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A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer - BIG 16-05/AFT-27/WO39391

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

- Signed Informed Consent Form (ICF)
- Ability to comply with protocol, in the investigator's judgment
- Women or men aged ≥ 18 years at time of signing ICF
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Non-metastatic operable Stage II-III breast cancer
- Histologically documented TNBC (Triple Negative Breast Cancer)
- Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen
- Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
- No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization.
- Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides.

Criteri di esclusione: 

- Prior history of invasive breast cancer
- For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy.
- Previous therapy with anthracyclines or taxanes for any malignancy
- Cardiopulmonary dysfunction
- Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Urinary outflow obstruction
- Active tuberculosis
- Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment or within 5 months following the last dose of Atezolizumab (for patients randomized to Atezolizumab)
- Prior allogeneic stem cell or solid organ transplant
- Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study

Trattamento sperimentale: 

Atezolizumab + Chemotherapy

Trattamento di controllo: 

Chemotherapy

Obiettivi primari dello studio: 

Invasive Disease-Free Survival (iDFS) [Time Frame: Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years).]
iDFS events are defined as follows:
- Ipsilateral invasive breast tumor recurrence
- Ipsilateral local-regional invasive breast cancer recurrence
- Ipsilateral second primary invasive breast cancer
- Contralateral invasive breast cancer
- Distant recurrence
- Death attributable to any cause

Centri partecipanti

Nord Italia

SC Oncologia ASO SS Antonio e Biagio e C. Arrigo
Via Venezia 16 - 15100 Alessandria - AL

 

Ospedale Papa Giovanni XXIII Bergamo
Piazza OMS 1 - 24127 Bergamo - BG

 

A.O. Ospedale degli Infermi
Via dei Ponderanesi 2 - 13875 Ponderano - BI
Reparto Oncologia Medica

 

A.O. Ospedale degli Infermi
Via dei Ponderanesi 2 - 13875 Ponderano - BI
Reparto Oncologia Medica

 

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
UO Farmacia Clinica

 

Azienda Ospedaliero Universitaria di Ferrara
Via Aldo Moro 8 - 44124 Cona - FE
UO di Oncologia

Riferimento: Prof. Antonio Frassoldati
Telefono: 0532237138
Email: a.frassoldati@ospfe.it

 

E.O. OSPEDALI GALLIERA - GENOVA
Via Mura delle Cappuccine 14 - 16128 Genova - GE

 

IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE

 

ASST Lecco - PO Alessandro Manzoni
Via Dell'Eremo 9 - 23900 Lecco - LC
Oncologia Medica

Riferimento: Dr. Antonio Ardizzoia
Telefono: 0341489900
Email: a.ardizzoia@asst-lecco.it

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Dr. Marco Colleoni
Telefono: 0257489970
Email: marco.colleoni@ieo.it

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

Riferimento: Prof. Armando Santoro
Telefono: 0282246280
Email: armando.santoro@cancercenter.humanitas.it

 

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO

 

Policlinico di Monza
Via Carlo Amati 111 - 20900 Monza - MB

Riferimento: Prof. Emilio Bajetta
Email: emilio.bajetta@policlinicodimonza.it

 

Azienda Ospedaliero-Universitaria di Parma
Via Gramsci 14 - 43126 Parma - PR

Riferimento: Dr. Antonino Musolino
Telefono: 0521702660
Email: amusolino@ao.pr.it

 

Fondazione Salvatore Maugeri-IRCCS
Via Salvatore Maugeri 4 - 27100 Pavia - PV
Unità di Oncologia Medica - ICS Maugeri, via S. Maugeri 10

 

IRCCS Policlinico San Matteo
Viale Golgi 19 - 27100 Pavia - PV

Riferimento: Prof. Paolo Pedrazzoli
Telefono: 0382501659
Email: p.pedrazzoli@smatteo.pv.it

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN
SOC Oncologia Medica C

 

Presidio Ospedaliero di Faenza
Viale Stradone 9 - 48018 Faenza - RA
Ospedale degli Infermi - Oncologia Medica

 

Azienda Ospedaliera Santa Maria della Misericordia
Piazzale Santa Maria della Misericordia 15 - 33100 Udine - UD

 

A.U.L.S.S. 9 Legnago
Via Gianella 1 - 37045 Legnago - VR
Ospedale Mater Salutis

 

Centro Italia

AOU di Perugia Santa Maria della Misericordia
Via Enrico dal Pozzo 1 - 06123 Perugia - PG

 

Nuovo Ospedale di Prato
Via Suor Niccolina Infermiera 20 - 59100 Prato - PO

Riferimento: Dr.ssa Laura Biganzoli
Telefono: 0574802520
Email: laura.biganzoli@uslcentro.toscana.it

 

Università Campus Bio-medico
Via Álvaro del Portillo 200 - 00128 Roma - RM

 

Ospedale Belcolle
Strada Sammartinese - 01100 Viterbo - VT
Oncologia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2016-003695-47

Data di inserimento: 11.03.2019

Data di aggiornamento: 25.06.2020

Promotore

F. Hoffmann-La Roche Ltd

CRO

PRAHEALTHSCIENCES

Principal Investigator ITALIA

Istituto Europeo di Oncologia, Milano

Riferimento: Dr. Marco Angelo Colleoni

Telefono: 0257489970

Email: marco.colleoni@ieo.it

Localita: Milano

 

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