A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin (A)/Cyclophosphamide ©) and/or Weekly Paclitaxel

Eligibility Criteria

Histologically confirmed invasive breast cancer
node negative stage > T1c or T1b with poor prognostic features (high grade, Her2/neu FISH positive, ER negative) or stage 2 (T2, N0) or
enrolled on CALGB 40101, CALGB 49909, or the National Cancer Institute of Canada study MA-21 or
any node positive patient or locally advanced undergoing neoadjuvant chemotherapy with either AC or paclitaxel
Age greater than or equal to 18 years.
>/=2 weeks from major surgery (wide excision / lumpectomy / mastectomy)
No evidence of systemic metastasis
Undergoing adjuvant treatment with standard dose AC or AC followed by weekly Paclitaxel at 80mg/m2
Adequate bone marrow, hepatic and renal functions (absolute neutrophil count >1,500/ μl, platelet count > 100,000/ μl, serum creatinine <2.0 mg/dl, total Bilirubin <2.0 x the upper limit of normal (ULN)
Ability to answer and understand study surveillance questionnaires
No concurrent drug therapy (within 2 weeks) with agents that are known inducers or inhibitors of Cytochrome P450 (CYP450).

Exclusion Criteria

Other anticancer cytotoxic or endocrine therapy, immunotherapy, or biologic response modifiers,Study Drugs or other concomitant medications known to cause myelosuppression especially neutropenia and neuropathy
Eastern Cooperative Oncology Group Performance Status(ECOG) functional status > 2.
Serious co-morbidities including poorly controlled diabetes mellitus, ischaemic heart disease,uncontrolled hypertension or active infection.
Pregnancy
Use of growth factor during cycle 1 of chemotherapy (AC) under pharmacokinetic evaluation
Grade >/=2 peripheral neuropathy symptoms based on National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) Scale. Exception: a chronic neurologic disorder will be reviewed on a case by case basis by the study PI.

Prior treatment with weekly paclitaxelDISEASE 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
Human Epidermal Growth Factor Receptor 2 (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