Effect of Surgery, Radiation Therapy, Chemotherapy, and Hormone Therapy on Biomarkers in Women With Stage I, Stage II, Stage III Breast Cancer, or Ductal Carcinoma In Situ That Can Be Removed By Surgery

OBJECTIVES:

- Measure the effects of surgery and radiation on concentrations of high-sensitivity
C-reactive protein (hsCRP) in women with newly diagnosed stage I-III invasive breast
cancer or ductal carcinoma in situ.

- Measure the effects of chemotherapy and/or endocrine therapy on concentrations of hsCRP
in these patients.

- Summarize the differences in preoperative to peri-chemotherapy hsCRP concentrations
separately for patients who do and who do not receive growth factors during
chemotherapy.

- Observe the change in hsCRP concentrations and gene methylation over time with local
and systemic treatment in these patients.

- Explore prevalence of baseline and change in methylation in a panel of genes that is
known to be frequently and specifically hypermethylated in breast cancer.

OUTLINE: This is a prospective study.

A blood sample is collected at baseline, approximately 1 week after surgery, and at the time
of a routine follow-up visit 3-6 months after completion of all local and systemic therapy,
except for patients receiving endocrine therapy. For patients receiving adjuvant
chemotherapy, a blood sample is collected prior to beginning chemotherapy and once during
the final 2 courses of chemotherapy. For patients receiving radiotherapy, a blood sample is
collected during the final 2 weeks of radiotherapy. For patients receiving endocrine
therapy, a blood sample is collected between 2 and 6 months after starting endocrine
therapy. Patients also complete a questionnaire about overall health and concurrent
medications at baseline and during each follow-up visit.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

- Histologically and/or cytologically confirmed stage I-III invasive breast carcinoma
or ductal carcinoma in situ

- Newly diagnosed disease

- Patient must be initiating a new course of treatment for breast carcinoma, including
surgery (mastectomy or lumpectomy with or without nodal evaluation) with or without
any of the following:

- Radiation therapy

- Chemotherapy

- Endocrine therapy

- No known or suspected metastatic disease

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

- Female

- Menopausal status not specified

- No infectious or inflammatory condition, at the discretion of the principal
investigator

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

- More than 6 months since prior surgery

- Fine-needle aspirate or biopsy allowed

- More than 6 months since prior radiotherapy

- More than 6 months since prior chemotherapy

- More than 6 months since prior endocrine therapy

- No neoadjuvant endocrine therapy or chemotherapy

- More than 2 weeks since prior and no concurrent regular use of any of the following:

- Hydroxymethyl glutaryl coenzyme A reductase inhibitor (statin)

- Nonsteroidal anti-inflammatory drug (NSAID)*

- Cyclooxygenase-2 (COX-2) inhibitor

- Aspirin*

- Acetaminophen and opioid use is permitted as needed NOTE: *Use of these products ≤ 2
times per week at standard over-the-counter doses allowed