Ignite Creation Date:
2024-05-06 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05140655
Status:
UNKNOWN
Last Update Posted:
2021-12-01
First Post:
2021-11-11
Brief Title:
Effectiveness and Safety of Fulvestrant in Postmenopausal Women With Advanced Breast Cancer HR HER2-
Sponsor:
Dr Reddys Laboratories SAS
Organization:
Dr Reddys Laboratories SAS
Study Overview
Official Title:
Real-world Effectiveness and Safety of a Generic Fulvestrant Alone or in Combination With Cyclin Inhibitors in Postmenopausal Women With Advanced Breast Cancer HR HER2- in Two Colombian Referral Centers
Status:
UNKNOWN
Status Verified Date:
2021-11
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:
None
Brief Summary:
A phase IV single arm study will be performed in postmenopausal women with locally advanced or metastatic breast cancer All patients included will receive fulvestrant from Dr Reddys Laboratories in accordance with local practice and the regulatory authorization of the drug in Colombia This study will be carried out for 1 year and approximately 40 patients will be included in 2 research centers selected for its conduct
Patients who meet the inclusion criteria and who do not have to be discarded from entering the study due to meeting any of the exclusion criteria will be evaluated to determine the effectiveness and tolerability of the administration of Dr Reddys fulvestrant at a dose of 500 mg month plus an additional indicated dose 14 days after the initial dose for 12 months of follow-up or until disease progression or the appearance of unacceptable toxicity The assessment of tolerability will be carried out based on the collection of data related to adverse events from the first dose administered
Patients who meet the inclusion criteria and who do not have to be discarded from entering the study due to meeting any of the exclusion criteria will be evaluated to determine the effectiveness and tolerability of the administration of Dr Reddys fulvestrant at a dose of 500 mg month plus an additional indicated dose 14 days after the initial dose for 12 months of follow-up or until disease progression or the appearance of unacceptable toxicity The assessment of tolerability will be carried out based on the collection of data related to adverse events from the first dose administered
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None