Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
922
Countries
8
Sites
73
Locally-Advanced unresectable or Metastatic breast cancer (MBC)
To evaluate the efficacy of Phesgo plus giredestrant compared with Phesgo based on 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
- 24 Jun 2022 → ongoing
- Decision date (initial)
- 2022-06-16
- 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: Efficacy, Safety
To evaluate the efficacy of Phesgo plus giredestrant compared with Phesgo based on progression-free survival (PFS)
Secondary objectives 2
- To evaluate the efficacy of Phesgo plus giredestrant compared with Phesgo based on overall survival (OS), objective response rate (ORR), duration of response (DOR), clinical benefit rate (CBR), mean and mean change from baseline score of functional and global health status/ quality of life (GHS/QoL) scales of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
- To evaluate the safety of Phesgo plus giredestrant compared with Phesgo
Conditions and MedDRA coding
Locally-Advanced unresectable or Metastatic breast cancer (MBC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10065430 | HER2 positive breast cancer | 100000004864 |
| 23.0 | LLT | 10070575 | Estrogen receptor positive breast cancer | 10029104 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Induction therapy During the induction therapy phase, all participants will receive Phesgo in combination with a taxane (i.e., docetaxel or paclitaxel), as per the standard of care.
|
Not Applicable | None | ||
| 2 | Maintenance Phase Following the induction therapy phase, participants who meet specific criteria will be eligible for the maintenance phase.
|
Randomised Controlled | None | A: Control arm: Participants will receive Phesgo. B: Experimental arm: Participants will receive giredestrant in combination with Phesgo. |
|
| 3 | Long Term Follow-up Information on survival and new anti-cancer therapy will be collected every 3 months until death.
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Participants (females, regardless of menopausal status, and males) who are aged >=18 years at the time of signing Informed Consent Form
- Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection
- At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Disease-free interval from completion of adjuvant or neoadjuvant systemic nonhormonal treatment to recurrence of >=6 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Left ventricular ejection fraction (LVEF) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
Exclusion criteria 6
- Previous systemic non-hormonal anti-cancer therapy in the metastatic breast cancer (MBC) or advanced breast cancer (ABC) setting
- Previous treatment with approved or investigative anti- human epidermal growth factor receptor 2 (HER2) agents
- Non-resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade 1 or better
- Dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapy
- History of persistent Grade >=2 (NCI-CTC, Version 5.0) hematological toxicity resulting from previous adjuvant or neo-adjuvant therapy
- For pre- and perimenopausal women, and men: 1) Known hypersensitivity to luteinizing hormone-releasing hormone agonist (LHRHa) 2) Not willing to undergo and maintain treatment with approved LHRHa therapy for the duration of endocrine therapy (ET) that requires gonadal function suppression
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. PFS, 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 RECIST v1.1
Secondary endpoints 7
- 1. OS, defined as the time from randomization to death from any cause
- 2. ORR (following randomization), defined as the proportion of participants with a CR or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1
- 3. DOR (following randomization), defined as the time from the first occurrence of a documented objective response (complete response (CR) or partial response (PR) to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
- 4. CBR (following randomization), defined as the proportion of participants with SD or non-CR/non-PD for ≥ 24 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1
- 5. Mean and mean changes from baseline score in function (role, physical) and health-related quality of life (HRQoL) by cycle and between treatment arms as assessed through the use of the Functional and GHS/QoL scales of the EORTC QLQ-C30
- 6. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0
- 7. Change from baseline in targeted clinical laboratory test results
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
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 USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 11340 mg milligram(s)
- Max treatment duration
- 54 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Phesgo 1200 mg/600 mg solution for injection
PRD8600161 · Product
- Active substance
- Trastuzumab
- Substance synonyms
- ABP-980, SYD-977
