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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00373191
First received: September 6, 2006
Last updated: March 14, 2014
Last verified: March 2014

September 6, 2006
March 14, 2014
May 2006
February 2009   (final data collection date for primary outcome measure)
Change in high-sensitivity C-reactive protein and gene methylation over time [ Time Frame: indefinite ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00373191 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum

Probability Sample

Patients with newly diagnosed ductal carcinoma in situ or invastive breast cancer.

Breast Cancer
  • Drug: chemotherapy
    N/A- not dictated by study
  • Drug: endocrine therapy
    N/A- not dictated by study
  • Genetic: DNA methylation analysis
    laboratory analysis
  • Genetic: protein analysis
    laboratory analysis
  • Other: laboratory biomarker analysis
    laboratory analysis
  • Other: questionnaire administration
    questionnaire
  • Procedure: adjuvant therapy
    N/A- not dictated by study
  • Procedure: conventional surgery
    N/A- not dictated by study
  • Radiation: radiation therapy
    N/A- not dictated by study
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
December 2013
February 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00373191
J0575 CDR0000485360, P30CA006973, JHOC-J0575, JHOC-SKCCC-J0575
Not Provided
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP