Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Adult female patients with advanced breast cancer diagnosed by pathology (aged 18-75, including 18 and 75 years old), not suitable for surgical resection or radiation therapy for the purpose of cure; * Pathological examination confirmed ER and / or PR positive, HER-2 negative (Positive ER expression: immunohistochemistry \>1% tumor cell staining; Positive PR expression: immunohistochemistry \>1% tumor cell staining; HER-2 negative: immunohistochemistry is 0,1+, or FISH/CISH negative when immunohistochemistry is 2+); * 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. * WHO physical status 0-1 points, estimated lifetime at least 3 months; * Imaging examinations within 3 weeks before enrollment were req