Phase II Study of Afatinib for Patients with Persistent or Returning HER2-positive Uterine Serous Carcinoma

Sponsor: Yale University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02491099

Provider View

This clinical trial is testing the effectiveness of the drug Afatinib in patients with uterine serous carcinoma that is persistent or has returned and shows high levels of HER2. The study aims to see if patients can live without the cancer getting worse for at least 6 months after starting treatment.

Patient Parameters

Program Overview

The main goal of this study is to see if Afatinib can help patients with persistent or returning uterine serous carcinoma that has high levels of HER2 live without their cancer worsening for at least 6 months. The study will also look at how many patients respond to the treatment, how long the disease can be controlled, overall survival rates, and the safety of Afatinib in these patients.

Description

This study is exploring the use of Afatinib in treating uterine serous carcinoma with high HER2 levels. Researchers will evaluate how well the drug works by looking at the HER2 levels in patients and seeing if there is a connection between these levels and the response to treatment. They will also study other genetic factors that might affect how well the treatment works. The study will monitor changes in HER2 levels in the blood and the activity of certain immune cells to understand how Afatinib might help fight the cancer. The study will also assess the safety of Afatinib and its effects on patients' overall health.

Eligibility Criteria

Inclusion Criteria

  • Have persistent or returning uterine serous carcinoma confirmed by a pathologist, with high HER2 levels.
  • Have measurable cancer that can be tracked during the study.
  • Have had surgery and have measurable cancer remaining.
  • Have good bone marrow function and specific blood counts.
  • Have a performance status of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
  • Have signed a consent form and recovered from recent treatments.
  • May have had previous chemotherapy or trastuzumab treatment, with a 2-week break before starting Afatinib.
  • Women of childbearing age must have a negative pregnancy test and use effective contraception.
  • Be at least 18 years old.
  • Can have other cancers if they don't interfere with this study. Patients with prior anthracycline exposure are not eligible.

Exclusion Criteria

  • Have a history of serious heart problems, uncontrolled high blood pressure, or other unstable medical conditions within 6 months.
  • Have active infections or require IV antibiotics.
  • Have brain involvement or active neurological diseases.
  • Have received certain types of cancer drugs before.
  • Have uncontrolled seizures or are HIV positive with active hepatitis.
  • Have bleeding disorders.

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