Heavy Metal Exposure in Predicting Peripheral Neuropathy in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy

PRIMARY OBJECTIVES:

I. To describe the correlation, if any, of specific heavy metals with high grade symptoms of
peripheral neuropathy, defined as grade >= 3 peripheral neuropathy, (utilizing the Common
Terminology Criterial for Adverse Events [CTCAE] version [v.] 4.0) in a cohort of breast
cancer patients undergoing (neo)adjuvant taxane chemotherapy.

SECONDARY OBJECTIVES:

I. To characterize the range of specific heavy metals in a cohort of breast cancer patients
undergoing (neo)adjuvant chemotherapy treatment.

II. To evaluate the reproducibility of sera and urine testing of heavy metal levels by
inductively coupled plasma mass spectrometry (ICP-MS) testing in a cohort of breast cancer
patients undergoing (neo)adjuvant taxane chemotherapy.

OUTLINE:

Patients undergo serum and urine sample collection for heavy metal analysis by ICP-MS at
baseline and at the completion of treatment. Patients also complete neurotoxicity assessment
questionnaire at baseline and at the completion of treatment.

Inclusion Criteria:

- Patients must have histologically confirmed invasive mammary carcinoma; any
histologic sub-type allowed

- Patients must be diagnosed with stage I, II or III breast cancer

- Patients must be undergoing treatment with an adjuvant or neoadjuvant cytotoxic
chemotherapy that includes a taxane, specifically paclitaxel, nab-paclitaxel
(Abraxane), or docetaxel

- Patients may have received prior endocrine and/or radiation therapy

- Patients must have the ability to understand and the willingness to sign a written
informed consent document

Exclusion Criteria:

- Patients who have been previously treated with cytotoxic chemotherapy

- Patients with pre-existing peripheral neuropathy