A Phase II Trial of Ribociclib (LEE011) plus Letrozole in Women with Recurrent Low-Grade Serous Carcinoma of the Ovary, Fallopian Tube or Peritoneum
The study evaluates the response to treatment with Ribociclib and Letrozole in patients with low grade serous cancer of the ovary, fallopian tube or peritoneum.
Primary Objective: To determine the response rate of patients receiving the combination of letrozole + Ribociclib. Secondary Objectives: To determine the clinical benefit (CR, PR, and SD) rate of patients receiving the combination of letrozole + Ribociclib. To determine the nature, frequency, and maximum degree of toxicity associated with this combination using CTCAE v5.0. To determine the progression-free survival of women receiving the combination of letrozole + Ribociclib. To determine the overall survival of women receiving the combination of letrozole + Ribociclib. Exploratory Objectives: To determine the expression of estrogen receptor (ER), progesterone receptor (PR), and proliferative index (ki-67) and their correlation with response and clinical benefit. To determine genomic signatures associated with response and clinical benefit of the combination of letrozole + Ribociclib.
Femara (Letrozole); LEE011 (Ribociclib); Letrozole (); Ribociclib ()
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