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
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Change in high-sensitivity C-reactive protein and gene methylation over time [ Time Frame: indefinite ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Enrollment: 35
Study Start Date: May 2006
Study Completion Date: December 2013
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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
    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
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373191

Locations
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
Investigators
Principal Investigator: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00373191     History of Changes
Other Study ID Numbers: J0575 CDR0000485360, P30CA006973, JHOC-J0575, JHOC-SKCCC-J0575
Study First Received: September 6, 2006
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

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
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on April 17, 2014