OncoMatch/Clinical Trials/NCT05212454
Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks
Is NCT05212454 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Capecitabine for breast cancer.
Treatment: Capecitabine — According to the latest data from the World Health Organization's International Agency for Research on Cancer (IARC) for 2020, breast cancer has been the most prevalent cancer with 2.26 million new cases. Among Chinese breast cancer patients, approximately 60% are hormone receptor (HR) positive, and 80% have early-stage breast cancer. For HR-positive, human epidermal growth factor receptor-2 (HER2) negative breast cancer patients, the first peak of recurrence is about 2-3 years after surgery, especially for patients with high-risk clinical and/or pathological features. Therefore, adjuvant therapy is essential to reduce recurrence during this period. Capecitabine is an anti-metabolite fluoropyrimidine deoxynucleoside carbamate that can be converted to fluorouracil (5-Fu) in vivo. Studies have shown that patients with HR-positive HER2-negative breast cancer with high-risk factors may benefit from postoperative adjuvant capecitabine therapy as well as patients with triple-negative breast cancer. Therefore, we assumed that additional capecitabine may reduce the reccurence of breast cancer in patients with high-risk factors. This trial is an open, single-arm clinical trial designed to investigate the effect of additional adjuvant capecitabine therapy on recurrence and survival in HR-positive HER2-negative breast cancer patients with high-risk factors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (positive cells >1%)
ER and/or PR positive (defined as positive cells >1%)
Required: PR (PGR) overexpression (positive cells >1%)
ER and/or PR positive (defined as positive cells >1%)
Required: HER2 (ERBB2) negative (IHC 2+ or less and FISH negative)
HER2 negative (defined as HER2 immunohistochemistry 2+ or less and FISH negative)
Disease stage
Grade: 3 (histologic)
histologic grade 3
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery — curative
Completed radical breast cancer surgery
Lab requirements
Blood counts
WBC ≥ 4.0×10^9/L, ANC ≥ 1.5×10^9/L, PLT ≥ 100×10^9/L; Hb ≥ 90g/L
Kidney function
creatinine ≤ 1.5 times the upper limit of normal value
Liver function
AST (sGOT), ALT (sGPT) ≤ 1.5 times the normal value upper limit; total bilirubin ≤ 1.5 times the upper limit of normal value
Cardiac function
No serious impairment of heart function
Hematological examination before treatment should meet: white blood cell count (WBC) ≥ 4.0×10^9/L, neutrophil count (ANC) ≥ 1.5×10^9/L, platelet count (PLT) ≥ 100×10^9/L; hemoglobin (Hb) ≥ 90g/L; AST (sGOT), ALT (sGPT) ≤ 1.5 times the normal value upper limit, creatinine ≤ 1.5 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value. No serious impairment of heart, liver, kidney and other important organ functions.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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