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XY02 — -
- Marketing authorisation
- EU/1/20/1497/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Phesgo 600 mg/600 mg solution for injection
PRD8601830 · Product
- Active substance
- Trastuzumab
- Substance synonyms
- ABP-980, SYD-977
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 26400 mg milligram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XY02 — -
- Marketing authorisation
- EU/1/20/1497/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use
Auxiliary 7
SCP202373 · ATC
- Active substance
- Tamoxifen
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 7560 mg milligram(s)
- Max treatment duration
- 54 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BA01 — TAMOXIFEN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP247399 · ATC
- Active substance
- Paclitaxel
- Substance synonyms
- ONCOGEL, ABI-007, MBT 0206
- Route of administration
- INFUSION
- Max daily dose
- 80 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1920 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP725130 · ATC
- Active substance
- Anhydrous Docetaxel
- Route of administration
- INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 775 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP139728 · ATC
- Active substance
- Exemestane
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 9450 mg milligram(s)
- Max treatment duration
- 54 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BG06 — EXEMESTANE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP236273 · ATC
- Active substance
- Letrozole
- Route of administration
- ORAL
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 945 mg milligram(s)
- Max treatment duration
- 54 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP140009 · ATC
- Active substance
- Anastrozole
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 378 mg milligram(s)
- Max treatment duration
- 54 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BG03 — ANASTROZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
L02AE · Product
- Pharmaceutical form
- PHF00243MIG
- Route of administration
- ORAL
- Max daily dose
- 3.6 mg milligram(s)
- Max total dose
- 48.6 mg milligram(s)
- Max treatment duration
- 54 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02AE — GONADOTROPIN RELEASING HORMONE ANALOGUES
- 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 14
| Organisation | City, country | Duties |
|---|---|---|
| Cellcarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
| Median Technologies ORG-100041462
|
Valbonne, France | Other |
| Almac ORG-100013160
|
Souderton, United States | Interactive response technologies (IRT) |
| Frontage Laboratories Inc. ORG-100011515
|
Exton, United States | Laboratory analysis |
| Teckro Limited ORG-100041454
|
Dublin, Ireland | Code 5 |
| Q2q Communications Limited ORG-100041455
|
Richmond, United Kingdom | Code 2 |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100012849
|
Meyrin, Switzerland | Other, Laboratory analysis |
| Iqvia Inc. ORG-100010622
|
Durham, United States | On site monitoring |
| Pharmaceutical Product Development LLC ORG-100011560
|
Richmond, United States | Laboratory analysis |
| Labcorp Central Laboratories Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| QPS LLC ORG-100012847
|
Newark, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Code 5 |
| Labcorp Drug Development Inc. ORG-100041590
|
Princeton, United States | Code 13 |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
Locations
8 EU/EEA countries · 73 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 18 | 6 |
| France | Ongoing, recruitment ended | 21 | 10 |
| Germany | Ongoing, recruitment ended | 50 | 13 |
| Hungary | Ongoing, recruitment ended | 18 | 6 |
| Italy | Ongoing, recruitment ended | 40 | 12 |
| Poland | Ongoing, recruitment ended | 30 | 10 |
| Portugal | Ongoing, recruitment ended | 16 | 5 |
| Spain | Ongoing, recruitment ended | 25 | 11 |
| Rest of world
Kenya, Saudi Arabia, South Africa, Brazil, China, Argentina, Mexico, Jordan, India, Lebanon, Turkey, Oman, Egypt, Uganda, United Kingdom, Taiwan, United Arab Emirates, United States, Thailand, Colombia, Korea, Republic of, Qatar
|
— | 704 | — |
Investigational sites
Grand Hopital De Charleroi
Oncology, Grand'rue 3, 6000, Charleroi
Jessa Ziekenhuis
Oncology, Stadsomvaart 11, 3500, Hasselt
Universitair Ziekenhuis Gent
Medical Oncology, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
CHU Ucl Namur
Oncology, Place Louise Godin 15, 5000, Namur
UZ Leuven
Gynaecologic Oncology, Herestraat 49, 3000, Leuven
Centre Catalan D'oncologie
Service Oncologie, 80 Rue Pascal Marie Agasse, 66000, Perpignan
Institut Sainte Catherine
Oncologie Médicale, 250 Chemin De Baigne Pieds, 84000, Avignon
CHUR Of Besançon
Service Oncologie, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Polyclinique Bordeaux Nord Aquitaine
Service Oncologie, 15 Rue Claude Boucher, Cs 31396, Bordeaux Cedex
