Randomized Comparative Prospective Multicentre Phase II Trial Evaluating Clinical Impact of Interruption VS Maintenance of AI in Patients with Locally Advanced/ Metastatic LGESS
The primary objective is to compare the progression-free survival (PFS) between aromatase inhibitors interruption and aromatase inhibitors maintenance strategies in patients with a locally advanced or metastatic Low Grade Endometrial Stromal Sarcoma (LGESS).
• Age≥18 years;
• Histological confirmation of low grade ESS;
• Locally advanced or metastatic disease at diagnosis or patient experiencing a tumor effraction during hysterectomy;
• Treatment with aromatase inhibitors (Anastrozole or Exemestane or Letrozole ) initiated either: for at least 24 months (in patients with no residual disease or non-measurable disease at the last AI initiation) OR for at least 36 months (in patients with measurable disease at the last AI initiation);
• Disease must be controlled at the time of the randomisation (objective response or stable disease) by the aromatase inhibitor initiated either for at least 24 or 36 months
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
• Covered by a medical insurance;
• Signed informed consent prior to any study-specific procedure.