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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
This study is ongoing, but not recruiting participants.
First Received: September 6, 2006   Last Updated: February 26, 2009   History of Changes
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00373191
  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
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:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Surgery
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Change in high-sensitivity C-reactive protein and gene methylation over time

Estimated Enrollment: 30
Study Start Date: May 2006
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
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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000485360, JHOC-J0575, JHOC-SKCCC-J0575
Study First Received: September 6, 2006
Last Updated: February 26, 2009
ClinicalTrials.gov Identifier: NCT00373191     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Skin Diseases
Carcinoma in Situ
Breast Neoplasms
 Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on February 08, 2010



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