Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131963
Status:
COMPLETED
Last Update Posted:
2016-07-25
First Post:
2005-08-16
Brief Title:
A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin ACyclophosphamide andor Weekly Paclitaxel
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin ACyclophosphamide andor Weekly Paclitaxel
Status:
COMPLETED
Status Verified Date:
2015-11
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 such as doxorubicin cyclophosphamide and paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Giving chemotherapy after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well doxorubicin cyclophosphamide andor paclitaxel work in treating women with nonmetastatic breast cancer
PURPOSE This phase II trial is studying how well doxorubicin cyclophosphamide andor paclitaxel work in treating women with nonmetastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the pharmacogenomics of adjuvant chemotherapy comprising doxorubicin and cyclophosphamide andor paclitaxel in women with nonmetastatic invasive breast cancer
Determine treatment-induced myelosuppression eg neutropenia in patients treated with adjuvant doxorubicin and cyclophosphamide who have polymorphisms in drug activation and metabolism genes
Correlate the incidence of peripheral neuropathy with pharmacogenomic analysis in patients treated with paclitaxel
Secondary
Determine response ie relapse in the adjuvant setting during a 10-year follow-up period in patients treated with these regimens
OUTLINE This is a multicenter study Patients receive treatment on The Cancer and Leukemia Group B studyCALGB CALGB-40101 OR are assigned to receive 1 of 2 treatment regimens on this study
Regimen 1 Patients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over 30 minutes on day 1 Treatment repeats every 21 days for 4 courses
Regimen 2 Patients receive doxorubicin and cyclophosphamide as in regimen 1 Patients then receive paclitaxel IV over 1 hour once weekly for 12 weeks
After completion of study treatment patients are followed at 3 6 and 12 months and then annually for up to 10 years
PROJECTED ACCRUAL A total of 500 patients 300 treated with doxorubicin and cyclophosphamide and 200 treated with paclitaxel will be accrued for this study within 3-4 years
Primary
Determine the pharmacogenomics of adjuvant chemotherapy comprising doxorubicin and cyclophosphamide andor paclitaxel in women with nonmetastatic invasive breast cancer
Determine treatment-induced myelosuppression eg neutropenia in patients treated with adjuvant doxorubicin and cyclophosphamide who have polymorphisms in drug activation and metabolism genes
Correlate the incidence of peripheral neuropathy with pharmacogenomic analysis in patients treated with paclitaxel
Secondary
Determine response ie relapse in the adjuvant setting during a 10-year follow-up period in patients treated with these regimens
OUTLINE This is a multicenter study Patients receive treatment on The Cancer and Leukemia Group B studyCALGB CALGB-40101 OR are assigned to receive 1 of 2 treatment regimens on this study
Regimen 1 Patients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over 30 minutes on day 1 Treatment repeats every 21 days for 4 courses
Regimen 2 Patients receive doxorubicin and cyclophosphamide as in regimen 1 Patients then receive paclitaxel IV over 1 hour once weekly for 12 weeks
After completion of study treatment patients are followed at 3 6 and 12 months and then annually for up to 10 years
PROJECTED ACCRUAL A total of 500 patients 300 treated with doxorubicin and cyclophosphamide and 200 treated with paclitaxel will be accrued for this study within 3-4 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 |
|---|---|---|---|
| CDR0000438673 | OTHER | National Cancer Institute | None |
| DUMC-4522-04-1-R1 | OTHER | None | None |