Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079326
Status:
TERMINATED
Last Update Posted:
2014-06-02
First Post:
2004-03-08
Brief Title:
Trastuzumab and Ixabepilone in Treating Women With HER2-Positive Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of Trastuzumab in Combination With BMS-247550 in Women With Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying how well giving trastuzumab together with ixabepilone works in treating women with HER2-positive metastatic breast cancer Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy such as ixabepilone work in different ways to stop tumor cells from dividing so they stop growing or die Combining trastuzumab with ixabepilone may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Examine the response rate of HER2-positive metastatic breast cancer to combination therapy with trastuzumab and BMS-247550 in two cohorts of women a women who have received no prior chemotherapy or trastuzumab for their metastatic breast cancer b women who have received prior trastuzumab therapy either for metastatic disease or prior adjuvant trastuzumab if 1 year since completion of adjuvant trastuzumab therapy and up to 2 prior chemotherapeutic regimens in the metastatic setting
SECONDARY OBJECTIVES
I To characterize the safety and toxicity profile of trastuzumab in combination with BMS-247550
II To determine the time-to-disease-progression TTP and time-to-treatment-failure TTF for patients receiving trastuzumab in combination with BMS-247550 in each cohort
III Analyze various tissue biomarkers eg HER2phospho-HER2 EGFRphospho-EGFR IGRF-I phospho-MAPK phospho-P13K bcl-2 bcl-xL MDR-1 MRP and β-tubulin and blood biomarkers HER2-extracellular domain ECD circulating tumor cells to correlate them with response to treatment
OUTLINE This is an open-label multicenter study Patients are stratified according to prior trastuzumab Herceptin therapy with or without chemotherapy for metastatic breast cancer yes vs no
Patients receive trastuzumab IV over 30-90 minutes and ixabepilone IV over 3 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
I Examine the response rate of HER2-positive metastatic breast cancer to combination therapy with trastuzumab and BMS-247550 in two cohorts of women a women who have received no prior chemotherapy or trastuzumab for their metastatic breast cancer b women who have received prior trastuzumab therapy either for metastatic disease or prior adjuvant trastuzumab if 1 year since completion of adjuvant trastuzumab therapy and up to 2 prior chemotherapeutic regimens in the metastatic setting
SECONDARY OBJECTIVES
I To characterize the safety and toxicity profile of trastuzumab in combination with BMS-247550
II To determine the time-to-disease-progression TTP and time-to-treatment-failure TTF for patients receiving trastuzumab in combination with BMS-247550 in each cohort
III Analyze various tissue biomarkers eg HER2phospho-HER2 EGFRphospho-EGFR IGRF-I phospho-MAPK phospho-P13K bcl-2 bcl-xL MDR-1 MRP and β-tubulin and blood biomarkers HER2-extracellular domain ECD circulating tumor cells to correlate them with response to treatment
OUTLINE This is an open-label multicenter study Patients are stratified according to prior trastuzumab Herceptin therapy with or without chemotherapy for metastatic breast cancer yes vs no
Patients receive trastuzumab IV over 30-90 minutes and ixabepilone IV over 3 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| N01CM62206 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62206 |
| NCI-2012-03123 | REGISTRY | None | None |
| CDR0000355176 | None | None | None |
| 03-202 | OTHER | None | None |
| 6297 | OTHER | None | None |
| P30CA006516 | NIH | None | None |