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

Breast Cancer Clinical Trial

Official title:

Effects of Surgery, Radiation Therapy, Chemotherapy, and Endocrine Therapy on High-Sensitivity C-Reactive Protein in Women With Operable Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373191
• Other study ID #: J0575 CDR0000485360
• Secondary ID: P30CA006973JHOC-
• Status: Completed
• Phase: N/A
• First received: September 6, 2006
• Last updated: October 9, 2015
• Start date: May 2006
• Est. completion date: December 2013

Study information

• Verified date: October 2015
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2013
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma in Situ

Intervention

Drug:
• chemotherapy
N/A- not dictated by study
• endocrine therapy
N/A- not dictated by study

Genetic:
• DNA methylation analysis
laboratory analysis
• protein analysis
laboratory analysis

Other:
• laboratory biomarker analysis
laboratory analysis
• questionnaire administration
questionnaire

Procedure:
• adjuvant therapy
N/A- not dictated by study
• conventional surgery
N/A- not dictated by study

Radiation:
• radiation therapy
N/A- not dictated by study

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in high-sensitivity C-reactive protein and gene methylation over time		indefinite	No