Antioxidant Supplements, Genetics and Chemotherapy Outcomes

This study will enroll 3000 women from S0221with node positive or high-risk node-negative breast cancer receiving AC+T onto this ancillary study to address the following specific aims:

• To characterize use of antioxidant supplements with a survey instrument prior to and at completion of treatment, and to evaluate reported use pre and post treatment in relation to toxicity and disease-free survival. The potential effects of diet, physical activity, and other lifestyle factors on relationships between supplement use and treatment outcomes will also be considered.
• To evaluate if variants (polymorphisms) in genes that produce reactive oxygen species (ROS) (MPO) and in genes that protect cells from the effects of ROS are associated with treatment-related toxicities and with disease-free survival.

Inclusion criteria

• Histologically confirmed diagnosis of operable Stage 1, II, or III invasive breast cancer with known estrogen or progesterone receptor status
• high risk by meeting at least one of the following criteria:

• tumor >= 2 cm in greatest diameter
• one or more axillary or intramammary nodes are involved by metastatic breast cancer
• had either a modified radical mastectomy or local excision of all tumors plus axillary node dissection or sentinel node resection
• not received prior chemotherapy or radiation therapy for the current malignancy
• no history of congestive heart failure or angina pectoris
• normal creatinine and bilirubin, alkaline phosphatase and SGOT or SGPT 2 x the institutional upper limits of normal
• ANC greater than or equal to 1,200 ul and platelet count of greater than or equal 100,000 U1
• No previous malignancies
• Age 18 or greater
• Performance status of 0 -2 by Zubrod criteria
• HIV negative (if known)