Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003440
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
1999-11-01
Brief Title:
Paclitaxel With or Without Trastuzumab in Treating Patients With or Without HER-2Neu Breast Cancer That is Inoperable Recurrent or Metastatic
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of Paclitaxel Via Weekly 1 Hour Infusion Versus Standard 3 Hour Infusion Every 3 Weeks With Herceptin Trastuzumab NSC 688097 in the Treatment of Patients WithWithout HER-2Neu-Overexpressing Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This randomized phase III studies how well two different regimens of paclitaxel with or without trastuzumab works in treating patients with or without HER-2Neu breast cancer that is inoperable recurrent or metastatic Drugs used in chemotherapy such as paclitaxel 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 It is not yet known what regimen of paclitaxel is more effective with or without trastuzumab in treating patients with breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether dose dense DD treatment with paclitaxel via weekly 1-hour infusion has a significantly higher response rate than standard S paclitaxel treatment regardless of human epidermal growth factor receptor 2 HER-2neu status and assignment to Herceptin trastuzumab
II To determine if the addition of Herceptin to DD or S paclitaxel significantly improves the response rate as compared to DD or S paclitaxel alone for HER-2neu non-overexpressing metastatic breast cancer eg 0 or 1
III To determine whether the addition of Herceptin to chemotherapy treatment modifies the quality of life experienced by patients with HER-2neu non-overexpressing metastatic breast cancer
IV To determine whether the quality of life experienced by patients with metastatic breast cancer who have been treated with standard paclitaxel treatment differ from that of patients treated with dose dense paclitaxel treatment
V To correlate amplification and overexpression of the growth factor receptor ErbB2 by immunohistochemistry and fluorescent in-situ hybridization FISH with response rate time to progression and overall survival of patients with metastatic breast cancer treated with paclitaxel chemotherapy and paclitaxel Herceptin
VI To correlate ErbB2 shed extracellular domain ECD with response rate time to progression and overall survival of patients with metastatic breast cancer treated with different doses and schedules of paclitaxel and paclitaxel Herceptin In addition to follow patterns of ErbB2ECD after treatment and upon relapse
SECONDARY OBJECTIVES
I To evaluate time to progression and survival of patients with HER-2 overexpressing metastatic breast cancer treated with either DD or S paclitaxel plus weekly Herceptin
II To evaluate time to progression and survival of patients with HER-2 non-overexpressing metastatic breast cancer treated with either DD or S paclitaxel alone or DD or S paclitaxel plus weekly Herceptin
III To evaluate cardiac toxicity as measured by changes in LVEF from baseline to follow-up measurements
OUTLINE Patients are assigned to 1 of 2 treatment groups
GROUP I HER2neu non-overexpressors Patients are randomized to 1 of 4 treatment arms
ARM A Patients receive paclitaxel intravenously IV over 3 hours every 3 weeks
ARM B Patients receive paclitaxel IV over 1 hour weekly
ARM C Patients receive paclitaxel as in Arm A Patients also receive trastuzumab IV weekly
ARM D Patients receive paclitaxel as in Arm B and trastuzumab as in Arm C
GROUP II HER2neu overexpression Patients are assigned to 1 of 2 treatment arms
ARM E Patients receive paclitaxel and trastuzumab as in Arm C
ARM F Patients receive paclitaxel and trastuzumab as in Arm D
In all arms courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
After the completion of study treatment patients are followed up periodically for up to 5 years
I To determine whether dose dense DD treatment with paclitaxel via weekly 1-hour infusion has a significantly higher response rate than standard S paclitaxel treatment regardless of human epidermal growth factor receptor 2 HER-2neu status and assignment to Herceptin trastuzumab
II To determine if the addition of Herceptin to DD or S paclitaxel significantly improves the response rate as compared to DD or S paclitaxel alone for HER-2neu non-overexpressing metastatic breast cancer eg 0 or 1
III To determine whether the addition of Herceptin to chemotherapy treatment modifies the quality of life experienced by patients with HER-2neu non-overexpressing metastatic breast cancer
IV To determine whether the quality of life experienced by patients with metastatic breast cancer who have been treated with standard paclitaxel treatment differ from that of patients treated with dose dense paclitaxel treatment
V To correlate amplification and overexpression of the growth factor receptor ErbB2 by immunohistochemistry and fluorescent in-situ hybridization FISH with response rate time to progression and overall survival of patients with metastatic breast cancer treated with paclitaxel chemotherapy and paclitaxel Herceptin
VI To correlate ErbB2 shed extracellular domain ECD with response rate time to progression and overall survival of patients with metastatic breast cancer treated with different doses and schedules of paclitaxel and paclitaxel Herceptin In addition to follow patterns of ErbB2ECD after treatment and upon relapse
SECONDARY OBJECTIVES
I To evaluate time to progression and survival of patients with HER-2 overexpressing metastatic breast cancer treated with either DD or S paclitaxel plus weekly Herceptin
II To evaluate time to progression and survival of patients with HER-2 non-overexpressing metastatic breast cancer treated with either DD or S paclitaxel alone or DD or S paclitaxel plus weekly Herceptin
III To evaluate cardiac toxicity as measured by changes in LVEF from baseline to follow-up measurements
OUTLINE Patients are assigned to 1 of 2 treatment groups
GROUP I HER2neu non-overexpressors Patients are randomized to 1 of 4 treatment arms
ARM A Patients receive paclitaxel intravenously IV over 3 hours every 3 weeks
ARM B Patients receive paclitaxel IV over 1 hour weekly
ARM C Patients receive paclitaxel as in Arm A Patients also receive trastuzumab IV weekly
ARM D Patients receive paclitaxel as in Arm B and trastuzumab as in Arm C
GROUP II HER2neu overexpression Patients are assigned to 1 of 2 treatment arms
ARM E Patients receive paclitaxel and trastuzumab as in Arm C
ARM F Patients receive paclitaxel and trastuzumab as in Arm D
In all arms courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
After the completion of study treatment patients are followed up periodically 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-9840 | None | None | None |