Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT00776659
Status:
TERMINATED
Last Update Posted:
2013-11-19
First Post:
2008-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India.
* Efficacy of the treatment with Aromasin®
* Safety of the treatment with Aromasin®
* Efficacy of the treatment with Aromasin®
* Safety of the treatment with Aromasin®
Detailed Description:
NA The study was prematurely discontinued due to slow enrollment and keeping in mind the observational nature of the study. The decision to terminate had been taken on 16th June 2012 and the LSLV occured on 14th September, 2012. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
Study Oversight
Has Oversight DMC:
False
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?: