Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004888
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2000-03-07
Brief Title:
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Safety and Efficacy Study of Doxil and Taxotere Herceptin in Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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:
Phase II trial to study the effectiveness of combination chemotherapy with or without trastuzumab in treating women who have metastatic breast cancer Drugs used in chemotherapy use 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
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety and feasibility of the combination of liposomal doxorubicin Doxil and Taxotere Taxotere trastuzumab Herceptin particularly with respect to cardiotoxicity
II To evaluate the overall objective response rate response duration time to treatment failure and median survival of patients with metastatic breast cancer treated with Doxil and Taxotere Herceptin
III To determine the overall toxicity of Doxil and Taxotere Herceptin in patients with advanced breast cancer
IV To determine whether there is an association between trough plasma levels of cTnT cardiac troponin T and NT-proBNP brain natriuretic peptide and any cardiac event CHF or LVEF decrease
V To determine tissue and plasma levels of HER2 using several assays and explore potential correlation with protocol treatment toxicity andor response
OUTLINE Patients are assigned to one of two treatment arms according to HER2 overexpression status
Arm I HER2 nonoverexpressed Patients receive doxorubicin hydrochloride liposome IV over 30 minutes followed by docetaxel IV over 1 hour Treatment is repeated every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity
Patients may receive maintenance therapy of docetaxel IV over 1 hour either weekly or every 3 weeks Maintenance continues in the absence of disease progression or unacceptable toxicity
Arm II HER2 overexpressed Patients receive trastuzumab IV over 90 minutes on day 1 with subsequent doses over 30 minutes Patients receive doxorubicin HCl liposome IV over 30 minutes followed by docetaxel IV over 1 hour on day 2 of course 1 followed by subsequent doses on day 1 of each course Antibody therapy continues weekly and chemotherapy every 3 weeks for 8 courses
Patients may receive maintenance therapy of trastuzumab IV over 30 minutes weekly followed by docetaxel IV over 1 hour weekly or every 3 weeks Maintenance continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 89 patients were accrued for this study
I To evaluate the safety and feasibility of the combination of liposomal doxorubicin Doxil and Taxotere Taxotere trastuzumab Herceptin particularly with respect to cardiotoxicity
II To evaluate the overall objective response rate response duration time to treatment failure and median survival of patients with metastatic breast cancer treated with Doxil and Taxotere Herceptin
III To determine the overall toxicity of Doxil and Taxotere Herceptin in patients with advanced breast cancer
IV To determine whether there is an association between trough plasma levels of cTnT cardiac troponin T and NT-proBNP brain natriuretic peptide and any cardiac event CHF or LVEF decrease
V To determine tissue and plasma levels of HER2 using several assays and explore potential correlation with protocol treatment toxicity andor response
OUTLINE Patients are assigned to one of two treatment arms according to HER2 overexpression status
Arm I HER2 nonoverexpressed Patients receive doxorubicin hydrochloride liposome IV over 30 minutes followed by docetaxel IV over 1 hour Treatment is repeated every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity
Patients may receive maintenance therapy of docetaxel IV over 1 hour either weekly or every 3 weeks Maintenance continues in the absence of disease progression or unacceptable toxicity
Arm II HER2 overexpressed Patients receive trastuzumab IV over 90 minutes on day 1 with subsequent doses over 30 minutes Patients receive doxorubicin HCl liposome IV over 30 minutes followed by docetaxel IV over 1 hour on day 2 of course 1 followed by subsequent doses on day 1 of each course Antibody therapy continues weekly and chemotherapy every 3 weeks for 8 courses
Patients may receive maintenance therapy of trastuzumab IV over 30 minutes weekly followed by docetaxel IV over 1 hour weekly or every 3 weeks Maintenance continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 89 patients were accrued for this study
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 |
|---|---|---|---|
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2012-02949 | REGISTRY | None | None |
| E3198 | OTHER | None | None |
| E3198 | OTHER | None | None |