Breast Cancer Clinical Trial
Official title:
Effects of Surgery, Radiation Therapy, Chemotherapy, and Endocrine Therapy on High-Sensitivity C-Reactive Protein in Women With Operable Breast Cancer
RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the
laboratory may help doctors learn more about changes that may occur in DNA and identify
biomarkers related to cancer.
PURPOSE: This laboratory study is looking at the effects 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.
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Observational Model: Cohort, Time Perspective: Prospective
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