Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217672
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2005-09-20
Brief Title:
Docetaxel With Bevacizumab as First-Line Therapy in Treating Women With Stage IV Breast Cancer
Sponsor:
Translational Oncology Research International
Organization:
Translational Oncology Research International
Study Overview
Official Title:
A Randomized Phase II Trial of Docetaxel With or Without Bevacizumab as First-Line Therapy for Human Epidermal Growth Factor Receptor 2 HER2-Negative Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-02
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:
RATIONALE Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor It is not yet known whether giving docetaxel together with bevacizumab is more effective than docetaxel alone in treating breast cancer
PURPOSE This randomized phase II trial is studying how well giving docetaxel together with bevacizumab works compared to docetaxel alone as first-line therapy in treating women with stage IV breast cancer
PURPOSE This randomized phase II trial is studying how well giving docetaxel together with bevacizumab works compared to docetaxel alone as first-line therapy in treating women with stage IV breast cancer
Detailed Description:
This trial began as a 2-arm study with a docetaxel-alone arm When bevacizumab became widely available it was converted to a 1-arm open-label trial of docetaxelbevacizumab Patients enrolled in the docetaxel-alone arm were permitted to cross over to docetaxelbevacizumab Patients received bevacizumab 15 mgkg and docetaxel 75 mgm2 intravenously IV every 3 weeks until disease progression unacceptable toxicity or consent withdrawal
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TORI-B-01 | OTHER | UCLA | None |
| UCLA-0501049-01 | OTHER | None | None |