Titre A Double-Blind Placebo-Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
Protocole ID MA.40 (Finer)
ClinicalTrials.gov ID NCT04650581
Type(s) de cancer Sein
Phase Phase III
Type étude Clinique
Médicament Fulvestrant and Ipatasertib
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 Christine Desbiens
Coordonnateur(trice) Fanie Bourgault
418-525-4444 poste 82697
Statut Actif en recrutement
Critètes d'éligibilité
  • Histologically and/or cytologically confirmed ER positive, HER-2 negative breast cancer
  • Female patients must be post-menopausal; female patients who are pre-menopausal must have ovarian suppression using LHRH agonist while on study
  • Clinical and/or radiographic progression during treatment with or within 28 days after discontinuation of first line of treatment with a CDK 4/6 inhibitor and an aromatase inhibitor (AI) for advanced/metastatic disease
  • Evidence of clinically and/or radiologically documented disease
  • ≥ 18 years of age
  • ECOG performance status of 0 or 1
  • No concurrent anti-cancer therapy and must satisfy the following criteria for previous therapy
    • Must not have received more than one prior line of treatment with a CDK 4/6 inhibitor and an AI in the advanced disease setting.
    • Treatment with CDK 4/6 inhibitor and AI must have been the most recent treatment prior to registration for this study
  • Adequate hematology and organ function, in the absence of growth factors
    • Absolute neutrophils > 1.5 x 10^9/L
    • Platelets ≥ 100 x 10^9/L
    • Hemoglobin > 90 g/L
    • Total Bilirubin ≤ 1.5 x ULN (upper limit of normal) or ≤ 3 x ULN if confirmed Gilbert's Syndrome
    • ALT and AST ≤ 2.5 x ULN (or ≤ 5.0 x ULN if liver or bone metastasis)
    • Alkaline phosphatase ≤ 2.0 x ULN (or ≤ 5.0 x ULN if liver metastases, ≤ 7.0 x ULN if bone metastasis)
    • Fasting glucose ≤ 8.3 mmol/L
    • HbA1c ≤ 7.5%
    • Serum albumin ≥ 30 g/L
    • INR ≤ 1.2
    • Serum Creatinine or Creatinine clearance ≤ 1.5 x ULN or ≥ 50 mL/min; measured directly by 24-hour urine sampling or as calculated by Crockcroft and Gault equation
Critètes d'exclusion
  • Untreated or symptomatic CNS metastases, radiation treatment for CNS metastases within 28 days
  • Active inflammatory bowel disease, bowel inflammation, inability to swallow oral medication or GI condition that alters oral absorption
  • Prior treatment with fulvestrant, selective estrogen receptor degraders (SERDs) or known inhibitors of the PI3K pathway including PI3K inhibitors, AKT inhibitors, or mTOR inhibitors
  • Mean QT interval corrected for heart rate (QTc) ≥ 480 msec by ECG or history of familial long QT syndrome
  • Active or uncontrolled infections or serious illnesses or medical conditions
  • Clinically significant liver diseases
  • History of lung disease or history of opportunistic infections
  • Type 1 or Type 2 diabetes mellitus requiring insulin
  • Grade ≥ 2 uncontrolled hypercholesterolemia or hypertriglyceridemia
  • Known abnormalities in coagulation
  • History of hypersensitivity to the study drugs or components
  • Pregnant or lactating women