Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431704
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-24
First Post:
2007-02-05
Brief Title:
VinCaT Vinorelbine Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer
Sponsor:
National Cancer Institute Naples
Organization:
National Cancer Institute Naples
Study Overview
Official Title:
Vinorelbine Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer a Phase 2 Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
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:
VinCaT
Brief Summary:
The purpose of this study is to evaluate the activity and safety of the combination of vinorelbine carboplatin and trastuzumab in HER2-positive metastatic breast cancer
Detailed Description:
The addition of trastuzumab to chemotherapy containing anthracyclines or taxanes has improved survival in patients with Her-2 positive metastatic breast cancer but newer combinations with less toxicity and cross resistance are needed Early clinical studies have suggested that the combination of vinorelbine carboplatin and trastuzumab can be active against metastatic breast cancer with less toxicity In this phase II single center trial 39 patients will be enrolled to evaluate the activity and safety of this combination
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 |
|---|---|---|---|
| 2006-003994-28 | EUDRACT_NUMBER | None | None |