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RECRUITING
NCT05288777
PHASE2/PHASE3

Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer

Sponsor: University of Virginia

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

Capecitabine

Dosed at 825 mg/m2 +/- 150mg twice per day for a total duration of 6 months

RADIATION

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.

RADIATION

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