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 (Jun 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
Treatments studied
Chemotherapy
Endocrine / hormonal
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
Demographics
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.
Frequently asked questions
Is NCT04263298 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior endocrine therapy, endocrine therapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 positive expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR positive expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
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 qualify