Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417885
Status:
TERMINATED
Last Update Posted:
2010-09-21
First Post:
2007-01-02
Brief Title:
A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER Estrogen Receptor andor PgR Progesterone Receptor Breast Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Phase 12 Open-Label Trial Of Sutent Sunitinib Malate And AromasinExemestane In The First-Line Treatment Of Hormone Receptor-Positive Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See Detailed Description for Termination Reason
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent unresectable breast cancer
Detailed Description:
The trial was terminated prematurely on August 28 2008 due to the inability to recruit the planned number of subjects in order to provide meaningful efficacy data There were no safety concerns regarding the study in the decision to terminate the trial
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