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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

July 11, 2022

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2029

Conditions
Breast CancerBreast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage III
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.

Trial Locations (1)

22903

RECRUITING

University of Virginia, Charlottesville

All Listed Sponsors
lead

University of Virginia

OTHER