Titre A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy
Protocole ID KATE3
ClinicalTrials.gov ID NCT04740918
Type(s) de cancer Sein
Phase Phase III
Stade Maladie avancée ou métastatique
Type étude Clinique
Médicament Trastuzumab emtansine en association avec l'atézolizumab ou un placebo
Institution CENTRE UNIVERSITAIRE DE SANTE MCGILL
   SITE GLEN
      1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville Montréal
Investigateur(trice) principal(e) Dr Jamil Asselah
Coordonnateur(trice) Soizic Durocher
514-934-1934 poste 36674
Statut Actif en recrutement
Critètes d'éligibilité
  • HER2+ and PD-L1+ locally advanced (LABC) or metastatic breast cancer (MBC)
  • Progression must have occurred during most recent treatment for LABC/MBC or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy
  • Prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting
  • No more than two prior lines of therapy in the metastatic setting
  • Measurable disease per RESIST version 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy >= 6 months
  • Adequate hematologic and end-organ function
  • For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs
  • For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
Critètes d'exclusion
  • Prior treatment with trastuzumab emtansine in metastatic setting
  • History of exposure to cumulative doses of anthracyclines
  • Symptomatic or actively progressing central nervous system (CNS) metastases; asymptomatic CNS lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated CNS lesions are eligible
  • Current Grade >= 3 peripheral neuropathy
  • Cardiopulmonary dysfunction
  • History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation and malignancies with a negligible risk of metastasis or death
  • History of leptomeningeal disease
  • Active or history of autoimmune disease or immune deficiency
  • Active hepatitis B, hepatitis C and/or tuberculosis
  • Prior allogeneic stem cell or solid organ transplantation
  • Receipt of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, during treatment, or within 5 months following the last dose of study treatment
  • Pregnancy or lactation