Hopital Prive Jean Mermoz
Oncologie Médicale, 55 Avenue Jean Mermoz, 69008, Lyon
Centre Hospitalier Universitaire De Poitiers
Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Departmental Hospital Vendee
Service Oncologie, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Universitaire De Grenoble
Service Oncologie, Boulevard De La Chantourne, La Tronche, Grenoble Cedex 9
Institut Curie Hospital
Service Oncologie médicale, 26 Rue D Ulm, 75005, Paris
Centre Hospitalier De La Cote Basque
Service Oncologie, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Medical Center - University of Freiburg
Klinik für Frauenheilkunde, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Sozialstiftung Bamberg Medizinisches Versorgungszentrum Am Bruderwald gGmbH
Klinikum am Bruderwald, Gynäkologie, Buger Strasse 80, Berg, Bamberg
Evang. Kliniken Essen-Mitte gGmbH
Ev. Huyssens-Stiftung/Knappschafts GmbH, Klinik für Senologie / Brustzentrum, Henricistrasse 92, Huttrop, Essen
Gesundheitszentrum Wetterau gGmbH
Gynäkologie, Chaumontplatz 1, 61231, Bad Nauheim
Universitaetsklinikum Tuebingen AöR
Universitäts-Frauenklinik / Department für Frauengesundheit, Calwerstrasse 7, Innenstadt, Tuebingen
Nationales Centrum Fuer Tumorerkrankungen Heidelberg
Sektion Gynäkologische Onkologie, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Saarland University Hospital
Klinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin, Gebaude 9, Kirrberger Strasse, Homburg
MVZ fuer Haematologie und Onkologie Ravensburg GmbH
Studienzentrum, Elisabethenstrasse 19, 88212, Ravensburg
Universitaetsklinikum Regensburg AöR
Klinik f. Frauenheilkunde & Geburtshilfe d. Universität Regensburg am Caritas KH St. Josef, Landshuter Strasse 65, Kasernenviertel, Regensburg
Frauenärzte Am Bahnhofsplatz
not applicable, Bahnhofsplatz 5, Mitte, Hildesheim
Onkozentrum
Onkozentrum Dresden, Leipziger Strasse 118, Pieschen-Sued, Dresden
Gemeinschaftspraxis Für Hämatologie And Onkologie
not applicable, Roentgenstrasse 6 - 8, 63225, Langen (Hessen)
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Gynäkolgie, Feldstrasse 16, Innenstadt, Trier
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Onkologia osztaly, Dozsa Gyorgy Ut 77, 2800, Tatabanya
Bekes Varmegyei Koezponti Korhaz
Onkologia osztaly, Semmelweis Utca 1, 5700, Gyula
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Onkologia osztaly, Tallian Gyula Utca 20-32, 7400, Kaposvar
Semmelweis Egyetem
Belgyogyaszati es Onkologiai Klinika, Baross Utca 23, 1082, Budapest
Budapesti Szent Margit Korhaz
Onkologia osztaly, Becsi ut 132, 1032, Budapest
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelőintézet
Onkologiai Kozpont, Toszegi ut 21., 5000, Szolnok
Humanitas Istituto Clinico Catanese S.p.A.
Oncologia, Contrada Cubba Sp54 11, 95045, Misterbianco
Oncological Institute Veneto
Oncologia Medica 2, Via Gattamelata 64, 35128, Padova
European Institute Of Oncology S.r.l.
Senologia Medica, Via Giuseppe Ripamonti 435, 20141, Milan
Istituto Tumori Napoli Fondazione G. Pascale
Breast Oncology Division, Via Mariano Semmola 53, 80131, Naples
Azienda Unita Sanitaria Locale Della Romagna
Dipartimento Oncoematologico UOC Oncologia, Via Alcide De Gasperi 8, 48121, Ravenna
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
UOC Oncologia Medica, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Unita Sanitaria Locale Della Romagna
UO Oncologia, Viale Luigi Settembrini 2, 47923, Rimini
Azienda Unita Sanitaria Locale Di Reggio Emilia
Oncology Unit, Via Giovanni Amendola 2, 42122, Reggio Emilia
Azienda Unita Sanitaria Locale Toscana Nord Ovest
Oncologia, Via Antonio Cocchi 7/9, 56121, Pisa
Humanitas Research Hospital
Oncologia Medica 1, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Universitaria Federico II Di Napoli
Clinica di Oncologia Medica, Via Sergio Pansini 5, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncologia, Largo Francesco Vito 1, 00168, Rome
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Oddzial Onkologii Klinicznej, Chemioterapii i Badan Klinicznych, Ul. Hubalczykow 1, 76-200, Slupsk
Mrukmed.Lekarz Beata Madej-Mruk I Partner sp.p.
not applicable, Ul. Partyzantow 30a, 35-234, Rzeszow
Nacional Institute Of Oncology Maria Sklodowska Curie
Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Szpital Wojewódzki Im. Mikołaja Kopernika
Oddzial Dzienny Chemioterapii, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
I Przychodnia Lekarska Komed Roman Karaszewski II Ośrodek Badań Klinicznych III Restauracja Rogatka Roman Karaszewski
not applicable, Ul. Wojska Polskiego 6, 62-500, Konin
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Samodzielny Publiczny Zakład Opieki Zdrowotnej Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego
Klinika Onkologii z Odcinkiem Dziennym, Ul. Katowicka 66a, 45-061, Opole
Ars Medical Sp. z o.o.
ODDZIAŁ ONKOLOGII I CHEMIOTERAPII, Al. Wojska Polskiego 43, 64-920, Pila
Szpitale Pomorskie Sp. z o.o.
