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

NCT ID: NCT00373191

Last Updated: 2015-10-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2013-12-31

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.

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

chemotherapy

N/A- not dictated by study

Intervention Type: DRUG

endocrine therapy

N/A- not dictated by study

Intervention Type: DRUG

DNA methylation analysis

laboratory analysis

Intervention Type: GENETIC

protein analysis

laboratory analysis

Intervention Type: GENETIC

laboratory biomarker analysis

laboratory analysis

Intervention Type: OTHER

questionnaire administration

questionnaire

Intervention Type: OTHER

adjuvant therapy

N/A- not dictated by study

Intervention Type: PROCEDURE

conventional surgery

N/A- not dictated by study

Intervention Type: PROCEDURE

radiation therapy

N/A- not dictated by study

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vered Stearns, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JHOC-J0575

Identifier Type: OTHER

Identifier Source: secondary_id

JHOC-SKCCC-J0575

Identifier Type: OTHER

Identifier Source: secondary_id

J0575 CDR0000485360

Identifier Type: -

Identifier Source: org_study_id