Ignite Creation Date:
2024-05-06 @ 2:16 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT02000193
Status:
UNKNOWN
Last Update Posted:
2018-07-10
First Post:
2013-11-13
Brief Title:
Maintenance Hormone Therapy for Postmenopausal HR Positive Advanced Breast Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Maintenance Hormone Therapy With Fulvestrant After First-Line Chemotherapy for Postmenopausal Hormone-receptor-positive HR Positive Advanced Breast Cancer A Multicenter Prospective Phase II Study
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
ACTIVE_NOT_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:
FANCY
Brief Summary:
This is a prospective single arm phase II study to evaluate the efficacy and safety of fulvestrant as a maintenance hormone therapy after first-line chemotherapy for postmenopausal HR positive advanced breast cancer
Detailed Description:
This is a prospective single arm phase II study to evaluate the efficacy and safety of fulvestrant as a maintenance hormone therapy after first-line chemotherapy for postmenopausal HR positive advanced breast cancer
Approximately 58 women who have stable disease or responded to first line chemotherapy with at least 4 and less than 8 weeks of treatment for metastatic breast cancer will be enrolled to this study and receive fulvestrant 500mg as a maintenance therapy The treatment will continue until the objective disease progression or intolerable AE
Efficacy will be determined based on tumor assessments performed by each investigator according to RECIST Response Evaluation Criteria in Solid Tumors 11 Safety will be monitored based on the frequency and severity of adverse events AEs as assessed by Common Terminology Criteria CTC grade version 40
Tumor assessments will be assessed by computed tomography CT or magnetic resonance imaging MRI every 12 weeks for all patients until documented evidence of objective disease progression
Reporting of SAEs serious adverse events to regulatory authorities will be done by the investigator in accordance with local regulations
Approximately 58 women who have stable disease or responded to first line chemotherapy with at least 4 and less than 8 weeks of treatment for metastatic breast cancer will be enrolled to this study and receive fulvestrant 500mg as a maintenance therapy The treatment will continue until the objective disease progression or intolerable AE
Efficacy will be determined based on tumor assessments performed by each investigator according to RECIST Response Evaluation Criteria in Solid Tumors 11 Safety will be monitored based on the frequency and severity of adverse events AEs as assessed by Common Terminology Criteria CTC grade version 40
Tumor assessments will be assessed by computed tomography CT or magnetic resonance imaging MRI every 12 weeks for all patients until documented evidence of objective disease progression
Reporting of SAEs serious adverse events to regulatory authorities will be done by the investigator in accordance with local regulations
Study Oversight
Has Oversight DMC:
None
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?:
None