Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
458
Countries
6
Sites
48
Metastatic breast cancer
To evaluate the efficacy of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant on the basis of blinded independent central review (BICR)-assessed progression free survival (PFS)
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Sep 2023 → ongoing
- Decision date (initial)
- 2023-06-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche AG
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Pharmacokinetic
To evaluate the efficacy of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant on the basis of blinded independent central review (BICR)-assessed progression free survival (PFS)
Secondary objectives 3
- • To evaluate the efficacy of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant on the basis of overall survival (OS); BICR-assessed objective response rate (ORR), best overall response (BOR), clinical benefit rate; (CBR), and duration of response (DOR); and times to deterioration in pain, physical function, role function, and global health status (GHS)/health-related quality of life (HRQoL)
- To evaluate the safety and tolerability of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant
- To characterize the pharmacokinetics of inavolisib in the inavolisib + fulvestrant arm
Conditions and MedDRA coding
Metastatic breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 23.0 | PT | 10083234 | Hormone receptor positive breast cancer | 100000004864 |
| 20.1 | PT | 10055113 | Breast cancer metastatic | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | WO43919 - Phase III, open label, inavolisib plus fulvestrant versus alpelisib, breast cancer patient This is a phase III, randomized, open label study to evaluate efficacy and safety of inavolisib plus fulvestrant versus alpelisib in patients with HER-2 negative PIK3CA, mutated, locally advanced or metastatic breast cancer
|
Randomised Controlled | None | [{"id":166476,"code":1,"name":"Subject"},{"id":166473,"code":3,"name":"Monitor"},{"id":166475,"code":2,"name":"Investigator"},{"id":166474,"code":5,"name":"Carer"}] | Arm A - Inavolisib plus Fulvestrant: Arm A - Inavolisib plus Fulvestrant Arm B - Alpelisib plus fulvestrant: Arm B - Alpelisib plus fulvestrant |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent
- Documented HR +/ -positive/HER2-negative (HR +/ HER2 -) tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
- Confirmation of biomarker eligibility: detection of specified mutation(s) of phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) via specified test
- Disease progression after or during treatment with a combination of cyclin dependent kinase 4/6i (CDK4/6i) and endocrine therapy , ⩽ 2 prior lines of systemic therapy in mBC setting, CDK4/6i based therapy does not need to be the last one received prior study entry, One line of chemotherapy in mBC setting allowed
- Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Exclusion criteria 6
- Prior treatment in locally advanced or metastatic setting with any phosphatidylinositol 3-kinase (PI3K, ), protein kinase B (AKT,), or mammalian target of rapamycin (mTOR) inhibitor or any agent whose mechanism of action is to inhibit the PI3K/-AKT/-mTOR pathway.
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition OR active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
- History of or active inflammatory bowel disease OR any active bowel inflammation
- History of severe cutaneous reactions like Stevens-Johnson Syndrome, (SJS), Erythema Multiforme, (EM), Toxic Epidermal Necrolysis, (TEN), or Drug Reaction with Eosinphilia and Systemic Symptoms (DRESS)
- Active ongoing osteonecrosis of the jaw
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- blinded independent central review (BICR-)-assessed progression-free survival (PFS)
Secondary endpoints 12
- Overall survival OS
- BICR-assessed Overall Response Rate
- BICR-assessed Best Overall Response
- BICR-assessed Clinical benefit rate
- BICR-assessed Duration of Response
- . Time to confirmed a deterioration (TTCD) in pain
- TTCD in physical functioning
- TTCD in role functioning
- TTCD in global health status/QOL
- Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) grading scale; treatment discontinuations due to adverse events
- Change from baseline in targeted clinical laboratory test results
- Plasma concentration of inavolisib at specified timepoints
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD9793132 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 21.42 g gram(s)
- Max treatment duration
- 85 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9793811 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 21.42 g gram(s)
- Max treatment duration
- 85 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9793130 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 21.42 g gram(s)
- Max treatment duration
- 85 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 7
Piqray 200 mg film-coated tablets
PRD8234907 · Product
- Active substance
- Alpelisib
- Substance synonyms
- (2S)-N1-(4-METHYL-5-(1-(1,1,1-TRIFLUORO-2-METHYLPROPAN-2-YL)PYRIDIN-4-YL)-1,3-THIAZOL-2-YL)PYRROLIDINE-1,2-DICARBOXAMIDE, BYL719
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 714 g gram(s)
- Max treatment duration
- 85 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EM03 — -
- Marketing authorisation
- EU/1/20/1455/008
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Piqray 50 mg and 200 mg film-coated tablets
PRD8235740 · Product
- Active substance
- Alpelisib
- Substance synonyms
- (2S)-N1-(4-METHYL-5-(1-(1,1,1-TRIFLUORO-2-METHYLPROPAN-2-YL)PYRIDIN-4-YL)-1,3-THIAZOL-2-YL)PYRROLIDINE-1,2-DICARBOXAMIDE, BYL719
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 714 g gram(s)
- Max treatment duration
- 85 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EM03 — -
- Marketing authorisation
- EU/1/20/1455/005
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB180707 · Substance
- Active substance
- Alpelisib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 714 g gram(s)
- Max treatment duration
- 85 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB180707 · Substance
- Active substance
- Alpelisib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 714 g gram(s)
- Max treatment duration
- 85 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Piqray 150 mg film-coated tablets
PRD8234895 · Product
- Active substance
- Alpelisib
- Substance synonyms
- (2S)-N1-(4-METHYL-5-(1-(1,1,1-TRIFLUORO-2-METHYLPROPAN-2-YL)PYRIDIN-4-YL)-1,3-THIAZOL-2-YL)PYRROLIDINE-1,2-DICARBOXAMIDE, BYL719
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 714 g gram(s)
- Max treatment duration
- 85 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EM03 — -
- Marketing authorisation
- EU/1/20/1455/002
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB180707 · Substance
- Active substance
- Alpelisib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 714 g gram(s)
- Max treatment duration
- 85 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13933MIG · Substance
- Active substance
- Fulvestrant
- Pharmaceutical form
- SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE.
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 43 g gram(s)
- Max treatment duration
- 85 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
SUB08831MIG · Substance
- Active substance
- Metformin
- Pharmaceutical form
- FILM COATED TABLETS
- Route of administration
- ORAL
- Max daily dose
- 3 g gram(s)
- Max total dose
- 3 g gram(s)
- Max treatment duration
- 85 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
L02AE · Product
- Pharmaceutical form
- PHF00243MIG
- Route of administration
- INJECTION
- Max daily dose
- 0.13 mg milligram(s)
- Max total dose
- 306 mg milligram(s)
- Max treatment duration
- 85 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02AE — GONADOTROPIN RELEASING HORMONE ANALOGUES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone Sodium Phosphate
SUB01615MIG · Substance
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- MOUTHWASH
- Route of administration
- TOPICAL
- Max daily dose
- 4 g gram(s)
- Max total dose
- 896 g gram(s)
- Max treatment duration
- 85 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
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel Town
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Publicis Healthcare Communications Group Limited ORG-100044665
|
London, United Kingdom | Other |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Other |
| Cellcarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
| Foundation Medicine Inc. ORG-100040457
|
Cambridge, United States | Laboratory analysis |
| Median Technologies ORG-100041462
|
Valbonne, France | Other |
| Labcorp Central Laboratories Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
Locations
6 EU/EEA countries · 48 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 12 | 6 |
| France | Ongoing, recruitment ended | 24 | 8 |
| Germany | Ongoing, recruitment ended | 30 | 11 |
| Italy | Ongoing, recruitment ended | 42 | 4 |
| Poland | Ongoing, recruitment ended | 20 | 8 |
| Spain | Ongoing, recruitment ended | 22 | 11 |
| Rest of world
Canada, United Kingdom, Turkey, United States, Brazil, South Africa, Australia, Mexico, China, Thailand, Argentina, Korea, Republic of, Taiwan
|
— | 308 | — |
Investigational sites
Antwerp University Hospital
Oncology (Breast clinic & Multidisciplinary oncology centre), Drie Eikenstraat 655, 2650, Edegem
UZ Leuven
Gynaecologic oncology, Herestraat 49, 3000, Leuven
CHU UCL Namur
Medical oncology (Trial office), Place Louise Godin 15, 5000, Namur
Universitair Ziekenhuis Gent
Medical oncology, Corneel Heymanslaan 10, 9000, Gent
Grand Hopital De Charleroi
Oncology & Hematology, Grand'rue 3, 6000, Charleroi
Cliniques Universitaires Saint-Luc
Medical oncology (Institut Roi Albert II), Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Polyclinique Bordeaux Nord Aquitaine
Radiothérapie, 15 Rue Claude Boucher, Cs 31396, Bordeaux Cedex
Centre De Lutte Contre Le Cancer Eugene Marquis
Oncologie Médicale, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Institut Regional Du Cancer De Montpellier
Oncologie Médicale, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Centre Hospitalier De La Cote Basque
Oncologie Médicale, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Centre Leon Berard
Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Institut Sainte Catherine
Oncologie Médicale, 250 Chemin De Baigne Pieds, 84000, Avignon
Centr Georges Francois Leclerc
Oncologie Médicale, 1 Rue Professeur Marion, 21000, Dijon
Institut Universitaire Du Cancer Toulouse-Oncopole
Oncologie Médicale, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Medizinische Hochschule Hannover Service GmbH
Frauenklinik Gynäkologische Onkologie, Chemoambulanz, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Franziskus Hospital Harderberg
MVZ II der Niels-Stensen-Kliniken Zentrum für Internistische Onkologie und Hämatologie, Alte Rothenfelder Strasse 23, Harderberg, Georgsmarienhuette
Mammazentrum Hamburg MVZ GbR
N.A., Moorkamp 2-6, Eimsbuettel, Hamburg
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
N.A., Wirthstrasse 11c, Landwasser, Freiburg Im Breisgau
Klinikum Der Universitat Munchen AöR
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Standort Innenstadt, Ziemssenstrasse 1, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsmedizin Goettingen
Klinik für Gynäkologie und Geburtshilfe, Robert-Koch-Strasse 40, Weende, Goettingen
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
N.A., Ludwig-Weber-Strasse 15, Stadtmitte, Moenchengladbach
St. Vincenz Krankenhaus GmbH
Frauen- und Kinderklinik St. Louise, Am Busdorf 2, Kernstadt, Paderborn
Universitaetsklinikum Aachen AöR
Klinik für Gynäkologie und Geburtsmedizin, Pauwelsstrasse 30, 52074, Aachen
Nationales Centrum Fuer Tumorerkrankungen Heidelberg
Sektion Gynäkologische Onkologie, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Universitaetsklinikum Essen AöR
Klinik für Frauenheilkunde und Geburtshilfe, Brustzentrum Essen I am Westdeutschen Tumorzentrum, Hufelandstrasse 55, Holsterhausen, Essen
Ospedale San Raffaele S.r.l.
Oncologia Medica, Via Olgettina 60, 20132, Milan
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Azienda Provinciale Per I Servizi Sanitari
U.O. Oncologia, Largo Medaglie D'oro 9, 38122, Trento
Azienda Ospedaliera Sant Anna E San Sebastiano Di Caserta
UOC Oncologia Medica, Via Ferdinando Palasciano Snc, 81100, Caserta
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
I Przychodnia Lekarska Komed Roman Karaszewski II Osrodek Badan Klinicznych III Restauracja Rogatka Roman Karaszewski
NA, Ul. Wojska Polskiego 6, 62-500, Konin
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddział Dzienny Chemioterapii, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Szpitale Pomorskie Sp. z o.o.
Oddział Onkologii Klinicznej - Profil Dzienny, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Mruk-Med I Sp. z o.o.
NA, Ul. Gen. Mariana Langiewicza 61, 35-021, Rzeszow
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Onkologii, Ul. Mikolaja Kopernika 50, 31-501, Cracow
Centrum Onkologii Im Prof Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Oddział w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Catalan Institute Of Oncology
Oncología, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital General Universitario Gregorio Maranon
Oncología, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Ramon Y Cajal
Oncología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
University Hospital Of Canary Islands
Oncología, Carretera De La Cuesta Taco S/n, Cuesta La, San Cristobal De La Laguna
Hospital San Pedro De Alcantara
Oncología, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Complexo Hospitalario Universitario De Santiago
Oncología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Regional De Malaga
Oncología, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario 12 De Octubre
Oncología, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitario Virgen De La Macarena
Oncología, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitari Vall D Hebron
Oncología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
University Clinical Hospital Virgen De La Arrixaca
Oncología, Carretera De Cartagena S/n, El Palmar, Murcia
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 |
|---|---|---|---|---|---|
| Belgium | 2023-10-23 | 2023-11-28 | 2024-10-23 | ||
| France | 2024-05-22 | 2024-05-23 | 2024-10-23 | ||
| Germany | 2024-06-04 | 2024-06-07 | 2024-10-23 | ||
| Italy | 2024-04-22 | 2024-04-26 | 2024-10-23 | ||
| Poland | 2023-12-21 | 2024-01-30 | 2024-10-23 | ||
| Spain | 2023-09-12 | 2023-09-14 | 2024-10-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 149 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Race ethnicity_MEMO_2023_2022-502322-41-00 | 1 |
| Protocol (for publication) | D1_Protocol 2022-502322-41-00 Redacted | 4 |
| Protocol (for publication) | D1_Protocol Clarification Letter Biopsy 2022-502322-41-00 Redacted | n/a |
| Protocol (for publication) | D1_Protocol Clarification Letter IVD 2022-502322-41-00 Redacted | n/a |
| Protocol (for publication) | D1_Protocol Protocol Clarification Letter 2022-502322-41-00 Redacted | n/a |
| Protocol (for publication) | d1_protocol-clarification-letter-2022-502322-41-00-redacted | n/a |
| Protocol (for publication) | D4_ Patient facing documents_BPI-SF_BE-NL | NA |
| Protocol (for publication) | D4_ Patient facing documents_BPI-SF_DE | NA |
| Protocol (for publication) | D4_ Patient facing documents_BPI-SF_ES | NA |
| Protocol (for publication) | D4_ Patient facing documents_BPI-SF_FR | NA |
| Protocol (for publication) | D4_ Patient facing documents_BPI-SF_IT | NA |
| Protocol (for publication) | D4_ Patient facing documents_BPI-SF_PL | NA |
| Protocol (for publication) | D4_ Patient facing documents_BR23_BE-NL | 1 |
| Protocol (for publication) | D4_ Patient facing documents_BR23_DE | 1 |
| Protocol (for publication) | D4_ Patient facing documents_BR23_ES | 1 |
| Protocol (for publication) | D4_ Patient facing documents_BR23_FR | 1 |
| Protocol (for publication) | D4_ Patient facing documents_BR23_IT | 1 |
| Protocol (for publication) | D4_ Patient facing documents_BR23_PL | 1 |
| Protocol (for publication) | D4_ Patient facing documents_ctcae_BE-NL | 1 |
| Protocol (for publication) | D4_ Patient facing documents_ctcae_DE | 1 |
| Protocol (for publication) | D4_ Patient facing documents_ctcae_ES | 1 |
| Protocol (for publication) | D4_ Patient facing documents_ctcae_FR | 1 |
| Protocol (for publication) | D4_ Patient facing documents_ctcae_IT | 1 |
| Protocol (for publication) | D4_ Patient facing documents_ctcae_PL | 1 |
| Protocol (for publication) | D4_ Patient facing documents_EQ-5D-5L_BE-FR | 1 |
| Protocol (for publication) | D4_ Patient facing documents_EQ-5D-5L_BE-NL | 1 |
| Protocol (for publication) | D4_ Patient facing documents_EQ-5D-5L_DE | 1 |
| Protocol (for publication) | D4_ Patient facing documents_EQ-5D-5L_ES | 1 |
| Protocol (for publication) | D4_ Patient facing documents_EQ-5D-5L_FR | 1 |
| Protocol (for publication) | D4_ Patient facing documents_EQ-5D-5L_IT | 1 |
| Protocol (for publication) | D4_ Patient facing documents_EQ-5D-5L_PL | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose Diary_BE-ENG | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose Diary_BE-FR | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose Diary_BE-NL | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose Diary_DE | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose Diary_ENG | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose Diary_ES | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose Diary_IT | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose Diary_PL | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose Diary_Redline_BE-ENG | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose Diary_Redline_BE-NL | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose Diary_Redline_DE | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose Diary_Redline_ES | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose Diary_Redline_FR | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose Diary_Redline_IT | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose DiaryRedline_BE-FR | 2 |
| Protocol (for publication) | D4_ Patient facing documents_Glucose DiaryRedline_PL | 2 |
| Protocol (for publication) | D4_ Patient facing documents_GP5 SPA_BE-NL | 4 |
| Protocol (for publication) | D4_ Patient facing documents_GP5 SPA_DE | 4 |
| Protocol (for publication) | D4_ Patient facing documents_GP5 SPA_ES | 4 |
| Protocol (for publication) | D4_ Patient facing documents_GP5 SPA_FR | 4 |
| Protocol (for publication) | D4_ Patient facing documents_GP5 SPA_IT | 4 |
| Protocol (for publication) | D4_ Patient facing documents_GP5 SPA_PL | 4 |
| Protocol (for publication) | D4_ Patient facing documents_QLQ-C30_BE-NL | 3 |
| Protocol (for publication) | D4_ Patient facing documents_QLQ-C30_DE | 3 |
| Protocol (for publication) | D4_ Patient facing documents_QLQ-C30_ES | 3 |
| Protocol (for publication) | D4_ Patient facing documents_QLQ-C30_FR | 3 |
| Protocol (for publication) | D4_ Patient facing documents_QLQ-C30_IT | 3 |
| Protocol (for publication) | D4_ Patient facing documents_QLQ-C30_PL | 3 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm A_BE-ENG | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm A_BE-FR | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm A_BE-NL | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm A_DE | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm A_ENG | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm A_ES | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm A_FR-FR | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm A_IT | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm A_PL | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm B_BE-ENG | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm B_BE-FR | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm B_BE-NL | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm B_DE | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm B_ENG | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm B_ES | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm B_FR-FR | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm B_IT | 1 |
| Protocol (for publication) | D4_ Patient facing documents_Study Medication Diary_Arm B_PL | 1 |
| Protocol (for publication) | D4_Patient facing documents_Glucose Diary_FR-FR | 2 |
| Recruitment arrangements (for publication) | 2022-502322-41-00_Carte Patient_WO43919 | 2 |
| Recruitment arrangements (for publication) | 2022-502322-41-00_Document additionnel_WO43919_redacted | 1 |
| Recruitment arrangements (for publication) | 2022-502322-41-00_Recruitment and Informed Consent procedure_WO43919 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_WO43919_DEU_Recruitment_and_Informed_Consent_Procedure_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements no material_ Redacted | 1 |
| Subject information and informed consent form (for publication) | 2022-502322-41-00_NIFC Biopsies optionnelles_WO43919_redacted | 2 |
| Subject information and informed consent form (for publication) | 2022-502322-41-00_NIFC Enfant ne_WO43919_redacted | 3 |
| Subject information and informed consent form (for publication) | 2022-502322-41-00_NIFC Partenaire Enceinte_WO43919_redacted | 3 |
| Subject information and informed consent form (for publication) | 2022-502322-41-00_NIFC RBR_WO43919_clean | 2 |
| Subject information and informed consent form (for publication) | 2022-502322-41-00_NIFC Test de preselection_WO43919_redacted | 1 |
| Subject information and informed consent form (for publication) | 2022-502322-41-00_Recruitment and Informed Consent procedure_WO43919 | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF IAF | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_REDACTED | 5 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF optional biopsies_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF optional web-based questionnaires | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF PPA | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Prescreening RBR_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF prescreening_REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF RBR | 2 |
| Subject information and informed consent form (for publication) | L1_General Practictioner Letter_File Note | NA |
| Subject information and informed consent form (for publication) | L1_Greenphire_ClinCard direct deposit FAQ_EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_Greenphire_ClinCard direct deposit FAQ_FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_Greenphire_ClinCard direct deposit FAQ_NL | 2 |
| Subject information and informed consent form (for publication) | L1_Greenphire_Reimbursement info sheet_EN | 8.0 |
| Subject information and informed consent form (for publication) | L1_Greenphire_Reimbursement info sheet_FR | 8.0 |
| Subject information and informed consent form (for publication) | L1_Greenphire_Reimbursement info sheet_NL | 8.0 |
| Subject information and informed consent form (for publication) | L1_Privacy consent form other subject | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and _ICF_Prescreening_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for the use and sharing of infant health information | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EN_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_NL_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnancy partner | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening_EN_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening_FR_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening_NL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF prescreening_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_WO43919_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biopsy_WO43919_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreen_WO43919_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_WO43919_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_WO43919_DEU_ICF_PROs | 1 |
| Subject information and informed consent form (for publication) | L2_Informed consent form procedure | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | e2_SmPC Faslodex | NA |
| Summary of Product Characteristics (SmPC) (for publication) | e2_SmPC Piqray | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-DE_2022-502322-41-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-ENG_2022-502322-41-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-FR_2022-502322-41-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-NL_2022-502322-41-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE 2022-502322-41-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2022-502322-41-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES 2022-502322-41-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR-FR_2022-502322-41-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT 2022-502322-41-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL 2022-502322-41-00 | 1 |
Application history
18 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-03 | Belgium | Acceptable with conditions 2023-06-25
|
2023-06-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-07-12 | Belgium | Acceptable with conditions 2023-06-25
|
2023-07-12 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-07-14 | Acceptable with conditions 2023-06-25
|
2023-07-14 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2023-08-07 | Acceptable with conditions 2023-06-25
|
2023-08-07 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-11 | Belgium | Acceptable 2023-10-25
|
2023-10-25 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2023-11-06 | Belgium | 2023-11-06 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-12-14 | Acceptable | 2024-03-15 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-15 | Acceptable | 2024-01-23 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-12-15 | Acceptable | 2024-01-22 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-03-18 | Acceptable | 2024-03-18 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-04-03 | Belgium | Acceptable 2024-06-28
|
2024-06-28 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2024-07-17 | Belgium | Acceptable 2024-06-28
|
2024-07-17 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2024-09-16 | Acceptable 2024-06-28
|
2024-09-16 | |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-10 | 2024-09-26 | Acceptable 2024-06-28
|
2024-09-26 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-11-08 | Belgium | Acceptable 2025-02-04
|
2025-02-04 |
| 16 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-03-21 | Belgium | Acceptable 2025-06-02
|
2025-06-04 |
| 17 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-10-08 | Belgium | Acceptable 2025-11-27
|
2025-11-27 |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-11 | 2026-02-10 | Belgium | Acceptable 2025-11-27
|
2026-02-10 |