Ignite Creation Date:
2024-05-06 @ 7:11 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02483767
Status:
COMPLETED
Last Update Posted:
2017-10-17
First Post:
2015-06-09
Brief Title:
Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
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:
POF
Brief Summary:
The study is a prospective randomized control clinical trial which is sponsored by the researchers The purpose of this study is to determine the effectiveness of Gonadotropin-Releasing hormone agonist on ovarian function for premenopausal breast cancer patients during chemotherapy The premenopausal breast cancer patients will be randomly 11 enrolled to receive standard chemotherapy with the GnRH agonist goserelin goserelin group or standard chemotherapy without goserelin chemotherapy alone group All patients are stratified according to age 35years vs36-44years hormone receptor status HR or ER vsHR- and ER- chemotherapy regimen3-4 cycles vs6-8 cycles and cyclophosphamide-based vsnoncyclophosphamideThe follow-up time will be at least 2years The ovarian failure follicle-stimulating hormone estradiol and anti-Mullerian hormone pregnancy outcomes and disease-free and overall survival will be compared between two groups to evaluate the effectiveness of protect against ovarian failure
Detailed Description:
None
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