Early detection of breast cancer currently depends on mammography and a physical examination. Although mammography is the best screening examination, it rarely detects cancer until it has been present (microscopically) for eight to ten years. Ultrasound and magnetic resonance imaging (MRI) are helpful in specific circumstances, but some cancers are invisible on all of these tests. We need a more sensitive test that can detect breast cancer while it is still microscopic.

Approximately 500,000 breast biopsies are performed each year in the United States, and 80 percent of these are benign. Several hundred thousand women might be spared breast biopsies if a more specific (more reliable) diagnostic test existed.

What we need is a blood test for a biomarker (a molecular change associated with early stage breast cancer). Such a test would substantially improve our ability to diagnose early stage breast cancer.

• What is the purpose of this study?
• What are the benefits of taking part in this study?
• What will I be asked to do?
• Does the study have any risks?
• How long will I be in the study?
• What if I don't want to take part?
• How can I learn more?

We are collecting blood and tissue from patients with breast cancer and patients with benign (non-cancer) breast abnormalities. Studies will be conducted to help scientists understand the biology of breast cancer, identify new ways to diagnose breast cancer and develop new treatments for breast cancer. The investigators hope to develop a simple blood test, based on a biomarker that could be used in conjunction with mammography to detect breast cancer early in the disease process.

To develop an effective biomarker, we have assembled a team of experts, including doctors, scientists and nurses at Cedars-Sinai Medical Center, and they will be collaborating with researchers at the Fred Hutchinson Cancer Research Center in Seattle and researchers at other sites. This multi-institutional collaborative effort allows researchers in different parts of the country to work together toward a common goal.

Researchers will study samples of blood and tissue donated by women undergoing breast surgery. We plan to include women with a wide range of diagnoses (benign and malignant) to assure that the test developed is sensitive to all disease types. If you are schedule to have breast surgery, we welcome your participation regardless of the reason for your surgery.

The study of blood and tissue samples may result in new tests or treatments one day, or may help to prevent or cure breast cancer. Scientific knowledge often advances slowly, but it may greatly benefit future generations.

If you take part in this study, you will be asked to:

• Give a blood sample
• Complete two questionnaires
• Allow us to review your medical records
• Allow us to study breast tissue removed during your surgery that is not needed by your pathologist

We do not anticipate any significant risks. There may be discomfort or bruising from the blood test. Questionnaires make some people anxious. Your surgery will not be affected.

This clinical trial is limited to women at increased risk for developing breast cancer. If you are interested in learning more, please contact:

Research studies include only people who choose to participate. Remember that your participation is completely voluntary - you are free to decline to participate. Your decision will not affect your medical care.

This clinical trial is limited to women at increased risk for developing breast cancer. If you are interested in learning more, please contact:

If you are a healthcare professional and would like to review the protocol and approval information, please click here.