Titre A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) in Combination With Paclitaxel and Multiple Novel Oncology Therapies and Durvalumab (MEDI4736) + Paclitaxel for First-line Metastatic Triple Negative Breast Cancer.
Protocole ID BEGONIA
ClinicalTrials.gov ID NCT03742102
Type(s) de cancer Sein
Phase Phase I-II
Stade Métastatique
Type étude Traitement
Institution CISSS DE LA MONTEREGIE-CENTRE
   HOPITAL CHARLES-LE MOYNE
      3120 boulevard Taschereau, Greenfield Park, QC, J4V2H1
Ville Greenfield Park
Investigateur(trice) principal(e) Dre Catherine Prady
Coordonnateur(trice) Stéphanie Bonin
 450-466-5000 poste 7691
Statut Fermé
Critètes d'éligibilité
  • Female
  • At least 18 years of age at the time of screening
  • Patient must have locally confirmed TNBC
  • No prior treatment for metastatic (Stage IV) TNBC
  • Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured
  • WHO/ECOG status at 0 or 1 at enrollment
Critètes d'exclusion
  • History of venous thromboembolism in the past 3 months
  • Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment
  • History of allogeneic organ transplantation
  • Active or prior documented autoimmune or inflammatory disorders
  • Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies)
  • Untreated CNS metastases
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
  • Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment
  • Female patients who are pregnant or breastfeeding