Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093808
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2004-10-06
Brief Title:
Capecitabine Vinorelbine and Trastuzumab in Treating Patients With Metastatic Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Study of Capecitabine in Combination With Vinorelbine and Trastuzumab for the First- or Second-LineTreatment of HER2 Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-01
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:
RATIONALE Drugs used in chemotherapy such as capecitabine and vinorelbine work in different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells Giving capecitabine and vinorelbine together with trastuzumab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving capecitabine and vinorelbine together with trastuzumab works in treating patients who have metastatic breast cancer
PURPOSE This phase II trial is studying how well giving capecitabine and vinorelbine together with trastuzumab works in treating patients who have metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the overall response rate in patients with HER2neu-overexpressing metastatic breast cancer treated with first- or second-line therapy comprising capecitabine vinorelbine and trastuzumab Herceptin
Secondary
Determine the time to disease progression duration of response and overall survival of patients treated with this regimen
Determine the safety profile of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral capecitabine twice daily on days 1-14 vinorelbine IV over 6-10 minutes on days 1 and 8 and trastuzumab Herceptin IV over 30-90 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years
Primary
Determine the overall response rate in patients with HER2neu-overexpressing metastatic breast cancer treated with first- or second-line therapy comprising capecitabine vinorelbine and trastuzumab Herceptin
Secondary
Determine the time to disease progression duration of response and overall survival of patients treated with this regimen
Determine the safety profile of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral capecitabine twice daily on days 1-14 vinorelbine IV over 6-10 minutes on days 1 and 8 and trastuzumab Herceptin IV over 30-90 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years
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 |
|---|---|---|---|
| CDR0000390344 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02625 | REGISTRY | None | None |