Clinical trial NCT00373191: 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
Official title: Effects of Surgery, Radiation Therapy, Chemotherapy, and Endocrine Therapy on High-Sensitivity C-Reactive Protein in Women With Operable Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: 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
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-09-07
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed ductal carcinoma in situ or invastive breast cancer.

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.

Eligibility 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

Primary outcomes:
measure: Change in high-sensitivity C-reactive protein and gene methylation over time
timeFrame: indefinite
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Vered Stearns, MD
role: PRINCIPAL_INVESTIGATOR
References: