Status:
UNKNOWN
Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients
Lead Sponsor:
Campus Bio-Medico University
Conditions:
Stage IV Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a dose escalation study involving stage IV breast cancer patients not progressing after 6 months of first line systemic treatment. Potential advantages of stereotactic body radiotherapy (SBRT)...
Eligibility Criteria
Inclusion
- Age: 18 years or older
- Histologically confirmed diagnosis of invasive breast carcinoma (biological immunohistochemical profile: luminal and/or human epidermal growth factor receptor 2 positive)
- Distant metastatic disease not progressing after 6 months of systemic therapy
- Zubrod Performance status of 0-1
- Unifocal tumour \< 5 cm tumor size
- Tumor CT or 18-labeled fluorodeoxyglucose positron emission tomography (5FDG-PET) detectable
- No surgery being recommended at time of enrollment.
Exclusion
- prior radiotherapy
- active systemic lupus erythematosus, or any history of scleroderma, dermatomyositis with active rash
- Women who are pregnant or lactating.
- Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol
Key Trial Info
Start Date :
July 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05229575
Start Date
July 10 2020
End Date
April 10 2023
Last Update
February 8 2022
Active Locations (1)
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1
Università Campus Biomedico
Roma, Italy