Status:
COMPLETED
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
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00373191
Start Date
May 1 2006
End Date
December 1 2013
Last Update
October 12 2015
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410