Effects of Surgery, Radiation Therapy, Chemotherapy, and Endocrine Therapy on High-Sensitivity C-Reactive Protein in Women With Operable Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
Effects of Surgery, Radiation Therapy, Chemotherapy, and Endocrine Therapy on High-Sensitivity C-Reactive Protein in Women With Operable Breast Cancer
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.
Inclusion Criteria
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Change in high-sensitivity C-reactive protein and gene methylation over time
Outcome Time Frame:
indefinite
Safety Issue:
No
Principal Investigator
Vered Stearns, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
J0575 CDR0000485360
NCT ID:
NCT00373191
Start Date:
May 2006
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- ductal breast carcinoma in situ
- Breast Neoplasms
- Carcinoma in Situ
- Carcinoma, Intraductal, Noninfiltrating
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
