Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
450
Countries
5
Sites
70
Endocrine-Sensitive phosphatidylinositol 3-kinase (PIK3CA)-Mutated, Hormone Receptor-Positive, human epidermal growth factor receptor 2- (HER2-) negative advanced breast cancer
To evaluate the efficacy of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole compared with placebo plus a CDK4/6i and letrozole with respect to time from randomization to the first occurrence of disease progression
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
- 14 Jul 2025 → ongoing
- Decision date (initial)
- 2025-04-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche Ltd
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Others, Safety
To evaluate the efficacy of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole compared with placebo plus a CDK4/6i and letrozole with respect to time from randomization to the first occurrence of disease progression
Secondary objectives 5
- To evaluate the efficacy of inavolisib plus a CDK4/6i and letrozole compared with placebo plus a CDK4/6i and letrozole with respect to time from randomization to death from any cause
- To evaluate the efficacy of inavolisib plus a CDK4/6i and letrozole compared with placebo plus a CDK4/6i and letrozole with respect to Investigator-assessed (confirmed ORR, DOR, CBR)
- To evaluate patient-reported pain severity, functioning, and health-related quality of life (HRQoL) among participants treated with inavolisib plus a CDK4/6i and letrozole compared with placebo plus a CDK4/6i and letrozole
- To evaluate the safety of inavolisib plus a CDK4/6i and letrozole compared with placebo plus a CDK4/6i and letrozole
- To evaluate the tolerability of inavolisib plus a CDK4/6i and letrozole compared with placebo plus a CDK4/6i and letrozole from the participant's perspective
Conditions and MedDRA coding
Endocrine-Sensitive phosphatidylinositol 3-kinase (PIK3CA)-Mutated, Hormone Receptor-Positive, human epidermal growth factor receptor 2- (HER2-) negative advanced breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10072737 | Advanced breast cancer | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | WO45654 - Phase III, double-blind, inavolisib plus CDK4/6 inhibitor and letrozole vs placebo This is a phase III, multicentre, randomised, double-blind, placebo-controlled study to evaluate efficacy and safety of inavolisib plus CDK4/6 inhibitor and letrozole vs placebo in HER-2 negative advanced breast cancer.
|
Randomised Controlled | Double | [{"id":181578,"code":2,"name":"Investigator"},{"id":181577,"code":3,"name":"Monitor"},{"id":181579,"code":1,"name":"Subject"}] | Arm A: inavolisib plus palbociclib Arm B: letrozole or placebo plus palbociclib and letrozole |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- N/A
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-505812-39-00 | A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients with PIK3CA -Mutant, Hormone Receptor-Positive, HER2 -Negative Locally Advanced or Metastatic Breast Cancer | F. Hoffmann-La Roche AG |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- De-novo hormone receptor-positive (HR +) , HER2- advanced breast cancer (ABC), or, alternatively, relapsed HR + , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy – If a CDK4/6i was included as part of that early breast cancer treatment, progression must not have occurred during or within 1 year of last receipt of the CDK4/6i
- Confirmation of biomarker eligibility: valid results from either central testing of blood or pre-existing local testing of blood or tumor tissue documenting the presence of a study-eligible PIK3CA-mutation.
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- Men or women of postmenopausal or premenopausal/perimenopausal status
- For men (and women of pre-/peri-menopausal status: willingness to undergo and maintain treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy for the duration of study treatment
- Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Exclusion criteria 6
- Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer
- Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., patients with visceral crisis)
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Inability or unwillingness to swallow pills
- Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
- History of malignancy within 5 years prior to consent, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Time from randomization to the first occurrence of disease progression, as determined by the investigator according to response evaluation criteria in solid tumors, Version 1.1 (RECIST v1.1), or death from any cause (whichever occurs first)
Secondary endpoints 14
- 1. Time from randomization to death from any cause
- 2. Investigator-assessed confirmed objective response rate (ORR), defined as the proportion of participants with a complete response (CR) and/or partial response (PR) on at least two consecutive ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1
- 3. Investigator-assessed duration of response (DOR), defined as the time from the first occurrence of a confirmed objective response to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)
- 4. Investigator-assessed clinical benefit rate (CBR), defined as the proportion of participants with a CR, PR, and/or stable Disease (SD) for at least 24 weeks, as determined by the investigator according to RECIST v1.1
- 5. Time to confirmed deterioration (TTCD) in pain, defined as the time from randomization to the first documentation of a ≥ 2-point increase from baseline held for two consecutive timepoints on the "worst pain" item from the Brief Pain Inventory-Short Form (BPI-SF)
- 6. TTCD in Physical Function, defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive timepoints on the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) Physical Function scale (items 1-5)
- 7. TTCD in Role Function, defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive timepoints on the EORTC QLQ-C30 Role Function scale (items 6 and 7)
- 8. TTCD in HRQoL, defined as the time from randomization to the first documentation of a ≥ 10- point decrease from baseline held for two consecutive timepoints on the EORTC QLQ-30 GHS/QoL scale (items 29 and 30)
- 9. Incidence and severity of adverse events, with severity determined according to the national cancer institute common terminology criteria for adverse events (NCI CTCAE) v5.0
- 10. Change from baseline in targeted vital signs
- 11. Change from baseline in targeted clinical laboratory test results
- 12. Presence, frequency of occurrence, severity, and/or degree of interference with daily activities of symptomatic treatment toxicities (i.e., diarrhea, nausea, vomiting, decreased appetite, fatigue, mouth sores, rash, muscle pain, joint pain, hot flashes and vaginal dryness), as assessed through use of the National Cancer Institute Patient Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) instrument
- 13. Proportion of participants reporting each response option at each assessment timepoint by treatment arm for treatment side-effect bother single-item General Population, Question 5 (GP5) from the functional assessment of cancer therapy-general questionnaire (FACT-G)
- 14. Change from baseline in symptomatic treatment toxicities and treatment side-effect bother as assessed through use of the PRO-CTCAE and FACT-G GP5 item, respectively
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 13
PRD9793811 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 0.29 g gram(s)
- Max treatment duration
- 30 Month(s)
- 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
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 0.29 g gram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
SUB08444MIG · Substance
- Active substance
- Letrozole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 2.28 g gram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use.
LETROZOLE ACCORD HEALTHCARE 2,5 mg, comprimé pelliculé
PRD4609615 · Product
- Active substance
- Letrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 2.28 g gram(s)
- Max treatment duration
- 30 Month(s)
- 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
- Relabeled for clinical trial use.
Letrozol STADA® 2,5 mg Filmtabletten
PRD389191 · Product
- Active substance
- Letrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 2.28 g gram(s)
- Max treatment duration
- 30 Month(s)
- 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
- Relabeled for clinical trial use.
SUB177204 · Substance
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 84 g gram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trial use.
IBRANCE 75 mg film-coated tablets
PRD7907995 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 84 g gram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/010
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trial use.
IBRANCE 125 mg film-coated tablets
PRD7907865 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 84 g gram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/014
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trial use.
IBRANCE 100 mg film-coated tablets
PRD7907867 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 84 g gram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/012
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trial use.
SUB177204 · Substance
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 84 g gram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use.
SUB177204 · Substance
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 84 g gram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for CT use.
SUB180246 · Substance
- Active substance
- Ribociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 403.2 g gram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trial use.
SUB180246 · Substance
- Active substance
- Ribociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 403.2 g gram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeled for clinical trial use.
