, 00144, Rome
Azienda Ospedaliero Universitaria Delle Marche
Clinica di Oncologia Medica, Via Conca 71, 60126, Ancona
Fondazione IRCCS San Gerardo Dei Tintori
Breast Unit (Phase 1 Research Center), Via Giovanni Battista Pergolesi 33, 20900, Monza
Universita' Degli Studi Di Ferrara
Medical Oncology, Via Aldo Moro 8, 44124, Ferrara
IRCCS Ospedale Policlinico San Martino
Oncologia Medica, Largo Rosanna Benzi 10, 16132, Genoa
Hospital Universitari Dexeus Grupo Quironsalud
Servicio de Oncología, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario 12 De Octubre
Servicio de Oncología, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Ramon Y Cajal
Servicio de Oncología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Clinico Universitario De Valencia
Servicio de Oncología, Avenida Blasco Ibanez 17, 46010, Valencia
Complexo Hospitalario Universitario A Coruna
Servicio de Oncología, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Reina Sofia
Servicio de Oncología, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital General Universitario Morales Meseguer
Servicio de Oncología, Avenida Del Marques De Los Velez S/n, 30008, Murcia
Hospital Clinico San Carlos
Servicio de Oncología, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital General Universitario Gregorio Maranon
Servicio de Oncología, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario Virgen De Las Nieves
Servicio de Oncología, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Clinic De Barcelona
Servicio de Oncología, Calle Villarroel 170, 08036, Barcelona
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 |
|---|---|---|---|---|---|
| Germany | 2023-11-17 | 2023-12-14 | 2024-09-17 | ||
| Greece | 2023-10-12 | 2023-10-18 | 2024-09-17 | ||
| Italy | 2023-12-22 | 2024-02-07 | 2024-09-17 | ||
| Spain | 2023-10-12 | 2023-10-16 | 2024-09-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 114 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-506821-12-00 GR Redacted | 4 |
| Protocol (for publication) | D1_Protocol 2023-506821-12-00 Redacted | 4 |
| Protocol (for publication) | d4_patient-facing-documents_bpi-sf_de-de | 1 |
| Protocol (for publication) | d4_patient-facing-documents_bpi-sf_eng | 2 |
| Protocol (for publication) | d4_patient-facing-documents_bpi-sf_es | 1 |
| Protocol (for publication) | d4_patient-facing-documents_bpi-sf_gr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_bpi-sf_it | 1 |
| Protocol (for publication) | d4_patient-facing-documents_ctcae_de-de | 2 |
| Protocol (for publication) | d4_patient-facing-documents_ctcae_eng | 1 |
| Protocol (for publication) | d4_patient-facing-documents_ctcae_es | 2 |
| Protocol (for publication) | d4_patient-facing-documents_ctcae_gr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_ctcae_it | 2 |
| Protocol (for publication) | d4_patient-facing-documents_ctcae_it_redline | 2 |
| Protocol (for publication) | d4_patient-facing-documents_diary_de-de | 2 |
| Protocol (for publication) | d4_patient-facing-documents_diary_eng | 1 |
| Protocol (for publication) | d4_patient-facing-documents_diary_es | 1 |
| Protocol (for publication) | d4_patient-facing-documents_diary_gr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_diary_it | 1 |
| Protocol (for publication) | d4_patient-facing-documents_eq-5d-5l_de-de | 2 |
| Protocol (for publication) | d4_patient-facing-documents_eq-5d-5l_eng | 1 |
| Protocol (for publication) | d4_patient-facing-documents_eq-5d-5l_es | 1 |
| Protocol (for publication) | d4_patient-facing-documents_eq-5d-5l_gr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_eq-5d-5l_it | 1 |
| Protocol (for publication) | d4_patient-facing-documents_factgp5_de-de | 2 |
| Protocol (for publication) | d4_patient-facing-documents_factgp5_eng | 1 |
| Protocol (for publication) | d4_patient-facing-documents_factgp5_es | 2 |
| Protocol (for publication) | d4_patient-facing-documents_factgp5_gr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_factgp5_it | 1 |
| Protocol (for publication) | d4_patient-facing-documents_lqbr23_de-de | 2 |
| Protocol (for publication) | d4_patient-facing-documents_qlqbr23_eng | 2 |
| Protocol (for publication) | d4_patient-facing-documents_qlqbr23_es | 3 |
| Protocol (for publication) | d4_patient-facing-documents_qlqbr23_gr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_qlqbr23_it | 2 |
| Protocol (for publication) | d4_patient-facing-documents_qlqbr23_it_redline | 2 |
| Protocol (for publication) | d4_patient-facing-documents_qlqbr30_it_redline | 2 |
| Protocol (for publication) | d4_patient-facing-documents_qlqc30_de-de | 2 |
| Protocol (for publication) | d4_patient-facing-documents_qlqc30_eng | 2 |
| Protocol (for publication) | d4_patient-facing-documents_qlqc30_es | 2 |
| Protocol (for publication) | d4_patient-facing-documents_qlqc30_gr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_qlqc30_it | 2 |
| Protocol (for publication) | d4_patient-facing-documents_study schedule-planner_gr | 2 |
| Protocol (for publication) | d4_patient-facing-documents_study-schedule-planner_de-de | 2 |
| Protocol (for publication) | d4_patient-facing-documents_study-schedule-planner_eng | 2 |
| Protocol (for publication) | d4_patient-facing-documents_study-schedule-planner_es | 2 |
| Protocol (for publication) | d4_patient-facing-documents_study-schedule-planner_it | 2 |
| Protocol (for publication) | d4_patient-facing-documents_training byod_gr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_training-byod_de-de | 2 |
| Protocol (for publication) | d4_patient-facing-documents_training-byod_eng | 2 |
| Protocol (for publication) | d4_patient-facing-documents_training-byod_es | 1 |
| Protocol (for publication) | d4_patient-facing-documents_training-byod_it | 1 |
| Protocol (for publication) | d4_patient-facing-documents_training-on-site_de-de | 2 |
| Protocol (for publication) | d4_patient-facing-documents_training-on-site_eng | 3 |
| Protocol (for publication) | d4_patient-facing-documents_training-on-site_es | 1 |
| Protocol (for publication) | d4_patient-facing-documents_training-on-site_gr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_training-on-site_it | 1 |
