Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504699
Status:
TERMINATED
Last Update Posted:
2018-03-29
First Post:
2007-07-18
Brief Title:
Safety of Ovarian Stimulation With Letrozole and Gonadotropins in Breast Cancer Patients
Sponsor:
New York Medical College
Organization:
New York Medical College
Study Overview
Official Title:
Safety of Ovarian Stimulation With Letrozole and Gonadotropins in Breast Cancer Patients Undergoing Embryo or Oocyte Cryopreservation A Prospective Controlled Follow up Study
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The PI left the Institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast cancer patients are commonly treated with drugs that eggs present in the ovary and may reduce their chance for getting pregnant Their fertility can be preserved by stimulating their ovaries collecting multiple eggs fertilize them in the lab and freeze them Ovarian stimulation increase their estrogen levels in bloodthis may stimulate their cancer and increase chance for recurrence If a medicine that prevent estrogen rise is used letrozole this may increase the safety of stimulation In this study we compared ovarian stimulation in breast cancer patients using letrozole with those who did not undergo stimulation and showed that there is no increase risk for recurrence after a median follow up of 2 years
Detailed Description:
215 women with breast cancer were evaluated for fertility preservation before chemotherapy Of those 79 elected to undergo controlled ovarian stimulation COH with letrozole and gonadotropins for embryo or oocyte cryopreservation The 136 patients who declined served as controlsThere were no significant differences between the study and control groups regarding age at diagnosis breast cancer prognostic parameters tumor size grade number of positive lymph nodes estrogen receptor status her2-neu overexpression and vascular space invasion and chemotherapy regimens There was no difference between the two groups in the projected 10 year relapse breast cancer specific mortality or overall mortality There were 3 recurrences or contralateral breast cancers 2 distant 1 locoregional in the letrozole group and 11 in the control group 9 distant 1 locoregional 1 contralateral breast
Comparison breast cancer patients that underwent ovarian stimulation with letrozolegonadotropins and those who declined ovarian stimulation
Comparison breast cancer patients that underwent ovarian stimulation with letrozolegonadotropins and those who declined ovarian stimulation
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