Titre A Phase III, Multicenter, Randomized Placebo-Controlled Study of Atezolizumab (MPDL3280A) (Anti-PD-L1 Antibody) in Combination With Nab Paclitaxel Compared With Placebo With Nab Paclitaxel for Patients With Previously Untreated Metastatic Triple Negative Breast Cancer
Protocole ID WO29522
ClinicalTrials.gov ID NCT02425891
Type(s) de cancer Sein
Phase Phase III
Type étude Traitement
Médicament Atezolizumab (MPDL3280A) avec Nab Paclitaxel
Institution CHU DE QUEBEC – UNIVERSITE LAVAL
   HOPITAL DU SAINT-SACREMENT
      1050 Ch Ste-Foy, Québec, QC, G1S 4L8
Ville Québec
Investigateur(trice) principal(e) Dre Louise Provencher
Coordonnateur(trice) Isabelle Ouellet
 418-682-7511 poste 4553
Statut Fermé
Critètes d'éligibilité
  • Female > or = 18 years of age
  • Metastatic or locally advanced, histologically documented Triple-Negative Breast Cancer (TNBC)
  • No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Measurable disease
  • Adequate hematologic and end-organ function
Critètes d'exclusion
  • Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
  • Leptomeningeal disease
  • Pregnancy or lactation
  • History of autoimmune disease
  • Prior allogeneic stem cell or solid organ transplantation
  • Positive test for HIV
  • Active hepatitis B or hepatitis C