Overview
This phase III trial aims to compare the progression free survival (PFS) and safety of fulvestrant or capecitabine as maintenance therapy after first-line combined chemotherapy in hormone receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer.
Description
Metastatic breast cancer (MBC) is incurable. Although first-line endocrine therapy is preferred to hormone receptor positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) MBC, combination chemotherapy should be reserved as the initial treatment for patients with rapid clinical progression, life-threatening visceral metastases, and need for rapidly symptom control. Either prolonged chemotherapy or endocrine therapy may be used as maintenance after disease control. However, which maintenance strategy is superior in terms of delaying disease progression as well as maintaining quality of life (QOL) remains uncertain. This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line combined chemotherapy in HR+/HER2- MBC.
Eligibility
Inclusion Criteria:
- Adult female patients with advanced breast cancer diagnosed by pathology (aged 18-70, including 18 and 70 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)
- WHO physical status 0-1 points, estimated lifetime at least 3 months;
- Imaging examinations within 3 weeks before enrollment were required for assessing tumor lesions before maintenance treatment (Examination results from local Tertiary A hospital are available);
- Previous treatment-related toxicity should be relieved to Grade 1 according to NCI CTCAE (version 4.03) before randomization (Except for hair loss and other toxicities that are not at risk to the patient's safety based on the investigator's judgment);
- The routine blood test was normal within 1 week before enrollment: WBC 3.010^9L, b. ANC 1.510^9L, c. PLT 10010^9L;
- 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. TBIL1.5 Upper Limit of Normal (ULN)b. ALT/AST2.5ULNLiver metastasis patients 5xULN c. Serum Cr 1.5ULN, or Ccr 60 ml/min;
- Informed consent form signed before enrollment.
Exclusion Criteria:
Cannot be grouped if any of the following is true:
- Central nervous system metastasis (including brain parenchyma, pia mater, and meningeal metastasis)
- Diagnosis of any other malignant tumor within 3 years before randomization, except for adequately treated basal cells or squamous cell skin cancer or cervical cancer in situ;
- Endocrine therapy for advanced disease;
- Pregnant or breast-feeding patients;
- Patients with accompanying disease or situation that may interfere with the study, or any serious medical problems that may affect the safety of the subject (for example, uncontrolled heart disease or high blood pressure, active or uncontrolled infection, active hepatitis B virus infection);
- Patients who were unable to tolerate capecitabine toxicity were first identified in first-line treatment;
- Patients with recurrent metastatic disease within 2 years of adjuvant endocrine therapy (including 2 years);
- Patients with first-line capecitabine monotherapy.