This is an open-label, single arm, phase II trial to evaluate the efficacy and safety of 500mg Fulvestrant (Faslodex®) in ESR1 mutated postmenopausal women with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer after previous aromatase inhibitor therapy. Fifty patients will be enrolled and treated with 500 mg Fulvestrant until disease progression or study closed. Treatment will continue until disease progression, unless any of the criteria for treatment discontinuation are met first. If a patient progresses during the treatment period, the patient must be withdrawn from the treatment and further treatment will be at the investigator's discretion.
Name: Fulvestrant
Description: Fulvestrant 500 mg given as two 5 ml intramuscular inections, one in each buttoc, on days 1, 15, 2 and every 2 ( ) days thereafter.Type: DrugESR1 mutated
Description: The study will be closed at all the patients progressed or 12 months after the last patient has been recruited depends on which one met first. From date of the first recruitment until the date of all the patients progressed or 12 months after the last patient has been recruited, whichever came first, assessed up to 10 years.
Measure: Tumour assessment Time: An average of 5 years, up to 10 years.Single Group Assignment
There are 5 SNPs
The blood sample is clarified to be ESR1 mutated, The mutation should be: Y537C, Y537N, Y537S, S463P and D538G. --- Y537C --- --- Y537N --- --- Y537S --- --- S463P --- --- D538G ---
The blood sample is clarified to be ESR1 mutated, The mutation should be: Y537C, Y537N, Y537S, S463P and D538G. --- Y537C --- --- Y537N --- --- Y537S --- --- S463P ---
The blood sample is clarified to be ESR1 mutated, The mutation should be: Y537C, Y537N, Y537S, S463P and D538G. --- Y537C ---
The blood sample is clarified to be ESR1 mutated, The mutation should be: Y537C, Y537N, Y537S, S463P and D538G. --- Y537C --- --- Y537N ---
The blood sample is clarified to be ESR1 mutated, The mutation should be: Y537C, Y537N, Y537S, S463P and D538G. --- Y537C --- --- Y537N --- --- Y537S ---