Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT01156961
Status:
WITHDRAWN
Last Update Posted:
2016-11-02
First Post:
2010-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of The Safety Profile of First-line Avastin (Bevacizumab) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Her2-negative Breast Cancer (AVATAX)
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
Post Registration Observational Program for Patients With Locally Recurrent or Metastatic Breast Cancer Who Receive Bevacizumab (Avastin) in Combination With Paclitaxel for the First-line Treatment
Status:
WITHDRAWN
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Absence of patient's recruitment in the study due to administrative reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This single arm, open label study will assess the safety profile of Avastin (bevacizumab) in combination with paclitaxel as first-line treatment in patients with locally recurrent or metastatic Her2-negative breast cancer. Patients will receive Avastin, either 10 mg/kg intravenously (iv) every 2 weeks or 15 mg/kg iv every 3 weeks. Correspondingly, paclitaxel will be administered at a dose of 90 mg/m2 o days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 on day 1 of every 21-day cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: