Ignite Creation Date:
2024-05-05 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00726661
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2008-07-30
Brief Title:
An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer VIRGO
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-06
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:
VIRGO
Brief Summary:
This is a multicenter prospective observational cohort study OCS designed to follow patients with locally recurrent or metastatic breast cancer in the United States Two cohorts will be included
Patients with human epidermal growth factor receptor 2-negative HER2-negative disease receiving their first cytotoxic chemotherapy andor targeted therapy approximately 825 patients
Patients with hormone receptor-positive HR-positive disease receiving their first hormonal therapy for advanced disease approximately 425 patients
Patients who have received any chemotherapy for advanced disease more than 8 weeks prior to enrollment to this OCS will not be eligible A total of approximately 1250 patients will be enrolled Approximately 150 study sites will be activated in order to achieve complete enrollment by December 2010
Patients with human epidermal growth factor receptor 2-negative HER2-negative disease receiving their first cytotoxic chemotherapy andor targeted therapy approximately 825 patients
Patients with hormone receptor-positive HR-positive disease receiving their first hormonal therapy for advanced disease approximately 425 patients
Patients who have received any chemotherapy for advanced disease more than 8 weeks prior to enrollment to this OCS will not be eligible A total of approximately 1250 patients will be enrolled Approximately 150 study sites will be activated in order to achieve complete enrollment by December 2010
Detailed Description:
None
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