Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia
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 groupsSponsors and collaborators
Source ClinicalTrials.gov