Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-03-13 @ 9:53 PM
Study NCT ID:
NCT02483767
Status:
COMPLETED
Last Update Posted:
2017-10-17
First Post:
2015-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
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:
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 (1:1) 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 vs.36-44years), hormone receptor status (HR+ or ER+ vs.HR- and ER-), chemotherapy regimen(3-4 cycles vs.6-8 cycles, and cyclophosphamide-based vs.noncyclophosphamide).The 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:
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?: