A Study of Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
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.
• 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
• Received neoadjuvant chemotherapy (minimum of 3 cycles) and surgical resection (lumpectomy and/or mastectomy)
• Discovered to have residual disease at least ypT1aNx or ypTxN1mic at surgical resection
• Candidate for adjuvant chemoradiation as part of standard clinical care
• Planned initiation of radiation within 12 weeks of their final oncologic surgery
• ECOG performance status ≤2
⁃ Adequate cardiac function, with LVEF greater or equal to 45% (only for patients who will receive TDM-1 therapy)
⁃ 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 neutrophil count ≥1.5 k/uL
‣ Platelets ≥100 k/uL
‣ Hemoglobin ≥ 10 g/dL
‣ Serum Creatinine ≤ 1.5 x ULN
‣ Bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 4x ULN is allowed).
‣ AST and ALT ≤ 2.5 x ULN
‣ Alkaline phosphatase ≤ 2.5 x ULN
⁃ For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 6 months after the end of chemoradiation administration or until advised by their medical oncologist
⁃ Agreement to adhere to Lifestyle Considerations throughout study duration
⁃ Subjects taking warfarin and plan to receive capecitabine will need their anticoagulant management assessed before starting treatment.