RecruitingPhase 2

A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma

United States50 participantsStarted 2015-06

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 adenocarcinoma in the specimen. * Have adequate bone marrow function. * WBC greater than or equal to 3,000/ul, platelets greater than or equal to 75,000/ul, neutrophils greater than or equal to 1500/ul., creatinine less than or equal to 2.0 mg/kl, bilirubin \< 1.5 X laboratory normal, SGOT/SGPT \<3 X laboratory normal. * Have an ECOG performance status of 0 or 1. * Have signed an approved consent. * Have recovered from effects of recent surgery, radiotherapy or chemotherapy. Should be free of significant infection. * Patients with recurrent disease may have received multiple prior chemotherapies for treatment of their uterine cancer. * May have received prior trastuzumab therapy alone or in combination with chemotherapy with 2 week washout period required between trastuzumab treatment and first dose of Afatanib. * Patients of childbearing potential must have a negative serum pregnancy test within 7 d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression free survival

Timeframe: 4 Years

Trial details

NCT IDNCT02491099

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Alessandro D. Santin, M.D.

203-737-4450 alessandro.santin@yale.edu

View on ClinicalTrials.gov More HER2/Neu+ Uterine Serous Carcinoma trials