OncoMatch/Clinical Trials/NCT05288777
Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
Is NCT05288777 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including T-DM1 and Capecitabine for breast cancer.
Treatment: T-DM1 · Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Disease stage
Required: Stage I, II, IIIA, IIIB
Diagnosis of stage I-IIIB breast cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: neoadjuvant chemotherapy — neoadjuvant
Received neoadjuvant chemotherapy (minimum of 3 cycles)
Must have received: surgical resection
surgical resection (lumpectomy and/or mastectomy)
Cannot have received: mastectomy with expander placement or immediate reconstruction
Had a mastectomy with expander placement or immediate reconstructions
Cannot have received: anthracycline (doxorubicin)
Exception: cumulative dose ≤ 264 mg/m2 (240 mg/m2 plus a 10% threshold)
Anthracycline exposure exceeding a cumulative doxorubicin dose of 264 mg/m2 (240 mg/m2 plus a 10% threshold)
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5 k/uL; Platelets ≥100 k/uL; Hemoglobin ≥ 10 g/dL
Kidney function
Serum Creatinine ≤ 1.5 x ULN
Liver function
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
Cardiac function
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 Adequate cardiac function, with LVEF greater or equal to 45% (only for patients who will receive TDM-1 therapy)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Virginia · Charlottesville, Virginia
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