Titre A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GDC-0077 Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
Protocole ID WO41554
ClinicalTrials.gov ID NCT04191499
Type(s) de cancer Sein
Phase Phase III
Stade Maladie avancée ou métastatique
Type étude Traitement
Médicament GDC-0077 + Palbociclib et Fulvestrant vs Placebo + Palbociclib et Fulvestrant
      1050 Ch Ste-Foy, Québec, QC, G1S 4L8
Ville Québec
Investigateur(trice) principal(e) Dr Éric Poirier
Coordonnateur(trice) Fanie Bourgault
 418-525-4444 poste 82697
Statut Actif en recrutement
Critètes d'éligibilité
  • Confirmed diagnosis of HR+/HER2- breast cancer
  • Metastatic or locally advanced disease not amenable to curative therapy
  • Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
  • Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
  • Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
  • Consent to provide fresh or archival tumor tissue specimen
  • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1; "bone-only" disease, even if considered measurable, is not eligible
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Life expectancy of > 6 months
  • Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Critètes d'exclusion
  • Metaplastic breast cancer
  • Any history of leptomeningeal disease or carcinomatous meningitis
  • Any prior systemic therapy for metastatic breast cancer
  • Prior treatment with fulvestrant or any selective estrogen-receptor degrader
  • Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
  • Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
  • Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases are eligible
  • Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
  • Symptomatic active lung disease, or requiring daily supplemental oxygen
  • History of inflammatory bowel disease or active bowel inflammation
  • Anti-cancer therapy within 2 weeks before study entry
  • Investigational drug(s) within 4 weeks before randomization
  • Prior radiotherapy to >= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
  • Chronic corticosteroid therapy or immunosuppressants
  • Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment
  • Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1