Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003612
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Randomized Phase II Trial of Paclitaxel Carboplatin and rhuMAb Her-2 Herceptin as First-Line Chemotherapy in Patients With Metastatic Breast Cancer Who Overexpress Her-2
Status:
COMPLETED
Status Verified Date:
2019-10
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of combining paclitaxel carboplatin and trastuzumab in treating women who have metastatic breast cancer that overexpresses HER2
PURPOSE Phase II trial to study the effectiveness of combining paclitaxel carboplatin and trastuzumab in treating women who have metastatic breast cancer that overexpresses HER2
Detailed Description:
OBJECTIVES
Compare the response rate associated with two different treatment schedules of paclitaxel carboplatin and trastuzumab Herceptin in women with overexpressed HER-2 growth factor receptor and metastatic breast cancer Schedule A closed to accrual effective 05162003
Compare the time to progression and median survival in patients treated with these schedules
Compare the toxicity of these treatment schedules in these patients
OUTLINE This is a multicenter study Patients are stratified according to prior adjuvant therapy none vs less than 6 months vs at least 6 months estrogen receptor ER status and progesterone receptor PR status at initial diagnosis ER positivePR positive or unknown vs ER positivePR negative vs ER positive or unknownPR negative menopausal status pre vs post and performance status 0 or 1 vs 2 Patients are assigned to 1 of 2 treatment schedules
Schedule A Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes and then trastuzumab Herceptin IV over 90 minutes on day 1 of week 1 Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity Patients then receive trastuzumab IV over 30 minutes every 3 weeks until disease progression Schedule A closed to accrual effective 05162003
Schedule B Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 15 minutes on day 1 of weeks 1-3 and trastuzumab IV over 90 minutes immediately after carboplatin on day 1 Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients then receive trastuzumab IV over 30 minutes every 3 weeks until disease progression
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 36-92 patients 18-46 per treatment schedule will be accrued for this study within 7-185 months Schedule A closed to accrual effective 05162003
Compare the response rate associated with two different treatment schedules of paclitaxel carboplatin and trastuzumab Herceptin in women with overexpressed HER-2 growth factor receptor and metastatic breast cancer Schedule A closed to accrual effective 05162003
Compare the time to progression and median survival in patients treated with these schedules
Compare the toxicity of these treatment schedules in these patients
OUTLINE This is a multicenter study Patients are stratified according to prior adjuvant therapy none vs less than 6 months vs at least 6 months estrogen receptor ER status and progesterone receptor PR status at initial diagnosis ER positivePR positive or unknown vs ER positivePR negative vs ER positive or unknownPR negative menopausal status pre vs post and performance status 0 or 1 vs 2 Patients are assigned to 1 of 2 treatment schedules
Schedule A Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes and then trastuzumab Herceptin IV over 90 minutes on day 1 of week 1 Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity Patients then receive trastuzumab IV over 30 minutes every 3 weeks until disease progression Schedule A closed to accrual effective 05162003
Schedule B Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 15 minutes on day 1 of weeks 1-3 and trastuzumab IV over 90 minutes immediately after carboplatin on day 1 Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients then receive trastuzumab IV over 30 minutes every 3 weeks until disease progression
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 36-92 patients 18-46 per treatment schedule will be accrued for this study within 7-185 months Schedule A closed to accrual effective 05162003
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 |
|---|---|---|---|
| CDR0000066689 | REGISTRY | PDQ Physician Data Query | None |