Spots Global Cancer Trial Database for Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab
Official Title: Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab: A Phase III Randomized Trial. Sponsor: Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche, Università di Padova
Study ID: NCT02926196
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Azienda ULSS n. 5 Ovest Vicentino, Montecchio Maggiore, VI, 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 Dell'Ulss N. 1 Belluno- Ospedale S. Martino Belluno, Belluno, , Italy
Ospedale Centrale Di Bolzano, Bolzano, , 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
ASST Valtellina e Alto Lario- SC Oncologia Medica Ospedale di Sondrio, Sondrio, , 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
Contact Details
Name: Valentina Guarneri, Prof
Affiliation: University of Padua and Istituto Oncologico Veneto
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
