Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
325
Countries
3
Sites
10
Metastatic breast cancer, including triple negative breast cancer (TNBC), hormone receptor positive breast cancer (HR+ BC), and HER2 positive and HER2 low breast cancer (HER2+/HER2-low BC)
Stage 1 •To evaluate the efficacy of treatment combinations during Stage 1 based on objective response rate (ORR) •To evaluate the safety of treatment combinations during Stage 1 based on incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cance…
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
- 27 Jun 2018 → ongoing
- Decision date (initial)
- 2024-07-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche AG
External identifiers
- EU CT number
- 2023-503629-20-00
- EudraCT number
- 2017-002038-21
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
Stage 1
•To evaluate the efficacy of treatment combinations during Stage 1 based on objective response rate (ORR)
•To evaluate the safety of treatment combinations during Stage 1 based on incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0), changes from baseline in vital signs and electrocardiogram (ECG) parameters and change from baseline in targeted clinical laboratory test results.
Secondary objectives 2
- Stage 1 • To evaluate the efficacy of treatment combinations during Stage 1 based on progression-free survival (PFS), disease control rate (DCR), overall survival (OS), OS at specific timepoints and duration of response (DOR)
- Stage 2 • To evaluate the safety of treatment combinations during Stage 2
Conditions and MedDRA coding
Metastatic breast cancer, including triple negative breast cancer (TNBC), hormone receptor positive breast cancer (HR+ BC), and HER2 positive and HER2 low breast cancer (HER2+/HER2-low BC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10027475 | Metastatic breast cancer | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Age >/= 18 years at the time of signing Informed Consent Form
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Metastatic or inoperable locally advanced breast cancer
- Measurable disease (at least one target lesion) according to RECIST v1.1 (or, for Cohort 5 only, evaluable bone disease) For Cohort 5, patients with evaluable bone disease in the absence of measurable disease outside of the bone must have at least one predominantly lytic bone lesion confirmed by computed tomography (CT) or magnetic resonance imaging (MRI). Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.
- Life expectancy >/= 3 months, as determined by the investigator
- Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment
Exclusion criteria 6
- Adverse events from prior anti-cancer therapy that have not resolved to Grade </= 1 or better with the exception of alopecia of any grade and Grade </= 2 peripheral neuropathy
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Significant cardiovascular disease
- History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death Bilateral breast cancer is allowed if both cancers meet the inclusion criteria or the phenotypically different breast cancer meets the exception of more than 2 years prior to screening and negligible risk of metastasis or death at time of screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- Stage 1 1. ORR
- Stage 1 and 2 1. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to NCI CTCAE v4.0
- Stage 1 and 2 2. Change from baseline in vital signs and ECG parameters
- Stage 1 and 2 3. Change from baseline in targeted clinical laboratory test results
Secondary endpoints 5
- Stage 1 1. PFS
- Stage 1 2. DCR
- Stage 1 3. OS
- Stage 1 4. DOR
- Stage 1 5. OS at specific timepoints
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 30
Tecentriq 1 200 mg concentrate for solution for infusion
PRD5434939 · Product
- Active substance
- Atezolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FF05 — -
- Marketing authorisation
- EU/1/17/1220/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD5674603 · Product
- Active substance
- Atezolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Not Authorised
- MA holder
- ROCHE REGISTRATION LTD.
- Paediatric formulation
- No
- Orphan designation
- No
Fulvestrant EVER Pharma 250 mg Injektionslösung in einer Fertigspritze
PRD6824954 · Product
- Active substance
- Fulvestrant
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Authorisation status
- Authorised
- ATC code
- L02BA03 — FULVESTRANT
- Marketing authorisation
- 2201034.00.00
- MA holder
- EVER NEURO PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
FULVESTRANT ACCORD 250 mg, solution injectable en seringue pré-remplie
PRD7018817 · Product
- Active substance
- Fulvestrant
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Authorisation status
- Authorised
- ATC code
- L02BA03 — FULVESTRANT
- Marketing authorisation
- 34009 301 710 5 9
- MA holder
- ACCORD HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Faslodex 250 mg solution for injection.
PRD3545736 · Product
- Active substance
- Fulvestrant
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- 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
- No
Verzenios 150 mg film-coated tablets
PRD6701112 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/015
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Verzenios 100 mg film-coated tablets
PRD6701107 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/013
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Verzenios 50 mg film-coated tablets
PRD6701102 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/011
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9793130 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- 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
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9793132 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Kisqali 200 mg film-coated tablets
PRD5341538 · Product
- Active substance
- Ribociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L01EF02 — -
- Marketing authorisation
- EU/1/17/1221/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kisqali 200 mg film-coated tablets
PRD5341543 · Product
- Active substance
- Ribociclib
- Substance synonyms
- LEE011
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L01EF02 — -
- Marketing authorisation
- EU/1/17/1221/003
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kisqali 200 mg film-coated tablets
PRD5341551 · Product
- Active substance
- Ribociclib
- Substance synonyms
- LEE011
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L01EF02 — -
- Marketing authorisation
- EU/1/17/1221/005
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Abraxane 5 mg/ml powder for dispersion for infusion.
PRD9254301 · Product
- Active substance
- Paclitaxel Albumin-Bound
- Substance synonyms
- PACLITAXEL ALBUMINE-BOUND
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- EU/1/07/428/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
LETROZOLE ACCORD HEALTHCARE 2,5 mg, comprimé pelliculé
PRD4609615 · Product
- Active substance
- Letrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- 34009 394 393 7 2
- MA holder
- ACCORD HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-packaging and re-labelling for clinical trial use
Letrozol STADA® 2,5 mg Filmtabletten
PRD389191 · Product
- Active substance
- Letrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- 68973.00.00
- MA holder
- STADAPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-packaging and re-labelling for clinical trial use
—
SCP53436014 · ATC
- Route of administration
- INTRAVENIOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FX17 — SACITUZUMAB GOVITECAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RoActemra 20 mg/mL concentrate for solution for infusion
PRD2154622 · Product
- Active substance
- Tocilizumab
- Substance synonyms
- RO4877533, BIIB800, ATLIZUMAB, TOCILIZUMABUM
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Authorised
- ATC code
- L04AC07 — -
- Marketing authorisation
- EU/1/08/492/003
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6056703 · Product
- Active substance
- Tocilizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Not Authorised
- MA holder
- ROCHE REGISTRATION GMBH (RRG)
- Paediatric formulation
- No
- Orphan designation
- No
SUB35915 · Substance
- Active substance
- Empagliflozin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trials
SUB35915 · Substance
- Active substance
- Empagliflozin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trials
SUB177204 · Substance
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trials
SUB177204 · Substance
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trials
SUB177204 · Substance
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trials
SUB177204 · Substance
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trials
SUB177204 · Substance
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trials
SUB177204 · Substance
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trials
SUB08831MIG · Substance
- Active substance
- Metformin
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trials
PRD13142909 · Product
- Active substance
- Atirmociclib
- Substance synonyms
- PF-07220060, (3S,4R)-4-((5-chloro-4-(4-fluoro-2-(2-hydroxypropan-2-yl)-1-isopropyl-1Hbenzo[d]imidazol-6-yl)pyrimidin-2-yl)amino)tetrahydro-2H-pyran-3-ol
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- PFIZER LTD.
- Paediatric formulation
- No
- Orphan designation
- 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
- 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 |
|---|---|---|
| QPS Netherlands B.V. ORG-100009393
|
Groningen, Netherlands | Laboratory analysis |
| Foundation Medicine Inc. ORG-100040457
|
Cambridge, United States | Laboratory analysis |
| Discovery Life Sciences Biomarker Services GmbH ORG-100042520
|
Kassel, Germany | Laboratory analysis |
| Seagen Inc. ORG-100000606
|
Bothell, United States | Laboratory analysis |
| Fortrea Inc. ORG-100012602
|
Durham, United States | Other |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Other |
| Q Squared Solutions LLC ORG-100043195
|
Durham, United States | Laboratory analysis |
| Ventana Medical Systems Inc. ORG-100043193
|
Oro Valley, United States | Laboratory analysis |
| MicroCoat Biotechnologie GmbH ORG-100031937
|
Bernried Am Starnberger See, Germany | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Madison, United States | Laboratory analysis |
| Atrys Health S.A. ORG-100051425
|
Barcelona, Spain | Laboratory analysis |
Locations
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 23 | 3 |
| Germany | Ongoing, recruiting | 7 | 2 |
| Spain | Ongoing, recruiting | 26 | 5 |
| Rest of world
United Kingdom, Korea, Republic of, United States, Israel, Taiwan, Australia
|
— | 269 | — |
Investigational sites
Institut Universitaire Du Cancer Toulouse-Oncopole
Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Leon Berard
Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Universitaetsklinikum Essen AöR
NA, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Erlangen AöR
NA, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
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 |
|---|---|---|---|---|---|
| France | 2018-08-29 | 2018-10-11 | |||
| Germany | 2018-10-31 | 2019-01-25 | |||
| Spain | 2018-06-27 | 2018-07-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 60 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-503629-20-00 Redacted | 17 |
| Recruitment arrangements (for publication) | K1_Recruitment and Inform Consent | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent | NA |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent | NA |
| Subject information and informed consent form (for publication) | L1_Atezo Nab-Pac TCZ ICF_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Atezo_Nab_Pac Control ICF_red | 6.0 |
| Subject information and informed consent form (for publication) | L1_Atezo_Nab_Pac_TCZ ICF_red | 5.0 |
| Subject information and informed consent form (for publication) | L1_Biobanking _RBR_ ICF_Sanitized | 7.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_DE_SIS and ICF_Empa Inavo Fulv Palbo_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_DE_SIS and ICF_Empa Inavo Fulv_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_DE_SIS and ICF_Inavo Atirmo Fulv_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_DE_SIS and ICF_Inavo-Abema-Let_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_DE_SIS and ICF_Inavo-Ribo-Letr_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_DE_SIS and ICF_Infant Authorization_Sanitized | 3.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_DE_SIS and ICF_Metf Inavo Fulv Palbo_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_DE_SIS and ICF_Metf Inavo Fulv_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_SIS and ICF_Empa Inavo Fulv Palbo_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_SIS and ICF_Empa Inavo Fulv_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_SIS and ICF_Inavo Abema Letr_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_SIS and ICF_Inavo Atirmo Fulv_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_SIS and ICF_Inavo Ribo Letr_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_SIS and ICF_Infant Authorization_Sanitized | 1.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_SIS and ICF_Metf Inavo Fulv Palbo_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_CO40115_SIS and ICF_Metf Inavo Fulv_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Continue Treatment-Disease Worsening ICF _Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF_ScreenTx Assign_redacted | 22.0 |
| Subject information and informed consent form (for publication) | L1_Inavo Abema Fulv ICF_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_Inavo Ribo Fulv ICF_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Inavo_Abema_Fulv ICF_red | 3.0 |
| Subject information and informed consent form (for publication) | L1_Inavo_Abema_Fulv ICF_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_Inavo_Ribo_Fulv ICF_red | 4.0 |
| Subject information and informed consent form (for publication) | L1_Inavo_Ribo_Fulv ICF_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_Main Atezo SG ICF_red | 7.0 |
| Subject information and informed consent form (for publication) | L1_Mandatory biopsy ICF all arms_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_Optional Biopsies ICF_Sanitized | 9.0 |
| Subject information and informed consent form (for publication) | L1_Optional Biopsies ICF_sanitized | 10.0 |
| Subject information and informed consent form (for publication) | L1_Optional Biopsy ICF_Sanitized | 5.0 |
| Subject information and informed consent form (for publication) | L1_RBR ICF_Sanitized | 5.0 |
| Subject information and informed consent form (for publication) | L1_RBR ICF_sanitized | 9.0 |
| Subject information and informed consent form (for publication) | L1_Screen Tx ICF_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_Screening Main ICF_red | 16.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Empa Inavo Fulv Palbo_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Empa Inavo Fulv_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Inavo Atirmo Fulv_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Inavo-Abema-Letr_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Inavo-Ribo-Letr_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infant Authorization_Sanitized | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Metf Inavo Fulv Palbo_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Metf Inavo Fulv_Redacted | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-empagliflozin | NA |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-letrozole | NA |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-metformin | NA |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-palbociclib | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Abraxane | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Faslodex | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Kisqali | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Verzenios | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503629-20-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol-Synopsis_ES-2023-503629-20-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol-Synopsis_FR-2023-503629-20-00 | 1.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-02 | Germany | Acceptable 2024-06-12
|
2024-06-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-27 | Germany | Acceptable 2024-12-02
|
2024-12-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-24 | Germany | Acceptable with conditions 2025-05-19
|
2025-05-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-11 | Germany | Acceptable 2025-08-11
|
2025-08-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-05 | Germany | Acceptable 2026-03-30
|
2026-03-31 |