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Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
Sponsor: University of Virginia
Summary
The goal of this study is to evaluate the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who had received neoadjuvant chemotherapy before their lumpectomy and/or mastectomy and were found to have residual disease. As well as examine the effects of this treatment combination on the immune system.
Official title: A Study of Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2022-07-11
Completion Date
2029-12
Last Updated
2025-04-18
Healthy Volunteers
No
Interventions
T-DM1
Dosed at 3.6 mg/kg of body weight every 3 weeks for Her2/neu+ patients for a total duration of 14 cycles.
Capecitabine
Dosed at 825 mg/m2 +/- 150mg twice per day for a total duration of 6 months
External Beam Radiation Therapy 0
Dose of 40 Gy in 15 fractions to the whole breast or chest wall followed by consideration of a 10 Gy in 4 fraction boost to the lumpectomy cavity for a total duration of 15-19 days. Internal mammary nodal, dissected axilla coverage, and boost will be at the radiation oncologist's discretion.
External Beam Radiation Therapy 1
Dose of 40 Gy in 15 fractions to either the breast or chest wall along with comprehensive nodal radiation followed by consideration of a 10 Gy in 4 fraction boost for a total duration of 15-19 days. Internal mammary nodal, dissected axilla coverage, and boost will be at the radiation oncologist's discretion.
Locations (1)
University of Virginia
Charlottesville, Virginia, United States