Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or female, aged 18 or older

Diagnosis of stage I-IIIB breast cancer

Disqualifiers

Had a mastectomy with expander placement or immediate reconstructions

Diagnosed with systemic lupus

Diagnosed with scleroderma

Diagnosed with a genetic mutation associated with increased sensitivity to radiation (e.g. ataxia-telangectasias (AT)). AT heterozygotes without known radiation sensitivity may be included.

Trial design

Treatments tested in this trial

  • T-DM1
  • Capecitabine
  • External Beam Radiation Therapy 0
  • External Beam Radiation Therapy 1

Treatment groups

45 Participants
are divided into 4 treatment groups

Locations

1
University of Virginia22903, CharlottesvilleVirginia, United States

Sponsors and collaborators

University of Virginia

Lead sponsor

Source ClinicalTrials.gov