A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin (A)/Cyclophosphamide ©) and/or Weekly Paclitaxel
18 Years
N/A
Female
Breast Cancer
Trial Information
A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin (A)/Cyclophosphamide ©) and/or Weekly Paclitaxel
OBJECTIVES:
Primary
- 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.
Secondary
- 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 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:
- Node negative disease AND meets 1 of the following stage criteria:
- Primary tumor > T1c
- Primary tumor > T1b AND poor prognostic features, defined as the following:
- High-grade disease
- HER2/neu-positive disease by fluorescence in situ hybridization
- Estrogen receptor-negative disease
- Stage II disease (T2, N0)
- Node positive nonmetastatic disease
- Locally advanced disease AND receiving neoadjuvant chemotherapy comprising
doxorubicin and cyclophosphamide OR paclitaxel
- Enrolled in clinical trial CALGB-40101
- No evidence of systemic metastasis
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin < 2.0 times upper limit of normal
Renal
- Creatinine < 2.0 mg/dL
Cardiovascular
- No ischemic heart disease
- No uncontrolled hypertension
Other
- Not pregnant
- No poorly controlled diabetes mellitus
- No active infection
- No peripheral neuropathy ≥ grade 2
- No other serious comorbidity
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent anticancer immunotherapy or biologic response modifiers
- No concurrent growth factors during course 1 of doxorubicin and cyclophosphamide
study treatment
Chemotherapy
- See Disease Characteristics
- No prior weekly paclitaxel
Endocrine therapy
- No concurrent anticancer endocrine therapy
Radiotherapy
- Concurrent radiotherapy to the chest wall allowed for patients receiving paclitaxel
only
Surgery
- At least 2 weeks since prior major surgery (e.g., wide excision, lumpectomy, or
mastectomy)
Other
- More than 2 weeks since prior and no concurrent CYP450 inducers or inhibitors
- No other concurrent anticancer cytotoxic therapy
- No other concurrent investigational drugs
- No other concurrent medications known to cause myelosuppression (e.g., neutropenia)
or neuropathy
- No concurrent participation in another clinical trial except for patients receiving
adjuvant doxorubicin and cyclophosphamide on protocols CALGB-40101 or MA-21
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pharmacogenomics of doxorubicin, cyclophosphamide, and paclitaxel
Safety Issue:
No
Principal Investigator
Paul K. Marcom, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Duke Cancer Institute
Authority:
Unspecified
Study ID:
CDR0000438673
NCT ID:
NCT00131963
Start Date:
October 2003
Completion Date:
Related Keywords:
- Breast Cancer
- stage IA breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IB breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Duke Cancer Institute | Durham, North Carolina 27710 |
