Definitive Radiation Therapy for Inoperable Breast Cancer
Multi-institutional Prospective Pilot Study of Definitive Breast Radiation Therapy for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
Alexander Stessin
30 participants
Dec 8, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to find out if adding radiation therapy to routine medications for breast cancer helps in reducing and preventing the cancer from getting worse. Patients with a locally advanced breast cancer who cannot, or do not want to, undergo surgery are eligible to participate. Participation in this study does not prevent you from undergoing surgery in the future.
Eligibility
Inclusion Criteria5
- Biopsy proven invasive carcinoma of the breast, either lobular, ductal and/or no special type
- T1-T4, N0-2, M0-1 invasive breast carcinoma by radiological or clinical criteria
- Cancer is deemed unresectable, or the patient is a poor surgical candidate as determined following evaluation by a surgeon, or patient declines surgery.
- Life expectancy \> 6 months
- Negative pregnancy test at the time of start of treatment in any female of reproductive age
Exclusion Criteria3
- Concurrent systemic therapy (except for endocrine therapy, HER2-targeted therapy, or immunotherapy which are permitted)
- Prior radiation to ipsilateral breast or regional nodes
- Inability to receive study treatment planning and treatment secondary to body habitus
Interventions
Radiation with 26Gy to the whole breast and 40Gy simultaneous integrated boost to gross disease in the breast, in five fractions
Radiation with 26Gy to the whole breast and regional nodes with a 40Gy simultaneous integrated boost to gross disease in breast and ipsilateral axillary nodal areas, in five fractions
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07122713