Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00364611
Status:
COMPLETED
Last Update Posted:
2012-08-23
First Post:
2006-08-14
Brief Title:
Pilot Study of Docetaxel Bevacizumab - Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Pilot Phase II Multicenter Open-Label Prospective Evaluation of Docetaxel and Bevacizumab Trastuzumab in the First-Line Treatment of Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-04
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:
Pilot phase II parallel-group open-label noncomparative prospective multicenter study designed to evaluate the progression-free survival of docetaxel and bevacizumab trastuzumab for the first-line treatment of participants with metastatic breast cancer Participants were stratified according to human epidermal growth factor receptor-2 HER2 status at the time of enrollment HER2 negative participants were assigned to receive docetaxel and bevacizumab DB HER2 positive participants were assigned to receive docetaxel bevacizumab and trastuzumab DBT
All participants except one were off study treatment on 30 June 2011 All efficacy analysis and safety analysis was performed using the cut-off date of June 2011 One participant continued treatment till 11 March 2012 For this participant adverse events were collected upto 19 April 2012 and included in the safety analysis
All participants except one were off study treatment on 30 June 2011 All efficacy analysis and safety analysis was performed using the cut-off date of June 2011 One participant continued treatment till 11 March 2012 For this participant adverse events were collected upto 19 April 2012 and included in the safety analysis
Detailed Description:
The study included
Study registration on Day 1 Treatment Cycle 1 was initiated within 14 days of signing informed consent
Treatment was administered in 3 week treatment cycles until the participant developed unacceptable toxicity had disease progression withdrew consent or died
If participants experienced a complete response CR partial response PR or stable disease SD at Cycle 8 or beyond or had unacceptable toxicity due to docetaxel they could continue on bevacizumab andor trastuzumab until they developed unacceptable toxicity had disease progression or withdrew consent
Participants had follow-up assessments within 30 days after discontinuation of treatment with the last of the study drugs for any reason other than death
Study registration on Day 1 Treatment Cycle 1 was initiated within 14 days of signing informed consent
Treatment was administered in 3 week treatment cycles until the participant developed unacceptable toxicity had disease progression withdrew consent or died
If participants experienced a complete response CR partial response PR or stable disease SD at Cycle 8 or beyond or had unacceptable toxicity due to docetaxel they could continue on bevacizumab andor trastuzumab until they developed unacceptable toxicity had disease progression or withdrew consent
Participants had follow-up assessments within 30 days after discontinuation of treatment with the last of the study drugs for any reason other than death
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