OncoMatch/Clinical Trials/NCT04768426
Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer
Is NCT04768426 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Capecitabine for triple negative breast cancer.
Treatment: Capecitabine — The purpose of the study is to evaluate the use of a circulating tumor DNA (ctDNA) assay, ie, a "liquid biopsy," as a tool to identify triple-negative breast cancer (TNBC) patients who will or will not experience benefit from treatment with capecitabine. Participants will be monitored for changes in ctDNA in the blood over time received during capecitabine treatment. Results of ctDNA analysis will be correlated to genetic characteristics of individual tumors. This may inform future clinical trials in which patients could receive a different treatment than capecitabine to reduce their risk of breast cancer relapse.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 low expression (<10%)
Estrogen receptors (ER) ... status <10%
Required: PR (PGR) low expression (<10%)
Progesterone receptors (PR) status <10%
Disease stage
Required: Stage I, II, III
Excluded: Stage IV
Anatomic stage I - III triple-negative breast cancer at diagnosis; No evidence of metastatic disease.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: neoadjuvant chemotherapy — neoadjuvant
Residual disease following at least 4 cycles of neoadjuvant chemotherapy
Must have received: surgical resection — definitive
Has not had definitive surgical resection [excluded]
Cannot have received: investigational agent
Exception: allowed if >4 weeks prior to study initiation
Investigational agents within 4 weeks of study initiation
Lab requirements
Blood counts
ANC ≥ 1,500 cells/μL; Platelets ≥ 100,000 cells/μL
Kidney function
Serum creatinine ≤ 1.5 x ULN; or calculated creatinine clearance > 50 mL/min using Cockcroft Gault formula
Liver function
Bilirubin ≤ 1.5 x ULN (≤ 5 x ULN if Gilbert's syndrome); AST and ALT ≤ 2.5 x ULN
Adequate hematologic function: Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3) Adequate hepatic function: Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN. Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN Adequate renal function: Serum creatinine ≤ 1.5 x ULN; or calculated creatinine clearance > 50 mL/min using the Cockcroft Gault formula.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford University · Stanford, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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