Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-03-12 @ 1:05 AM
Study NCT ID:
NCT02072512
Status:
UNKNOWN
Last Update Posted:
2014-02-26
First Post:
2014-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Goserelin Plus Fulvestrant Comparing With Goserelin Plus Anastrozole for Advanced Breast Cancer
Sponsor:
Hospital Affiliated to Military Medical Science, Beijing
Organization:
Study Overview
Official Title:
The Study of Goserelin Plus Fulvestrant Comparing With Goserelin Plus Anastrozole for Advanced Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2014-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROOF
Brief Summary:
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.
Detailed Description:
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)
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: