OncoMatch/Clinical Trials/NCT04263298
Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer
Is NCT04263298 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Fulvestrant and Capecitabine Oral Product for metastatic breast cancer.
Treatment: Fulvestrant · Capecitabine Oral Product — This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in hormone receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 positive expression (immunohistochemistry >1% tumor cell staining)
Positive ER expression: immunohistochemistry >1% tumor cell staining
Required: PR (PGR) positive expression (immunohistochemistry >1% tumor cell staining)
Positive PR expression: immunohistochemistry >1% tumor cell staining
Required: HER2 (ERBB2) negative (immunohistochemistry 0, 1+, or FISH/CISH negative when immunohistochemistry is 2+)
HER-2 negative: immunohistochemistry is 0,1+, or FISH/CISH negative when immunohistochemistry is 2+
Disease stage
Metastatic disease required
not suitable for surgical resection or radiation therapy for the purpose of cure
Performance status
WHO 0–1
Prior therapy
Must have received: chemotherapy (capecitabine) — first-line
Patients with advanced breast cancer who have no disease progression after a 4-8-course first-line chemotherapy regimen (the effect is evaluated as complete response/ partial response/ stable disease). Capecitabine monotherapy as first-line chemotherapy is allowed and the courses of treatment should be limited to 6.
Cannot have received: endocrine therapy
Endocrine therapy for advanced disease
Cannot have received: endocrine therapy
Patients with recurrent metastatic disease within 2 years of adjuvant endocrine therapy (including 2 years)
Lab requirements
Blood counts
WBC ≥3.0×10^9/L, ANC ≥1.5×10^9/L, PLT ≥100×10^9/L
Kidney function
Serum Cr ≤1.5×ULN, or Ccr ≥60 ml/min
Liver function
TBIL≤1.5× ULN; ALT/AST≤2.5×ULN (liver metastasis patients ≤5xULN)
The routine blood test was normal within 1 week before enrollment: WBC ≥3.0×10^9／L, b. ANC ≥1.5×10^9／L, c. PLT ≥100×10^9／L; The liver and kidney function test was normal within 1 week before enrollment (Take the normal value of the laboratory of each research center as the standard): a. TBIL≤1.5× Upper Limit of Normal (ULN)b. ALT/AST≤2.5×ULN（Liver metastasis patients ≤5xULN） c. Serum Cr ≤1.5×ULN, or Ccr ≥60 ml/min;
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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