The purpose of this study is to assess the efficacy of goserelin plus fulvestrant 500mg comparing with goserelin plus anastrozole as first line endocrine therapy for pre- and perimenopausal HR+ advanced breast cancer.
Premenopausal advanced breast cancer patients who failed tamoxifen treatment are possible good candidates for ovarian ablation/suppression and aromatase inhibitors.Fulvestrant has been studied little in premenopausal women despite of its attractive mechanism of actions. Based on this rationale, we introduced high-dose of fulvestrant with LHRH agonist as a randomized trial comparing with AI plus LHRH agonist. To assess efficacy of goserelin plus fulvestrant 500mg comparing with goserelin plus anastrozole as first line endocrine therapy for pre- and perimenopausal HR+ advanced breast cancer in terms of progression-free survival(PFS)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Fulvestrant 500mg I.M. Once/28days,until progression or unacceptable toxicity develops
goserelin 3.6mg subcutaneously every 28(± 3) days
Anastrozole 1mg P.O. once daily, until progression or unacceptable toxicity develops
307 Hospital
Beijing, Beijing Municipality, China
RECRUITINGthe efficacy of goserelin plus fulvestrant 500mg and the efficacy of goserelin plus anastrozole as first line endocrine therapy for pre- and perimenopausal HR+ advanced breast cancer in terms of progression-free survival(PFS)
Primary endpoint is progression-free survival. Progression-free survival (PFS) is defined as the time elapsed between randomization and tumor progression(by RECIST version 1.1) or death from any cause
Time frame: Progression-free survival (PFS) is defined as the time elapsed between randomization and tumor progression(by RECIST version 1.1) or death from any cause.Participants will be followed for an expected average of 1 year.
the overall response rate(by RECIST version 1.1) of patients treated with goserelin plus fulvestrant 500mg and the overall response rate of patients treated with goserelin plus anastrozole.
to compare overall response rate of patients treated with goserelin plus fulvestrant 500mg with overall response rate of patients treated with goserelin plus anastrozole.
Time frame: Participants will be followed for an expected average of 1 year.
the clinical benefit rate of patients treated with goserelin plus fulvestrant 500mg and clinical benefit rate of patients treated with goserelin plus anastrozole.
Time frame: Participants will be followed for an expected average of 1 year.
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goserelin 3.6mg subcutaneously every 28(± 3) days