Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-28 @ 6:14 AM
Study NCT ID:
NCT00453635
Status:
TERMINATED
Last Update Posted:
2012-03-13
First Post:
2007-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
Sponsor:
Hellenic Oncology Research Group
Organization:
Study Overview
Official Title:
A Multicenter Randomized Phase II Study of First Line Treatment With Sequential Administration of Docetaxel, Carboplatin and Herceptin Versus the Administration of Vinorelbine and Herceptin Combination in HER-2 Positive Patients With Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer.
Detailed Description:
Herceptin, a humanized monoclonal antibody directed against the extracellular domain of the transmembrane glycoprotein HER2/neu (c-erbB-2), is a valuable option in the treatment of women with HER2-positive metastatic breast cancer. The combination of Herceptin and chemotherapy yielded significantly better results than chemotherapy alone in response, time to progression, and survival time. Whether the combination of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination in HER-2 positive patients with metastatic breast cancer is preferable is not yet known.
Study Oversight
Has Oversight DMC:
False
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?: