Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab
- Conditions
- Triple Negative Breast Neoplasms
- Interventions
- Registration Number
- NCT02926196
- Lead Sponsor
- Istituto Oncologico Veneto IRCCS
- Brief Summary
Phase III randomized trial of the anti-PD-L1 antibody avelumab as adjuvant or post-neoadjuvant treatment for high-risk triple negative breast cancer patients. The overall protocol-defined patient population will include the following two strata of patients:
* Stratum A - Patients who have completed treatment with curative intent including surgery of the primary tumor followed by adjuvant chemotherapy .
* Stratum B - Patients who have completed treatment with curative intent including neoadjuvant chemotherapy followed by surgery of the primary tumor and (if indicated) further adjuvant chemotherapy.
- Detailed Description
* to determine whether 1 year of adjuvant Avelumab improves disease-free survival (DFS) compared to observation in patients with high-risk primary triple negative breast cancer who have completed treatment with curative intent including surgery of the primary tumor and neo- or adjuvant chemotherapy (Stratum A \[surgery of the primary tumor followed by adjuvant chemotherapy\] and Stratum B \[neoadjuvant chemotherapy followed by surgery\] combined).
* to determine whether 1 year of adjuvant Avelumab improves disease-free survival (DFS) compared to observation in patients with high-risk primary triple negative breast cancer who have completed treatment with curative intent including neoadjuvant chemotherapy followed by surgery (Stratum B).
* to determine whether Avelumab improves overall survival (OS) compared to observation in patients with high-risk primary triple negative breast cancer who have completed treatment with curative intent including surgery of the primary tumor and neo- or adjuvant chemotherapy.
* to determine whether 1 year of adjuvant Avelumab improves disease-free survival (DFS) compared to observation in PD-L1-positive (as determined by a companion diagnostic test under development) patients with high-risk primary triple negative breast cancer who have completed treatment with curative intent including surgery of the primary tumor and neo- or adjuvant chemotherapy.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 474
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm Avelumab MSB0010718C Avelumab 10 mg/kg I.V. q2w for 1 year (52 weeks)
- Primary Outcome Measures
Name Time Method Disease free survival Up to 5 years after randomization DFS is defined as the time from randomization to locoregional invasive recurrence, second primary invasive breast cancer, other second primary cancer (excluding in-situ cancers), distant metastasis or death from any cause.
Disease free survival in PD-L1-positive patients Up to 5 years after randomization DFS is defined as the time from randomization to locoregional invasive recurrence, second primary invasive breast cancer, other second primary cancer (excluding in-situ cancers), distant metastasis or death from any cause.
- Secondary Outcome Measures
Name Time Method Overall survival Up to 5 years after randomization Overall survival is defined as the time from randomization to death from any cause
Safety profile From Baseline up to 5 years after randomization Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI -CTCAE), version 4.
Trial Locations
- Locations (70)
Ospedale di Bergamo
🇮🇹Bergamo, BG, Italy
Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, BO, Italy
Ospedale di Bellaria
🇮🇹Bologna, BO, Italy
Azienda Sanitaria Locale Brindisi
🇮🇹Brindisi, BR, Italy
Azienda Spedali Civili di Brescia
🇮🇹Brescia, BS, Italy
