Endoradiotherapy with 177Lu-Trastuzumab in patients with HER2-positive breast cancer
Phase 2
- Conditions
- Malignant breast cancer.Malignant neoplasm of breast
- Registration Number
- IRCT20210612051548N3
- Lead Sponsor
- Boushehr University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 15
Inclusion Criteria
Age =18 years
Patients with confirmed HER2-positive breast cancer using 68Ga-Trastuzumab PET/CT
Eastern Cooperative Oncology Group Performance Status (ECOG) = 2
Having hematologic parameters as: (i) Absolute neutrophil count = 1000 cells/mm3; (ii) Platelet count = 100,000/mm3; (iii) Hemoglobin = 9 g/dL
Signed informed consent form
Exclusion Criteria
Pregnant woman
Inability to provide written informed consent.
Patients with known sensitivity or contraindication to Herceptin.
The patient had an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
Patients have psychiatric illness/social situations that would interfere with compliance with study requirements
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umbe of treated breast cancer patients. Timepoint: 4-6 weeks after last treatment session. Method of measurement: Image-based response using 68Ga-Trastuzumab PET/CT.
- Secondary Outcome Measures
Name Time Method