Overview

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

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
Female
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborator:
National Cancer Institute (NCI)
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