Oddzial Onkologii Klinicznej, Oddzial Dzienny, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Szpital Kliniczny Im. Heliodora Święcickiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego
Instytut Onkologii Klinika Onkologii, Ul. Stanislawa Przybyszewskiego 49, 60-355, Poznan
Hospital De Loures EPE
Serviço de Oncologia, Avenida Carlos Teixeira 3, 2674-514, Loures
Hospital De Sao Francisco Xavier
Serviço de Oncologia Médica, Estrada Forte Do Alto Duque, 1449-005, Lisbon
Hospital Da Luz S.A.
Oncologia, Avenida Lusiada 100, 1500-650, Lisbon
Instituto Português De Oncologia Do Porto Francisco Gentil EPE
Serviço de Oncologia Médica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
IPO Coimbra Francisco Gentil EPE
Serviço de Oncologia Médica, Avenida Doutor Bissaya Barreto 98, 3000-075, Coimbra
Hospital Arnau De Vilanova De Valencia
Oncology, Calle De San Clemente 12, 46015, Valencia
Hospital Universitario La Paz - Sermas
Oncology, Paseo Castellana 261, 28046, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Universitario Clinico San Cecilio
Oncology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Universitario Juan Ramon Jimenez
Oncology, Ronda Exterior Norte S/n, 21005, Huelva
Hospital Unviersitario Miguel Servet
Oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
University Hospital Of Canary Islands
Oncology, Carretera Cuesta Taco S/N, 38320, San Cristobal De La Laguna
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos S N, 29010, Malaga
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
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 | 2022-10-21 | 2022-12-08 | 2025-04-28 | ||
| France | 2022-10-12 | 2022-11-08 | 2025-04-28 | ||
| Germany | 2022-06-24 | 2022-08-17 | 2025-04-28 | ||
| Hungary | 2022-10-05 | 2023-03-22 | 2025-04-28 | ||
| Italy | 2022-06-27 | 2022-08-04 | 2025-04-28 | ||
| Poland | 2022-10-21 | 2022-12-08 | 2025-04-28 | ||
| Portugal | 2022-08-23 | 2023-01-02 | 2025-04-28 | ||
| Spain | 2022-06-30 | 2022-07-28 | 2025-04-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 243 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_protocol-2022-500014-26-00-redacted | 5 |
| Protocol (for publication) | d1_protocol-clarification-letter1-2022-500014-26-00-redacted | 1 |
| Protocol (for publication) | d1_protocol-clarification-letter2-2022-500014-26-00-redacted | 2 |
| Protocol (for publication) | d1_protocol-clarification-letter3-2022-500014-26-00-redacted | 3 |
| Protocol (for publication) | d1_protocol-clarification-letter4-2022-500014-26-00-redacted | 4 |
| Protocol (for publication) | Protocol Clarification Letter_WO43571_Redacted | N/A |
| Recruitment arrangements (for publication) | ICF procedure- Italy-redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure_Public | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements Redacted | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_WO43571 | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment_Arrangements_REDACTED | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment arrangements_Document additionnel | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material _Poster_V1 | 1 |
| Recruitment arrangements (for publication) | K2_Referal letter | 1 |
| Recruitment arrangements (for publication) | K2_WO43571_ Referral letter | 1 |
| Recruitment arrangements (for publication) | K2_WO43571_Poster | 1 |
| Recruitment arrangements (for publication) | K2. Recruitment Material_Final Script for Spanish Patient Video | 1 |
| Recruitment arrangements (for publication) | K2. Recruitment Material_Link Youtube _Que es un ensayo clinico | 1 |
| Recruitment arrangements (for publication) | K2. Recruitment Material_Transcript_Video What is a Clinical Research Study Spanish | 1 |
| Recruitment arrangements (for publication) | K3_Poster | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment materials_Poster | 1 |
| Recruitment arrangements (for publication) | Reclutamiento Sujetos_v1_2022_02_02_Redacted | 1 |
| Recruitment arrangements (for publication) | ReclutamientoSujetos_v2_2022_03_14_Redacted | 2 |
| Recruitment arrangements (for publication) | Recruitment and Informed Consent Procedure - WO43571 POLAND 20220222 clean_Redacted | 2 |
| Subject information and informed consent form (for publication) | BPI-SF_v2_EN | 2 |
| Subject information and informed consent form (for publication) | BR23 HU v1 | 1 |
| Subject information and informed consent form (for publication) | BR23 Italian | 1 |
| Subject information and informed consent form (for publication) | Complete Consent Security and Privacy Overview V1 1 12-Nov-2021 | 1.0 |
| Subject information and informed consent form (for publication) | Cover Page_HU version for cycle 1_18_36 and EOT_Pink | 2 |
| Subject information and informed consent form (for publication) | Cover Page_HU version for cycle 2_4_5_Purple | 2 |
| Subject information and informed consent form (for publication) | Cover Page_HU version for cycle 3_9_15_39_48_57_66_75_84_Green | 2 |
| Subject information and informed consent form (for publication) | Cover Page_HU version for cycle 54_72_90 | 2 |
| Subject information and informed consent form (for publication) | Cover Page_HU version for follow up 1_2_3_4_5 year_Orange | 2 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Greenphire_Messaging_Templates_Direct_Deposit_EN | 6.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Greenphire_Messaging_Templates_Direct_Deposit_FR | 6.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Greenphire_Messaging_Templates_Direct_Deposit_NL | 6.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Greenphire_Reimbursement_Information_Sheet_EN | 8.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Greenphire_Reimbursement_Information_Sheet_FR | 8.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Greenphire_Reimbursement_Information_Sheet_NL | 8.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Infant_Authorization_Form_BE_EN | 1.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Infant_Authorization_Form_BE_FR | 1.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Infant_Authorization_Form_BE_NL | 1.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Informed_Consent_Form_Procedure_Redacted | 1 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_NTF_PROs_Redacted | 1 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Patient_Diary_EN | 2 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Patient_Diary_FR | 2 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Patient_Diary_NL | 2 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Patient_Participation_Card_EN | 1.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Patient_Participation_Card_FR | 1.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Patient_Participation_Card_NL | 1.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_PPA_BE_EN | 1.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_PPA_BE_FR | 1.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_PPA_BE_NL | 1.0 |
| Subject information and informed consent form (for publication) | CTR_2022-500014-26-00_Sponsor_Statement_On_Use_Of_ICF_Mode | 1 |
| Subject information and informed consent form (for publication) | eConsent Optimized Submission_Additional Information | 1.0 |
| Subject information and informed consent form (for publication) | Effective_Portugal Portuguese EQ-5D-5L Paper Self-Complete v1 4 | 1.4 |
| Subject information and informed consent form (for publication) | EQ-5D-5L | 1 |
| Subject information and informed consent form (for publication) | EQ-5D-5L HU v1 | 1 |
| Subject information and informed consent form (for publication) | GP5_HU_v4_28Jul2009 | 4 |
| Subject information and informed consent form (for publication) | GP5_ITA_Final_Ver4_NI_28Jul09 | 1 |
| Subject information and informed consent form (for publication) | GP5_POR_Final_Ver4_NI_23Aug16 | 4 |
| Subject information and informed consent form (for publication) | ICF General WO43571_V1_2022_02_03_glosary_ES | 1 |
| Subject information and informed consent form (for publication) | ICF General_WO43571_ES_CC | 1 |
| Subject information and informed consent form (for publication) | ICF General_WO43571_V2_2022_04_04_ES | 1 |
| Subject information and informed consent form (for publication) | ICF General_WO43571_V2_2022_04_04_ES_CC | 1 |
| Subject information and informed consent form (for publication) | ICF Home Nursing_WO43571_ES | 4 |
| Subject information and informed consent form (for publication) | ICF Home Nursing_WO43571_V2_2022_04_04_ES | 1 |
| Subject information and informed consent form (for publication) | ICF Home Nursing_WO43571_V2_2022_04_04_ES_CC | 1 |
| Subject information and informed consent form (for publication) | ICF Home Nursing_WO43571_V3_2022_04_25_ES_CC | 1 |
| Subject information and informed consent form (for publication) | ICF RBR_WO43571_ V2_2022_04_04_ES | 1 |
| Subject information and informed consent form (for publication) | ICF RBR_WO43571_ V2_2022_04_04_ES_CC | 1 |
| Subject information and informed consent form (for publication) | ICF RBR_WO43571_ V3_2022_04_25_ES_CC | 1 |
| Subject information and informed consent form (for publication) | ICF WO43571 Genetic_redacted | 1.1 |
| Subject information and informed consent form (for publication) | ICF WO43571 pertuzumab + trastuzumab_PT_v1 1 | 1.0 |
| Subject information and informed consent form (for publication) | ICF WO43571 pertuzumab trastuzumab_Mobile Nursing_PT_CTIS_Final | 1.1 |
| Subject information and informed consent form (for publication) | ICF WO43571 RBR_PT_redacted | 1.1 |
| Subject information and informed consent form (for publication) | ICF WO43571 V1_ Home Nursing_2022_02_03_ES | 1 |
| Subject information and informed consent form (for publication) | ICF_IAF_WO43571_V2_2022_04_04_ES | 1 |
| Subject information and informed consent form (for publication) | ICF_IAF_WO43571_V2_2022_04_04_ES_CC | 1 |
| Subject information and informed consent form (for publication) | ICF_IAF_WO43571_V3_2022_04_25_ES_CC | 1 |
| Subject information and informed consent form (for publication) | ICF_PPA_WO43571_V2_2022_04_04_ES | 1 |
| Subject information and informed consent form (for publication) | ICF_PPA_WO43571_V2_2022_04_04_ES_CC | 1 |
| Subject information and informed consent form (for publication) | ICF_PPA_WO43571_V3_2022_04_25_ES_CC | 1 |
| Subject information and informed consent form (for publication) | L1_ICF WO43571_Genetic_PT_RUS | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF WO43571_Main_PT_RUS | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF WO43571_Main_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF WO43571_RBR_PT_RUS | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker Sheet_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker Sheet_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker Sheet_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_UA | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_EN_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_FR_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_NL_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_REDACTED | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_UA | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN_WO43571_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing ICF_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing ICF_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing ICF_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing Polish | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_Polish | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_UA | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Blue Cycles EN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Blue Cycles FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Blue Cycles NL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Green Cycles EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Green Cycles FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Green Cycles NL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Orange Cycles EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Orange Cycles FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Orange Cycles NL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Pink Cycles EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Pink Cycles FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Pink Cycles NL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Purple Cycles EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Purple Cycles FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page Purple Cycles NL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page White Cycles_EN | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page White Cycles_FR | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PRO Cover Page White Cycles_NL | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR ICF_FR_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR_Polish | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR_UA | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR_WO43571_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ IAF PPA_Polish | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Biomarker Sheet Clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RU_clean | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Mobile nursing_Clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Principal_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and RBR ICF_EN_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and RBR ICF_NL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF WO43571_General_redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF WO43571_RBR_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_backtraslation ICF General_REDACTED | 7 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_backtraslation ICF RBR_REDACTED | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_IAF_WO43571 | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_PPA_WO43571 | 3 |
| Subject information and informed consent form (for publication) | L2_Communication Study Info To Doctors | 1 |
| Subject information and informed consent form (for publication) | L2_ePRO_QLQ BR23_PT | 1 |
| Subject information and informed consent form (for publication) | L2_Lay CTD_EN | 4.0 |
| Subject information and informed consent form (for publication) | L2_Lay_CTD_EN | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Biomarker sheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Diary | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Thank You Card | 1 |
| Subject information and informed consent form (for publication) | L2_Poster_EN | 1 |
| Subject information and informed consent form (for publication) | L2_Poster_FR | 1 |
| Subject information and informed consent form (for publication) | L2_Poster_NL | 1 |
| Subject information and informed consent form (for publication) | L2_Prohibited Medication List_EN_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L2_Prohibited Medication List_FR_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L2_Prohibited Medication List_NL_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L2_Referral Letter | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_GDPR | 2 |
| Subject information and informed consent form (for publication) | L2_WO43571_Biomarker Sheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_WO43571_Biomarker Sheet_ES | 1 |
| Subject information and informed consent form (for publication) | L2_WO43571_ePRO_Russian For Portugal | 1 |
| Subject information and informed consent form (for publication) | L2_WO43571_Patient Diary_PT_RUS | 2 |
| Subject information and informed consent form (for publication) | L2_WO43571_Patient Participation Card_PT_RUS | 1 |
| Subject information and informed consent form (for publication) | L3_Biomarker Sheet | 1 |
| Subject information and informed consent form (for publication) | L3_Recruitment and ICF Procedure | 1 |
| Subject information and informed consent form (for publication) | Portugal_-_EC_packet_w_Data_Privacy_as_applied_to_GP_v7 0 | 7.0 |
| Subject information and informed consent form (for publication) | Portugal_Greenphire ClinCard Travel Ref Guide for Subjects V4 0 jan22 | 4.0 |
| Subject information and informed consent form (for publication) | Portuguese Portugal - Greenphire ClinCard Msg Templates - ROW v6 0 Feb 2018 | 6.0 |
| Subject information and informed consent form (for publication) | Portuguese Portugal - Greenphire Travel Contact Card v2 0 July 2016 | 2.0 |
| Subject information and informed consent form (for publication) | Portuguese Portugal - Greenphire_ClinCard_Cardholder_FAQ_EU_V3 0 | 3.0 |
| Subject information and informed consent form (for publication) | Portuguese Portugal - Greenphire_Fee_Schedule_V4 0 | 4.0 |
| Subject information and informed consent form (for publication) | Portuguese Portugal Greenphire_ClinCard_Card_Carrier_EU_V3 0 | 3 |
| Subject information and informed consent form (for publication) | PPA WO43571 pertuzumab + trastuzumab IAF_PT | 1.0 |
| Subject information and informed consent form (for publication) | PPA WO43571 pertuzumab + trastuzumab_PT | 1.0 |
| Subject information and informed consent form (for publication) | PPA WO43571_V1_2022_02_03_ES | 1 |
| Subject information and informed consent form (for publication) | PRO CTCAE_HU_v1_11Jan2022 | 1 |
| Subject information and informed consent form (for publication) | pro-ctcae | 1 |
| Subject information and informed consent form (for publication) | pro-ctcae_portuguese-portugal_61dd8316 | 1.0 |
| Subject information and informed consent form (for publication) | QLQ-C30 HU v3 | 3 |
| Subject information and informed consent form (for publication) | QLQ-C30 Italian | 3.1 |
| Subject information and informed consent form (for publication) | QLQ-C30 Portuguese Portugal 1 3 | 3.0 |
| Subject information and informed consent form (for publication) | Reimbursement Information Sheet_EU_PT | 1.2 |
| Subject information and informed consent form (for publication) | Roche WO43571 Mobile Clinical Services Guidance for Sites v2 0_05Jul2022 | 1.0 |
| Subject information and informed consent form (for publication) | SIS and ICF Adult | 5 |
| Subject information and informed consent form (for publication) | Summary for patient materials updated with SM13 | RFI SM13 |
| Subject information and informed consent form (for publication) | Template - Greenphire EU Generic ClinCard v3 0 April 2019 | 3.0 |
| Subject information and informed consent form (for publication) | W043571_eConsent_PT_Introduction | 1.0 |
| Subject information and informed consent form (for publication) | W043571_eConsent_PT_Introduction_PrintScreen | 1.0 |
| Subject information and informed consent form (for publication) | WO43571 - Cover Page_Italian version for Italy | 2 |
| Subject information and informed consent form (for publication) | WO43571 - Cover Page_Italian version for Italy_Blue | 1 |
| Subject information and informed consent form (for publication) | WO43571 - Cover Page_Italian version for Italy_Green | 2 |
| Subject information and informed consent form (for publication) | WO43571 - Cover Page_Italian version for Italy_Orange | 2 |
| Subject information and informed consent form (for publication) | WO43571 - Cover Page_Italian version for Italy_Pink | 2 |
| Subject information and informed consent form (for publication) | WO43571 - Cover Page_Italian version for Italy_Purple | 2 |
| Subject information and informed consent form (for publication) | WO43571 GP Letter | NA |
| Subject information and informed consent form (for publication) | WO43571 GP Letter Track Changes | NA |
| Subject information and informed consent form (for publication) | WO43571 ICF RBR v1_2022_02_03_ES | 1 |
| Subject information and informed consent form (for publication) | WO43571 Infant form e Informativa privacy v1 del 08 Febbraio 2022 | 1 |
| Subject information and informed consent form (for publication) | WO43571 Info Privacy_Testimone-caregiver-vol sano-rappr legale_IT_01Lug2021 | 1 |
| Subject information and informed consent form (for publication) | WO43571 Patient Diary HU | 2 |
| Subject information and informed consent form (for publication) | WO43571 Patient Participation Card V1 18Febr2022 | 1 |
| Subject information and informed consent form (for publication) | WO43571 PPA v 1 del 08 Febbraio 2022 | 1 |
| Subject information and informed consent form (for publication) | WO43571 Terhesseggel kapcsolatos tajekoztato es beleegyezo nyilatkozat_v1_22Feb2022 | 1 |
| Subject information and informed consent form (for publication) | WO43571 Ujszulottel kapcsolatos tajekoztato es beleegyezo nyilatkozat_v1_22Feb2022 | 1 |
| Subject information and informed consent form (for publication) | WO43571 Valaszhato Roche Biobank_betegtajekoztato es beleegyezo nyilatkozat_v2_04May2022 | 2 |
| Subject information and informed consent form (for publication) | WO43571 Valaszthato otthonapolasi vizit_betegtajekoztato es beleegyezo nyilatkozat_v1_22Feb2022 | 1 |
| Subject information and informed consent form (for publication) | WO43571_DEU_Patient Card_V1_20220216 | 1 |
| Subject information and informed consent form (for publication) | WO43571_DEU_Patient Diary _Arm B_Giredestrant capsule | 2 |
| Subject information and informed consent form (for publication) | WO43571_DEU_Patient Material_Cool bags for IMP transfer_Redacted | 1 |
| Subject information and informed consent form (for publication) | WO43571_DEU_PRO_questionnaires inclusive paper booklet coversheets | 2 |
| Subject information and informed consent form (for publication) | WO43571_eConsent_Genetic | 1.0 |
| Subject information and informed consent form (for publication) | WO43571_eConsent_Genetic_PrintScreen | 1.0 |
| Subject information and informed consent form (for publication) | WO43571_eConsent_Primary ICF | 1.0 |
| Subject information and informed consent form (for publication) | WO43571_eConsent_Primary ICF_PrintScreen | 1.0 |
| Subject information and informed consent form (for publication) | WO43571_eConsent_RBR | 1.0 |
| Subject information and informed consent form (for publication) | WO43571_eConsent_RBR_PrintScreen | 1.0 |
| Subject information and informed consent form (for publication) | WO43571_heredERA_Patient Diary V1 0 | 1.0 |
| Subject information and informed consent form (for publication) | WO43571_heredERA_Patient Diary_Giredestrant capsule | 2 |
| Subject information and informed consent form (for publication) | WO43571_heredERA_Patient Diary_PT | 2.0 |
| Subject information and informed consent form (for publication) | WO43571_heredERA_Patient Participation Card V1 0_26-Jan-2022 | 1 |
| Subject information and informed consent form (for publication) | WO43571_heredERA_Patient Participation Card_PT | 1.0 |
| Subject information and informed consent form (for publication) | WO43571_heredERA_Trial Video Caption_German version | 1 |
| Subject information and informed consent form (for publication) | WO43571_heredERA_Trial Video Scipt_German version | 1 |
| Subject information and informed consent form (for publication) | WO43571_IAF_V1_2022_02_03_ES | 1 |
| Subject information and informed consent form (for publication) | WO43571_Patient Video Script_Hu_v1_Final | 1 |
| Subject information and informed consent form (for publication) | WO43571-BPI-SF_Italy | 1 |
| Subject information and informed consent form (for publication) | WO43571-BPI-SF_WorstPainItem_Portuguese_Portugal | 1 |
| Subject information and informed consent form (for publication) | WPAI GH_HU | 1 |
| Subject information and informed consent form (for publication) | WPAI-GH__Italian-Italy_ pdf | 1 |
| Subject information and informed consent form (for publication) | WPAI-GH-Portuguese__Portugal__v1 4 | 1.4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_de-2022-500014-26-00 | 3.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_de-be-2022-500014-26-00 | 3.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_en-2022-500014-26-00 | 3.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_es-2022-500014-26-00 | 3.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr-2022-500014-26-00 | 3.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr-be-2022-500014-26-00 | 5.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_hu-2022-500014-26-00 | 3.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_it-2022-500014-26-00 | 3.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_nl-be-2022-500014-26-00 | 5.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pl-2022-500014-26-00 | 3.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pt-2022-500014-26-00 | 3.0 |
| Synopsis of the protocol (for publication) | WO43571_Protocol Synopsis in lay language v1_02Feb2022_FR-BE | 1 |
| Synopsis of the protocol (for publication) | WO43571_Protocol Synopsis in lay language v1_02Feb2022_NL-BE | 1 |
Application history
24 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-02-24 | Germany | Acceptable 2022-06-14
|
2022-06-16 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2022-06-22 | Acceptable 2022-06-14
|
2022-07-07 | |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2022-07-06 | Acceptable 2022-06-14
|
2022-07-14 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2022-07-15 | Germany | Acceptable 2022-06-14
|
2022-07-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-07-28 | Germany | Acceptable 2022-11-07
|
2022-11-07 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2022-12-21 | Germany | Acceptable 2023-04-11
|
2023-04-11 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2023-06-07 | Acceptable 2023-04-11
|
2023-06-07 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2023-06-29 | Germany | Acceptable 2023-04-11
|
2023-06-29 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2023-07-26 | Germany | Acceptable 2023-04-11
|
2023-07-26 |
| 10 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-09-21 | Germany | Acceptable 2024-01-10
|
2024-01-11 |
| 11 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-01-29 | Acceptable | 2024-03-08 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-02-12 | Acceptable | 2024-04-05 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-02-13 | Acceptable | 2024-03-20 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-02-19 | Germany | Acceptable | 2024-03-15 |
| 15 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-02-27 | Acceptable | 2024-03-26 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-03-14 | Acceptable | 2024-05-31 | |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2024-06-03 | 2024-06-03 | ||
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-11 | 2024-09-05 | 2024-09-05 | ||
| 19 | SUBSTANTIAL MODIFICATION | SM-13 | 2024-10-31 | Germany | Acceptable 2024-12-17
|
2024-12-18 |
| 20 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-03-06 | Germany | Acceptable | 2025-03-11 |
| 21 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-04-01 | Acceptable | 2025-06-13 | |
| 22 | SUBSTANTIAL MODIFICATION | SM-17 | 2025-07-31 | Germany | Acceptable 2025-09-10
|
2025-09-11 |
| 23 | SUBSTANTIAL MODIFICATION | SM-18 | 2025-11-21 | Germany | Acceptable 2026-01-27
|
2026-01-27 |
| 24 | SUBSTANTIAL MODIFICATION | SM-19 | 2026-03-19 | Acceptable | 2026-04-20 |