OncoMatch/Clinical Trials/NCT03561740
A Study of the Addition of Metronomic Capecitabine to Standard Adjuvant Therapy in High Risk HER2+ BC paTients
Is NCT03561740 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies capecitabine for breast cancer.
Treatment: capecitabine — Breast cancer is the most common malignant tumor in women. Recurrent or metastatic breast cancer is incurable. High risk patients usually have the following characteristics, such as, non-pCR after neoadjuvant therapy, lymph nodes positive, \>2cm tumor size, HER2 overexpression, etc. Intensive targeted or chemo therapy could improve prognosis. Previous studies have shown the efficacy and feasibility of intensive treatment of capecitabine in non-pCR breast cancer patients. Given the metronomic capecitabine therapy is well tolerated, we designed this study to compare the efficacy and safety of adding metronomic capecitabine to standard adjuvant therapy for high risk HER2+ breast cancer patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression
HER2-positive
Required: ESR1 known hormone receptor status
Known hormone receptor status
Required: PR (PGR) known hormone receptor status
Known hormone receptor status
Disease stage
Required: Stage EARLY STAGE
Excluded: Stage IV
Early stage operable HER2-positive primary breast cancer; Stage IV (metastatic) breast cancer [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy — neoadjuvant
Systemic therapy must consist of at least 6 cycles of chemotherapy, with a total duration at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based chemotherapy. Patients may have received an anthracycline as part of preoperative therapy in addition to taxane chemotherapy. Patients receiving dose-dense chemotherapy regimens are eligible, provided at least 8 weeks of taxane-based therapy and at least 8 weeks of trastuzumab have been given.
Must have received: HER2-targeted therapy (trastuzumab) — neoadjuvant
including at least 9 weeks of trastuzumab
Must have received: taxane — neoadjuvant
at least 9 weeks of taxane-based chemotherapy
Cannot have received: anti-cancer investigational drug
Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment
Cannot have received: anthracycline (doxorubicin)
Exception: cumulative dose >240 mg/m2
History of exposure to the following cumulative doses of anthracyclines: Doxorubicin >240 mg/m2
Cannot have received: anthracycline (epirubicin, liposomal doxorubicin-hydrochloride (Myocet®))
Exception: cumulative dose >480 mg/m2
Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) >480 mg/m2
Cannot have received: anthracycline
Exception: exposure equivalent to doxorubicin >240 mg/m2
For other anthracyclines, exposure equivalent to doxorubicin >240 mg/m2
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1200 cells/mm3; Platelet count ≥ 100000 cells/mm3; Hemoglobin ≥ 9.0 g/dL; patients may receive red blood cell transfusions to obtain this level
Kidney function
Serum creatinine 1.5 upper limit of normal (ULN)
Liver function
Serum AST and ALT ≤ 1.5 ULN; Serum total bilirubin (TBILI) ≤ 1.0 ULN (within normal limits), except for patients with Gilbert's syndrome, for whom direct bilirubin should be within the normal range; Serum alkaline phosphatase (ALK) ≤ 1.5 ULN; INR and aPTT ≤ 1.5 ULN
Cardiac function
Screening LVEF ≥ 50% on ECHO or MUGA after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be ≥ 55% after completion of neoadjuvant chemotherapy.
Adequate organ function during screening, defined as: ... (see above for full details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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