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Clinical Trial 20336
Cancer Type: Gynecological Tumor
Study Type: Treatment
NCT#: NCT03673124
Phase: Phase II
Prinicipal Investigator: Hye Sook Chon
Study Title
A Phase II Trial of Ribociclib (LEE011) plus Letrozole in Women with Recurrent Low-Grade Serous Carcinoma of the Ovary, Fallopian Tube or Peritoneum
Summary
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.
Objective
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.
Therapies
Medications
Femara (Letrozole); LEE011 (Ribociclib); Letrozole (); Ribociclib ()
EXCLUSION CRITIERIA:
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