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
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 8
| Organisation | City, country | Duties |
|---|---|---|
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Other |
| Median Technologies ORG-100041462
|
Valbonne, France | Other |
| Foundation Medicine Inc. ORG-100040457
|
Boston, United States | Other |
| Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd. ORG-100043119
|
Shanghai, China | Other |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Madison, United States | Other |
| Foundation Medicine GmbH ORG-100040499
|
Penzberg, Germany | Other |
Locations
5 EU/EEA countries · 70 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 35 | 12 |
| Germany | Ongoing, recruiting | 28 | 16 |
| Italy | Ongoing, recruiting | 53 | 17 |
| Poland | Ongoing, recruiting | 25 | 10 |
| Spain | Ongoing, recruiting | 35 | 15 |
| Rest of world
Mexico, Japan, Turkey, Australia, Korea, Republic of, Canada, Taiwan, United States, Argentina, Switzerland, China, Brazil, South Africa, United Kingdom
|
— | 274 | — |
Investigational sites
Institut De Cancerologie De L Ouest
Oncologie Médicale, 15 Rue Andre Boquel, 49100, Angers
Centre Hospitalier Universitaire De Poitiers
Oncologie Médicale, 2 Rue De La Miletrie, 86000, Poitiers
Centre Oscar Lambret
Oncologie Médicale, 3 Rue Frederic Combemale, 59000, Lille
Oncopole Claudius Regaud
Oncologie Médicale, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Curie
Oncologie Médicale, 26 Rue D Ulm, 75005, Paris
Centre De Cancerologue Du Grand Montpellier
Oncologie Médicale, 25 Rue De Clementville, 34070, Montpellier
Centre De Lutte Contre Le Cancer Eugene Marquis
Oncologie Médicale, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
CARIO Centre Armoricain de Radiotherapie D'Imagerie medicale et D'Oncologie
Oncologie Médicale, 10 Rue Francois Jacob, 22190, Plerin
Institut Curie
Oncologie Médicale, 35 Rue Dailly, 92210, Saint-Cloud
Centre Henri Becquerel
Oncologie Médicale, Rue D Amiens, 76038, Rouen Cedex
Institut De Cancerologie De L Ouest
Oncologie Médicale, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Gustave Roussy
Oncologie Médicale, 114 Rue Edouard Vaillant, 94800, Villejuif
Klinikum Ernst von Bergmann gGmbH
N.A., Charlottenstrasse 72, Noerdliche Innenstadt, Potsdam
Universitaetsklinikum Essen AöR
Klinik für Frauenheilkunde und Geburtshilfe, Hufelandstrasse 55, Holsterhausen, Essen
Caritas Traegergesellschaft Saarbruecken mbH (CTS)
Frauenklinik Brustzentrum, Rheinstrasse 2, Malstatt, Saarbruecken
Institut Fuer Versorgungsforschung In Der Onkologie GbR
N.A., Neversstrasse 5, Sued, Koblenz
Mammazentrum Hamburg MVZ GbR
Brustklinik am Krankenhaus Jerusalem, Moorkamp 2-6, Eimsbuettel, Hamburg
Universitaet Muenster
Klinik für Frauenheilkunde und Geburtshilfe, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Medizinische Hochschule Hannover
Abteilung Gynäkologische Onkologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Technische Universitaet Dresden
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Gemeinschaftspraxis Fuer Haematologie Und Onkologie
N.A., Roentgenstrasse 6-8, 63225, Langen (Hessen)
Universitaetsklinikum Ulm AöR
Frauenklinik und Geburtshilfe, Prittwitzstrasse 43, Mitte, Ulm
National Center For Tumor Diseases (NCT) Heidelberg
Sektion Gynäkologische Onkologie, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
St. Elisabeth Krankenhaus GmbH
Brustzentrum, Werthmannstrasse 1, Lindenthal, Cologne
KEM I Evang. Kliniken Essen-Mitte gGmbH
N.A., Henricistrasse 92, Huttrop, Essen
Universitaetsklinikum Tuebingen AöR
Abteilung für Frauengesundheit, Calwerstrasse 7, Innenstadt, Tuebingen
Universitaetsklinikum Regensburg AöR
Klinik für Frauenheilkunde und Geburtshilfe, Landshuter Strasse 65, Kasernenviertel, Regensburg
Universitaetsklinikum Halle (Saale) AöR
Universitätsklinik und Poliklinik für Gynäkologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle Saale
Azienda Ospedaliera S Maria Di Terni
S.C. Oncologia, Viale Tristano Di Joannuccio 1, 05100, Terni
Pia Fondazione Di Culto E Religione Card G Panico
Oncology and palliative care department, Via Pio X 4, 73039, Tricase
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
S.S.D. Oncologia Medica - Zamagni, Via Pietro Albertoni 15, 40138, Bologna
IRCCS Istituto Nazionale Tumori Fondazione Pascale
U.O.C. Oncologia Clinica Sperimentale di Senologia, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliero Universitaria Di Modena
S.C. Oncologia, COM, Largo Del Pozzo 71, 41124, Modena
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O.S.D. Medicina di Precisione in Senologia, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Sant'anna E San Sebastiano Di Caserta
U.O.C. Oncologia Medica a Direzione Universitaria, Via Ferdinando Palasciano Snc, 81100, Caserta
Humanitas Istituto Clinico Catanese S.p.A.
Oncologia, Strada Provinciale 54 Contrada Cubba 11, 95045, Misterbianco
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
S.C. Oncologia, Piazza Oms 1, 24127, Bergamo
Ospedale San Raffaele S.r.l.
U.O. Oncologia Medica, Via Olgettina 60, 20132, Milan
Central Hospital Of Bolzano
U.O.C. Oncologia Medica, Via Lorenz Boehler 5, 39100, Bolzano
Azienda Ospedaliera Universitaria Federico II Di Napoli
U.O.C. Oncologia Medica, Via Sergio Pansini 5, 80131, Naples
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliero-Universitaria Maggiore Della Carita
S.C.D.U. Oncologia, Corso Giuseppe Mazzini 18, 28100, Novara
Humanitas Mirasole S.p.A.
Breast Oncology Unit, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
U.O.C. Oncologia Medica Livorno, Via Antonio Cocchi 7/9, 56121, Pisa
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Oddział Onkologii Klinicznej i Chemioterapii, Pl. Ludwika Hirszfelda 12, 53-413, Wroclaw
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym i Izbą Przyjęć, Ul. Garbary 15, 61-866, Poznan
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddział Onkologii Klinicznej, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Przychodnia Lekarska KOMED Roman Karaszewski
n/a, Wojska Polskiego 6, 62-500, Konin
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Oddział Onkologii Klinicznej, Ul. Ogrodowa 12, 15-027, Bialystok
Instytut Centrum Zdrowia Matki Polki
Klinika Onkologii, Ul. Rzgowska 281/289, 93-338, Lodz
Mruk-Med I Sp. z o.o.
n/a, Ul. Gen. Mariana Langiewicza 61, 35-021, Rzeszow
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddział Dzienny Chemioterapii, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Szpital Miejski Specjalistyczny Im. Gabriela Narutowicza W Krakowie
Oddział Kliniczny Onkologii Klinicznej i Chemioterapii, Ul. Pradnicka 35-37, 31-202, Cracow
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Virgen De La Victoria
Oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital General Universitario De Elche
Oncology, Edificio 2, Camino De La Almazara 11, Elche
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario De La Princesa
Oncology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario De Navarra
Oncology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Beata Maria Ana
Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital Universitario Basurto
Oncology, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital Universitario Infanta Leonor
Oncology, Avenida Gran Via Del Este 80, 28031, Madrid
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
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 | 2025-08-21 | 2025-09-04 | |||
| Germany | 2025-08-13 | 2025-09-05 | |||
| Italy | 2025-07-14 | 2025-07-23 | |||
| Poland | 2025-07-14 | 2025-07-21 | |||
| Spain | 2025-07-21 | 2025-09-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 54 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_protocol-2024-516162-11-00-redacted | 2 |
| Protocol (for publication) | d4_patient-facing-documents_memo | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements _WO45654 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_ES | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_WO45654 | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_WO45654_track change | 1.0 |
| Recruitment arrangements (for publication) | K2_reccruitment arrangement_HCP Referral Letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material leaflet | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Social Media Post_WO45654 | 1 |
| Recruitment arrangements (for publication) | K3_Document_additionnel_WO45654_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF IAF | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF PPA | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Prescreening RBR | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Prescreening_REDACTED | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF RBR | 3 |
| Subject information and informed consent form (for publication) | L1_Privacy consent form other subjects | 1.1 |
| Subject information and informed consent form (for publication) | L1_Privacy consent form patient_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biposy | 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 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF prescreening_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF principal_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MAIN_WO45654_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Partner_WO45654 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Partner_WO45654_track change | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Patient_WO45654 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Patient_WO45654_track change | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening_WO45654_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening_WO45654_track change | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_WO45654_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_WO45654_track change | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS ICF principal_clean_FINAL_Unredacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF WO45654_Prescreening_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF RBR _WO45654_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF RBR prescreening _WO45654_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_general _WO45654_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_IAF _WO45654 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_PPA _WO45654 | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-letrozole | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-palbociclib | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-ribociclib | N/A |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_eng-2024-516162-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_es-2024-516162-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr-fr-2024-516162-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_it-2024-516162-11-00 | 2 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pl-2024-516162-11-00 | 2 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-16 | Germany | Acceptable 2025-04-04
|
2025-04-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-22 | Germany | Acceptable 2025-07-10
|
2025-07-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-30 | Germany | Acceptable | 2025-08-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-20 | Acceptable | 2025-11-10 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-24 | Germany | Acceptable 2026-02-25
|
2026-02-25 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-10 | Germany | Acceptable 2026-02-25
|
2026-03-10 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-05-05 | Acceptable | 2026-05-27 |