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

{ "Phase II Afatinib for HER2-positive Uterine Serous Carcinoma", "This study is testing a drug called Afatinib in women with uterine serous carcinoma that has come back or continued to grow (persistent or recurrent) and has a specific marker called HER2/neu. Afatinib is given by mouth once a day. To join, your tumor must be HER2/neu positive and you must have measurable disease. The main goal is to see how many patients survive without their cancer growing for at least 6 months after starting Afatinib. Researchers will also look at how many patients respond to the treatment, how long they live, and the safety of Afatinib. This study plans to enroll 50 women, but the current status of enrollment is unclear.", "design": "This is an interventional study, meaning participants will receive a specific treatment. It is a Phase II study, and it plans to include 50 participants.", "commitments": "Afatinib is taken daily for 21 days, followed by a break, for the first 12 weeks. After that, it's taken every 28 days until the cancer grows.", "compensation": "Not stated in the trial record.", "follow_up": "The study will track how long participants live without their cancer growing for up to 4 years.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

PHASE2Ages 18+InterventionalTreatment

Yale University

~50 participants

Updated 2026-06-22 on ClinicalTrials.gov

What's tested:Afatinib

At a glance

Recruiting sites

1 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Progression free survival

Measured over 4 Years

Conditions

HER2/Neu+ Uterine Serous Carcinoma

Where it's being run

3 sites across 3 states

Arizona1

Connecticut1

Massachusetts1

Study leadership

Alessandro Santin, M.D. · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Alessandro D. Santin, M.D.

[email protected]

203-737-4450

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Eligibility criteria

Inclusion

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 days prior to the study entry and be practicing an effective form of contraception.

Must be 18 years of age.

Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. NOTE: Patients with prior anthracycline exposure are NOT eligible.

Exclusion

Patients who have a significant history of cardiac disease, uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmias within 6 months of registration. Patients with any unstable medical issue, active treatment for symptomatic pulmonary embolism, CVA, renal or hepatic insufficiency, active infection/sepsis requiring IV antibiotics, known brain/leptomengial involvement of the disease, active neurological disease, dementia.

Patients who have received prior therapy with any irreversible human epidermal growth factor receptor tyrosine kinase inhibitor.

Patients who have an uncontrolled seizure disorder or active neurological disease. Patients known to be seropositive for HIV and active hepatitis, even if liver function studies are in the eligible range. Known hemorrhagic diathesis or active bleeding disorder.

What this trial measures

Progression free survival4 Years
Progression free survival for at least 6 months after initiating therapy

Trialytics