Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 or older 4. Diagnosis of stage I-IIIB breast cancer 5. Received neoadjuvant chemotherapy (minimum of 3 cycles) and surgical resection (lumpectomy and/or mastectomy) 6. Discovered to have residual disease at least ypT1aNx or ypTxN1mic at surgical resection 7. Candidate for adjuvant chemoradiation as part of standard clinical care 8. Planned initiation of radiation within 12 weeks of their final oncologic surgery 9. ECOG performance status ≤2 10. Adequate cardiac function, with LVEF greater or equal to 45% (only for patients who will receive TDM-1 therapy) 11. Adequate organ function per the following criteria within 21 days before the start of treatment. If a laboratory value required for study eligibility does not meet the below requirements, the value may be retested. * Absolute ne