Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103233
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2005-02-07
Brief Title:
Vinorelbine With or Without Trastuzumab in Treating Women With Progressive Metastatic Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Study of Weekly Vinorelbine Navelbine Alone or in Combination With Trastuzumab Herceptin NSC-688097 for Patients With HER-2-Positive Metastatic Breast Cancer Whose Tumors Have Progressed After Taxane Trastuzumab Combination Therapy - Phase III
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as vinorelbine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as trastuzumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Trastuzumab may also help vinorelbine work better by making tumor cells more sensitive to the drug Giving vinorelbine together with trastuzumab may be an effective treatment for breast cancer It is not yet known whether giving vinorelbine together with trastuzumab is more effective than vinorelbine alone in treating breast cancer
PURPOSE This randomized phase III trial is studying vinorelbine and trastuzumab to see how well they work compared to vinorelbine alone in treating women with progressive metastatic breast cancer
PURPOSE This randomized phase III trial is studying vinorelbine and trastuzumab to see how well they work compared to vinorelbine alone in treating women with progressive metastatic breast cancer
Detailed Description:
OBJECTIVES
Compare progression-free survival PFS of women with HER2-positive progressive metastatic breast cancer treated with vinorelbine with or without trastuzumab Herceptin
Compare overall survival and time to treatment failure in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the response rate complete and partial confirmed and unconfirmed in patients with measurable disease treated with these regimens
Correlate baseline circulating tumor cells CTC with PFS overall survival and disease progression status at 9 weeks in patients treated with these regimens
Correlate 4-week CTC with subsequent PFS and overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive trastuzumab Herceptin IV over 90 minutes and vinorelbine IV over 10 minutes on day 1 of course 1 Patients receive trastuzumab IV over 30 minutes and vinorelbine IV over 10 minutes on days 1 8 15 and 22 in all subsequent courses If trastuzumab is discontinued due to toxicity patients may continue to receive vinorelbine alone
Arm II Patients receive vinorelbine IV over 10 minutes on days 1 8 15 and 22
In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months until disease progression and then every 6 months for up to 3 years
PROJECTED ACCRUAL A total of 292 patients 146 per treatment arm will be accrued for this study within 3 years
Compare progression-free survival PFS of women with HER2-positive progressive metastatic breast cancer treated with vinorelbine with or without trastuzumab Herceptin
Compare overall survival and time to treatment failure in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the response rate complete and partial confirmed and unconfirmed in patients with measurable disease treated with these regimens
Correlate baseline circulating tumor cells CTC with PFS overall survival and disease progression status at 9 weeks in patients treated with these regimens
Correlate 4-week CTC with subsequent PFS and overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive trastuzumab Herceptin IV over 90 minutes and vinorelbine IV over 10 minutes on day 1 of course 1 Patients receive trastuzumab IV over 30 minutes and vinorelbine IV over 10 minutes on days 1 8 15 and 22 in all subsequent courses If trastuzumab is discontinued due to toxicity patients may continue to receive vinorelbine alone
Arm II Patients receive vinorelbine IV over 10 minutes on days 1 8 15 and 22
In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months until disease progression and then every 6 months for up to 3 years
PROJECTED ACCRUAL A total of 292 patients 146 per treatment arm will be accrued for this study within 3 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 |
|---|---|---|---|
| SWOG-S0347 | None | None | None |