Doxorubicin, Cyclophosphamide, and/or Paclitaxel in Treating Women With Nonmetastatic Breast Cancer
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, and/or paclitaxel work in treating women with nonmetastatic breast cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin (A)/Cyclophosphamide ©) and/or Weekly Paclitaxel|
- Treatment-induced myelosuppression (e.g., neutropenia) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Incidence of peripheral neuropathy [ Time Frame: 12 month ] [ Designated as safety issue: No ]
- Response (relapse in adjuvant setting) for 10 years after completion of study treatment [ Time Frame: Ten years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2003|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: 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.
Other Name: CytoxanDrug: doxorubicin
Other Name: adriamycin
Experimental: Regimen 2
Patients receive doxorubicin and cyclophosphamide as in regimen 1. Patients then receive paclitaxel IV over 1 hour once weekly for 12 weeks.
Other Name: CytoxanDrug: doxorubicin
Other Name: adriamycinDrug: paclitaxel
Other Name: taxol
- Determine the pharmacogenomics of adjuvant chemotherapy comprising doxorubicin and cyclophosphamide and/or paclitaxel in women with nonmetastatic invasive breast cancer.
- Determine treatment-induced myelosuppression (e.g., 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.
- Determine response (i.e., 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 study(CALGB) 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131963
|United States, North Carolina|
|Duke Cancer Institute|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Paul K. Marcom, MD||Duke Cancer Institute|