Breast Cancer
Conditions
Interventions
Active Comparator:capecitabine
Experimental group:fulvestrant
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically diagnosis of adult female advanced breast cancer (aged 18 - 75 years old), not suitable to accept surgery or radiotherapy for healing; 2. Histologically diagnosis of hormone receptor positive (ER and/or PR+), HER2 negative breast cancer(ER positive: immunohistochemistry (IHC) >1% tumor cell staining; PR positive: immunohistochemistry (IHC) >1% tumor cell staining; HER-2 negative: immunohistochemistry 0, 1+, or 2+ while FISH/CISH negative); 3. Patients have completed 4-8 cycles first-line chemotherapy for metastatic breast cancer without disease progress (CR/PR/SD);Capecitabine single-agent first-line chemotherapy is allowed, but the number of treatment courses is limited to 6 courses; 4. WHO performance status 0-1, Life expectancy > 3 months; 5. Imaging examination within 3 weeks before enrollment are needed (can be check at the local Grade IIIA hospitals), to assess the tumor lesions before maintenance treatment; 6. Treatment-related toxicity at randomization should be relieved to NCI CTCAE (version 4.03) = grade 1 (except alopecia or other toxicities of no risk to patient safety based on the researchers' judgment) 7. Blood tests were basically normal within 1 week before enrollment: a. white blood cells (WBC)=3.0×10^9/L, b. Neutrophil count(ANC)=1.5×10^9/L, c. Platelet count(PLT)=100×10^9/L; 8. Normal liver and kidney function within 1 week before enrollment: Total bilirubin(TBIL) =1.5× upper limit normal(ULN), Alanine aminotransferase and Aspartate aminotransferase(ALT/AST) =2.5×ULN (liver metastasis =5×ULN), Serum creatinine =1.5×ULN or Creatinine clearance(Ccr)=60 ml/min; 9. Signed informed consent prior to any study-specific procedures;
Exclusion criteria
Exclusion criteria: 1. New-onset central nervous system metastases or brain metastases with stable symptom control for less than 4 weeks (asymptomatic patients with stable imaging for more than 4 weeks do not require corticosteroid therapy can be included in the group); 2. Patients with other malignant tumor history within 3 years before randomization, except the healed skin basal cell carcinoma or Squamous cell cancer or orthotopic cervical cancer; 3. previous endocrine therapy for advanced breast cancer; 4. pregnancy or lactation; 5. Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the study protocol, eg, uncontrollable cardiac disease or Hypertension, active or uncontrollable infection, active hepatitis B virus infection; 6. Unable to tolerate capecitabine toxicity at First-line treatment. 7. Adjuvant endocrine therapy for patients with recurrent and metastatic disease within 2 years (including 2 years).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objective response rate;clinical benifit rate;the rate of adverse events;Quality of life 1(QOL1);Quality of life 2(QOL2); | — |
Countries
China
Contacts
Public ContactHerui Yao
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcome results
None listed