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
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.
Description
Exploratory/correlative objectives: To systematically evaluate HER2/neu expression/amplification using standardized scoring criteria for both breast and gastric cancer and correlate clinical response in uterine serous carcinoma patients with HER2/neu scoring results. To correlate objective response rate, PFS and overall survival with the presence/absence of phosphatidyl inositol 3-kinase catalytic subunit and F-box/WD repeat-containing protein mutations by standard Sanger sequencing, and presence/absence of Cyclin E2 overexpression by IHC in endometrial cancer patients overexpressing HER2/neu…
Eligibility
- Age range
- 18–100 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have persistent or recurrent histologically confirmed uterine serous carcinoma, harbor a tumor HER2/neu+ based upon IHC staining score of 3+ or 2+ with confirmed gene amplification by FISH. * Have measurable disease. * Have at least one target lesion to be used to assess response as defined by RECIST v1.1. * After undergoing surgery may be optimally or sub optimally debulked, with measurable recurrent disease of any previous substage. * Diagnosis histologically confirmed by a gynecologic pathologist as containing \>10% uterine papillary serous adenocarcinom…
Interventions
- DrugAfatinib
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 CenterTucson, Arizona
- Yale New Haven HospitalNew Haven, Connecticut
- Massachusetts General HospitalBoston, Massachusetts