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Effects of Surgery, Radiation Therapy, Chemotherapy, and Endocrine Therapy on High-Sensitivity C-Reactive Protein in Women With Operable Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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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 HopkinsBaltimore, Maryland  21231-2410