A Phase II Evaluation of Afatinib
Corpus Uteri | Other Female Genital
What is the purpose of this trial?
- To assess the activity of afatinib in patients with persistent or recurrent USC overexpressing HER2/neu with the frequency of patients who survive progression-free for at least 6 months after initiating therapy. b.
- To assess objective response rate (ORR) and durable disease control rate (DDCR),
- To assess overall survival (OS)
- To assess the safety profile of afatinib in USC patients
- To systematically evaluate HER2/neu expression/amplification using standardized scoring criteria for both breast and gastric cancer and correlate clinical response in EC patients with HER2/neu scoring results.
- To correlate ORR, PFS, and OS with the presence/absence of PIK3CA (phosphatidyl inositol 3-kinase catalytic subunit) and FBXW7 (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 treated with Afatinib
- HER2/neu extracellular domain (ECD) circulating levels in the plasma of USC patients overexpressing HER2/neu before, and during Afatinib treatment to elucidate whether changes in HER2/neu ECD would predict response to Afatinib and
- To determine peripheral blood natural killer (NK) cell numbers and activity in HER2/neu+ USC patients before, and during Afatinib treatment to assess the possible therapeutic contributions of immune mechanisms of action of Afatinib.
- Ages18 years and younger
- GenderFemale only
- Trial withYale Cancer Center
- Start Date05/17/2015
- End Date06/29/2023
- Last Updated01/03/2019
- Study HIC#1503015437