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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00373191
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):

Study Description
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 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.

Condition or disease Intervention/treatment
Breast Cancer Drug: chemotherapy Drug: endocrine therapy Genetic: DNA methylation analysis Genetic: protein analysis Other: laboratory biomarker analysis Other: questionnaire administration Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy

Detailed Description:


  • 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.

Study Design

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Surgery, Radiation Therapy, Chemotherapy, and Endocrine Therapy on High-Sensitivity C-Reactive Protein in Women With Operable Breast Cancer
Study Start Date : May 2006
Primary Completion Date : February 2009
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    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
    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

Outcome Measures

Primary Outcome Measures :
  1. Change in high-sensitivity C-reactive protein and gene methylation over time [ Time Frame: indefinite ]

Biospecimen Retention:   Samples With DNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with newly diagnosed ductal carcinoma in situ or invastive breast cancer.


  • 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


  • 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


  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373191

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center
More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00373191     History of Changes
Other Study ID Numbers: J0575 CDR0000485360
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0575 ( Other Identifier: SKCCC )
JHOC-SKCCC-J0575 ( Other Identifier: SKCCC )
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type