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A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma
Sponsor: Yale University
Summary
Primary Objective: To assess the activity of Afatinib in patients with persistent or recurrent uterine serous carcinoma overexpressing HER2/neu with the frequency of patients who survive progression-free for at least 6 months after initiating therapy. Secondary Objectives: To assess objective response rate and durable disease control rate. To assess overall survival. To assess the safety profile of Afatinib in uterine serous carcinoma patients.
Official title: A Phase II Evaluation of Afatanib, an Irreversible Human Epidermal Growth Factor Receptor 2 (Her2/Neu) Tyrosine Kinase Inhibitor, in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma
Key Details
Gender
FEMALE
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2015-06
Completion Date
2028-07
Last Updated
2025-10-09
Healthy Volunteers
No
Conditions
Interventions
Afatinib
Afatinib, 40 mg orally once daily on a 21 day cycle for the first 12 weeks, then every 28 days for subsequent cycles until progression
Locations (3)
University of Arizona Cancer Center
Tucson, Arizona, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Massachusetts General Hospital
Boston, Massachusetts, United States