OncoMatch/Clinical Trials/NCT05288777
Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
Is NCT05288777 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05288777 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior mastectomy with expander placement or immediate reconstruction, anthracycline disqualifies patients from enrollment.
What disease stage is eligible?
Stage I or II or IIIA or IIIB is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages