Actively Recruiting
A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma
Led by Yale University · Updated on 2025-10-09
50
Participants Needed
3
Research Sites
682 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Persistent or recurrent uterine serous carcinoma confirmed by histology
- Tumor overexpresses HER2/neu with IHC score 3+ or 2+ plus confirmed gene amplification by FISH
- Measurable disease with at least one target lesion per RECIST v1.1
- May have had surgery (optimal or suboptimal debulking) with measurable recurrent disease
- Histology shows more than 10% uterine papillary serous adenocarcinoma
- Adequate bone marrow function: WBC 3,000/ul, platelets 75,000/ul, neutrophils 1500/ul
- Kidney and liver function within specified limits
- ECOG performance status 0 or 1
- Signed informed consent
- Recovered from recent surgery, radiotherapy, or chemotherapy with no significant infection
- Prior multiple chemotherapies allowed
- Prior trastuzumab allowed with 2-week washout before Afatinib
- Negative pregnancy test within 7 days if of childbearing potential and using effective contraception
- Aged 18 years or older
- Prior or concurrent malignancies allowed if not interfering with study, but no prior anthracycline exposure
You will not qualify if you...
- History of significant cardiac disease or uncontrolled heart conditions within 6 months
- Unstable medical issues or active serious infections requiring IV antibiotics
- Brain or leptomeningeal disease involvement
- Active neurological disease, dementia, or uncontrolled seizure disorder
- Prior treatment with irreversible human epidermal growth factor receptor tyrosine kinase inhibitors
- Known HIV seropositive or active hepatitis
- Known bleeding disorders or active bleeding
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Trial Site Locations
Total: 3 locations
1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
Completed
2
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Completed
Research Team
A
Alessandro D. Santin, M.D.
CONTACT
L
Lisa Baker, R.N.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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