| Recruitment arrangements (for publication) | K1_ML43171_GP-Letter_IT_Italian_Public | 2 |
| Recruitment arrangements (for publication) | K1_ML43171_Recruitment Arrangements_ES_Public | n/a |
| Recruitment arrangements (for publication) | K1_ML43171_Recruitment Arrangements_GRC_Public | n/a |
| Recruitment arrangements (for publication) | K1_ML43171_Recruitment-and-ICF-Procedure_IT_Public | n/a |
| Recruitment arrangements (for publication) | K1_ML43171_Recruitment-Arrangements_DE_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_ML43171_HCP_Letter_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_ML43171_Licensed Understanding Clinical Trials Adults_GRC_EL_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_ML43171_Newspaper AD_GRC_EL_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_ML43171_Newspaper_Advert_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_ML43171_Poster_ES_Spanish_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_ML43171_Recruitment Poster_GRC_EL_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_ML43171_Tote Bag_GRC_Public | n/a |
| Recruitment arrangements (for publication) | K2_ML43171_Trifold_ES_Spanish_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_ML43171_Trifold_GRC_EL_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_ML43171_Understanding Breast CA and Study_ES_Spanish_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_ML43171_Understanding Cancer for Kids 7-12 - Licensed_GRC_EL_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_ML43171_Understanding Your Condition and Study_GRC_EL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_Biobanking-ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_HCP-Letter_DE_German_Public | 1 |
| Subject information and informed consent form (for publication) | L1_ML43171_IAF ICF_GRC_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_IAF ICF_GRC_Greek_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_IC Flipchart_DE_German_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ML43171_ICF Infant Authorization Form_IT Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_ICF Main_IT Italian_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_ICF Pregnant Partner_IT Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_Main ICF_GRC_English_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_Main ICF_GRC_Greek_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_Main_ICF_ES_Spanish_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_Main-ICF_DE_German_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_Newspaper AD_DE_German_Publicer_Public | 1 |
| Subject information and informed consent form (for publication) | L1_ML43171_Optional RBR ICF_GRC_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_Optional RBR ICF_GRC_Greek_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_PPA ICF_GRC_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_PPA ICF_GRC_Greek_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_Pregnant-Partner-ICF_DE_German_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ML43171_Recruitment Poster_DE_German_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ML43171_Ring cards_DE_German_Public | 1 |
| Subject information and informed consent form (for publication) | L1_ML43171_Study Coordinator Tearpad_DE_German_Public | 1 |
| Subject information and informed consent form (for publication) | L1_ML43171_Study Schedule Planner_DE_German_Public | 1 |
| Subject information and informed consent form (for publication) | L1_ML43171_Study Welcome Guide_DE_German_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ML43171_Thank You Card_DE_German_Public | 1 |
| Subject information and informed consent form (for publication) | L1_ML43171_Tote Bag_DE_German_Public | n/a |
| Subject information and informed consent form (for publication) | L1_ML43171_Trifold_DE_German_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ML43171_Understanding Cancer for Kids 7y-12y_DE_German_Public | 1 |
| Subject information and informed consent form (for publication) | L1_ML43171_Understanding Clinical Trials_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ML43171_Understanding Your Condition_DE_German_Public | 1.1 |
| Subject information and informed consent form (for publication) | L2_ML43171_Pregnant_Partner_ICF_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L3_ML43171_Newborn_data_ICF_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L4_ML43171_RB_Repository_ICF_ES_Spanish_Public | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Afinitor | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC EXEMESTANE ACCORD 25 mg comprime pellicule | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Faslodex 250 mg solution for injection.pdf | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Tamoxifen 20 PCH tabletten 20 mg.pdf | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-everolimus redline | NA |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-fulvestrant redline | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2023-506821-12-00.pdf | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES 2023-506821-12-00.pdf | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GR-GR 2023-506821-12-00.pdf | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT 2023-506821-12-00.pdf | 4 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-24 | Germany | Acceptable 2024-06-05
|
2024-06-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-25 | Germany | Acceptable 2024-06-05
|
2024-07-25 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-26 | Germany | Acceptable 2024-06-05
|
2024-07-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-12 | Germany | Acceptable 2024-12-03
|
2024-12-03 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-28 | Acceptable | 2025-05-12 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-16 | Germany | Acceptable 2025-08-27
|
2025-08-27 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-15 | Germany | Acceptable 2025-08-27
|
2025-12-15 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-12-17 | Germany | Acceptable 2025-08-27
|
2025-12-17 |