Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475670
Status:
COMPLETED
Last Update Posted:
2014-09-15
First Post:
2007-05-17
Brief Title:
A Study of Herceptin Trastuzumab in Women With Metastatic Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-label Study of the Effect of First-line Herceptin Alone or in Combination With a Taxane on Tumor Response and Disease Progression in Patients With Metastatic Breast Cancer Who Relapsed After Receiving Adjuvant Herceptin for HER2-positive Early Breast Cancer
Status:
COMPLETED
Status Verified Date:
2014-09
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:
This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10 months of neoadjuvant treatment with Herceptin for HER2-positive early breast cancerPatients will receive either Herceptin monotherapy loading dose of 4mgkg iv followed by weekly doses of 2mgkg iv or 8mgkg loading dose followed by 3-weekly doses of 6mgkgor Herceptin a taxane docetaxel 100mgm2 iv every 3 weeks or paclitaxel 175mgm2 iv every 3 weeks or 75mgm2 every week The anticipated time on study treatment is until disease progression and the target sample size is 100 individuals
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