A.S.O. S.Croce e Carle di Cuneo
🇮🇹Cuneo, CN, Italy
AOU Policlinico "Vittorio. Emanuele
🇮🇹Catania, CT, Italy
ARNAS Garibaldi,
🇮🇹Catania, CT, Italy
Arcispedale S. Anna
🇮🇹Cona, FE, Italy
AOU San Martino IST Istituto Nazionale per la Ricerca sul Cancro IRCCS
🇮🇹Genova, GE, Italy
Ospedale Misericordia di Grosseto
🇮🇹Grosseto, GR, Italy
ASL Lucca
🇮🇹Lucca, LU, Italy
Istituto Nazionale dei Tumori IRCCS
🇮🇹Milano, MI, Italy
Ospedale Ramazzini
🇮🇹Carpi, MO, Italy
Azienda Ospedaliero-Universitaria di Modena - Policlinico
🇮🇹Modena, MO, Italy
AOU Policlinico di Palermo
🇮🇹Palermo, PA, Italy
Ospedale di Camposampiero
🇮🇹Camposampiero, PD, Italy
Istituto Oncologico Veneto IRCCS
🇮🇹Padova, PD, Italy
Centro di Riferimento Oncologico di Aviano (CRO)
🇮🇹Aviano, PN, Italy
AUSL 4
🇮🇹Prato, PO, Italy
Azienda Ospedaliera Universitaria di Parma
🇮🇹Parma, PR, Italy
CROB-IRCCS di Rionero in Vulture
🇮🇹Rionero in Vulture, PZ, Italy
IRCCS - Azienda Ospedaliera S.M. Nuova
🇮🇹Reggio Emilia, RE, Italy
Ospedale Civile Santa Chiara
🇮🇹Trento, TN, Italy
I.R.C.C.S. - Fondazione del Piemonte per l'Oncologia
🇮🇹Candiolo, TO, Italy
Ospedale di Castelfranco Veneto
🇮🇹Castelfranco Veneto, TV, Italy
Azienda ULSS 9 - Ca Foncello
🇮🇹Treviso, TV, Italy
A. O. U. Santa Maria della Misericordia
🇮🇹Udine, UD, Italy
Ospedale di Mirano
🇮🇹Mirano, VE, Italy
Ospedale Sacro Cuore - Don Calabria
🇮🇹Negrar, VR, Italy
Policlinico G.B. Rossi
🇮🇹Verona, VR, Italy
Clinica Oncologica-Ospedali Riuniti Ancona
🇮🇹Ancona, Italy
Azienda Sanitaria Locale Di Asti
🇮🇹Asti, Italy
Ospedale Centrale Di Bolzano
🇮🇹Bolzano, Italy
Ospedale Dell'Ulss N. 1 Belluno- Ospedale S. Martino Belluno
🇮🇹Belluno, Italy
P.O. Clinicizz. 'Ss. Annunziata' Chieti
🇮🇹Chieti, Italy
Asst Lariana
🇮🇹Como, Italy
A.O. Istituti Ospedalieri - Cremona
🇮🇹Cremona, Italy
Azienda Unità Sanitaria Locale della Romagna
🇮🇹Faenza-Ravenna-Lugo, Italy
Ospedale San Salvatore
🇮🇹L'Aquila, Italy
Ospedale Lecce - 'V Fazzi' (San Cesario)- Opedale Lecce - 'V.Fazzi'
🇮🇹Lecce, Italy
Ospedale di Livorno
🇮🇹Livorno, Italy
UOC Oncologia ASUR AV3 Macerata
🇮🇹Macerata, Italy
I.R.S.T. Srl Irccs
🇮🇹Meldola, Italy
AOR Papardo
🇮🇹Messina, Italy
Ospedale dell'Angelo
🇮🇹Mestre, Italy
Azienda Ospedaliera Universitaria Federico Ii
🇮🇹Napoli, Italy
Istituto Nazionale Tumori - Fondazione Pascale,
🇮🇹Napoli, Italy
AOU Maggiore della Carità - SC Oncologia Novara
🇮🇹Novara, Italy
.O. Ospedali Riuniti Marche Nord- Ospedale San Salvatore - Pesaro
🇮🇹Pesaro Fano, Italy
Ospedale "Guglielmo Da Saliceto" Piacenza
🇮🇹Piacenza, Italy
Azienda Ospedaliero-Universitaria Pisana
🇮🇹Pisa, Italy
Azienda Ospedaliera Regionale 'S. Carlo'- Ospedale San Carlo Di Potenza
🇮🇹Potenza, Italy
Presidio Ospedaliero Rimini-Santarcangel- Ospedale "Infermi" Rimini
🇮🇹Rimini, Italy
Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata
🇮🇹Roma, Italy
Ifo - Istituto Nazionale Tumori Regina Elena (Ire)
🇮🇹Roma, Italy
Ospedale Fatebenefratelli
🇮🇹Roma, Italy
Policlinico Universitario Campus Biomedico
🇮🇹Roma, Italy
U.O.C. di Oncologia Medica Interpresidio PO S.Pertini-S Eugenio-CTO Roma
🇮🇹Roma, Italy
UOC Oncologia Osp. S.Andrea Un. La Sapienza Roma
🇮🇹Roma, Italy
Ao Citta' Della Salute E Della Scienza D- Osp.S. Giov.Battista Molinette
🇮🇹Torino, Italy
Ospedale Di Circolo E Fondazione Macchi - Varese
🇮🇹Varese, Italy
Royal United Hospitals Bath NHS Foundation Trust
🇬🇧Bath, United Kingdom
Blackpool Teaching Hospital
🇬🇧Blackpool, United Kingdom
Raigmore Hospital
🇬🇧Inverness, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
St Bartholomew's Hospital
🇬🇧London, United Kingdom
Hillingdon Hospitals NHS Foundation Trust and Mount Vernon Cancer Centre
🇬🇧Northwood, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom