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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

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

Riferimento: Dr.ssa Elena Seles
Telefono: 01515157503

 

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

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

 

A.U.L.S.S. 21 Legnago
Via Gianella 1 - 37045 Legnago - VR

Riferimento: Dr. Andrea Bonetti
Telefono: 0442622624
Email: andrea.bonetti@aulsslegnago.it

 

Centro Italia

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

Riferimento: Dr.ssa Anna Maria Mosconi
Telefono: 0755784207
Email: annamaria.mosconi@ospedale.perugia.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2016-003695-47

Data di inserimento: 11.03.2019

Promotore

F. Hoffmann-La Roche Ltd

CRO

/

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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