Maintenance Treatment with Letrozole Versus Placebo for Estrogen-Receptor Positive Epithelial Ovarian, Fallopian Tube, and Peritoneal Cancer A Phase III Randomized Double-Blind Study

What this Trial Is About

Researchers are evaluating the addition of letrozole, an aromatase inhibitor, to the standard maintenance therapy in women diagnosed with estrogen-receptor ER positive epithelial ovarian cancer, including fallopian tube and primary peritoneal cancer. This study focuses on both low and high grade serous or endometrioid ovarian cancers at FIGO Stage II-IV, whose cancer has not progressed after primary surgery and platinum-based chemotherapy. The main goal is to determine if letrozole can increase progression-free survival compared to the current standard maintenance treatment with placebo. Participants are randomly assigned to receive either letrozole 2.5 mg daily or a placebo tablet once daily for up to five years or until toxicity symptoms or disease progression occur. This randomized, double-blinded, multicenter phase III trial involves 540 eligible women who will be monitored throughout the treatment period. The study also includes a sub-study focusing on low grade ovarian cancer LOGOS. Treatment adherence and tolerability will be assessed during regular visits. Participants will undergo health assessments including blood tests, physical and gynecological exams, and possibly imaging during routine follow-ups every 12 weeks for the first two years, then every 24 weeks for three additional years. Quality of life will be evaluated using specific questionnaires, and participants will wear an activity tracker for one week before visits. Researchers will measure progression-free survival as the primary outcome and also evaluate overall survival, time to next treatment, and quality-adjusted survival. Follow-up data will be collected for up to 12 years, including up to seven years after treatment ends to monitor long-term outcomes.

MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)