Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-31 @ 10:42 AM
Study NCT ID:
NCT00503906
Status:
COMPLETED
Last Update Posted:
2017-05-12
First Post:
2007-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Abraxane, Avastin, and Gemcitabine as First-Line Therapy for Patients With Metastatic Breast Cancer
Sponsor:
University of Miami
Organization:
Study Overview
Official Title:
A Phase II Study of Abraxane, Avastin and Gemcitabine for First Line Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-05
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:
None
Brief Summary:
The investigators hypothesize that the combination of Gemzar®, Abraxane® and Avastin will increase the progression-free survival (PFS) in patients with first line metastatic breast cancer and in patients who received neoadjuvant and/or adjuvant chemotherapy present with definable metastatic disease, 6 or more months after primary treatment.
Detailed Description:
This is a phase 2, single arm study. Participants will be treated with combination Gemzar, Abraxane and Avastin therapy until disease progression. Each treatment cycle is 28 days.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SCCC-2006081 | OTHER | University of Miami Sylvester Comprehensive Cancer Center | View |