Disease Background

Introduction
The IGSP focuses on research to improve breast cancer treatment through better knowledge of tumor biology. Together with the Duke Comprehensive Cancer Center and the Division of Medical Oncology at Duke University Medical Center, the IGSP has created a clinical trials program where new scientific discoveries are part of clinical trials.

Our goal is to give doctors information about the tumor that tells us whether it will respond to a particular chemotherapy treatment. Focusing on tumor biology, the IGSP can match genetic and genomic changes to how a breast tumor behaves. Our initial studies show that treatment response can be predicted by genomic changes in breast cancer tumors. Our hope is that in the future doctors can use genomic information to help them choose the best treatment for an individual patient, leading to personalized (individualized) breast cancer treatment.

We are planning a clinical trial that will determine if genomic information from the tumor can predict the most effective chemotherapy to improve treatment outcomes. The trial will open at Duke in 2008 and is done together with the Duke Comprehensive Cancer Center.

About Breast Cancer
Breast cancer is the second highest cause of cancer deaths in American women. About 211,000 women are diagnosed with breast cancer each year. About 40,000 women die from the disease each year. Eight in 10 women treated for breast cancer receive chemotherapy, or chemotherapy combined with hormonal therapy, as part of their treatment.

Early stage breast cancer is treated with surgery, often followed by chemotherapy, hormonal therapy, or targeted therapy. Chemotherapy can also be given before surgery, and then it is called pre-operative or neoadjuvant therapy. Large-scale studies show that these therapies work well to treat most breast cancer. Unfortunately, these treatments do not work to the same extent for all breast cancers. In most cases, doctors cannot tell ahead of time which therapy will work the best for each patient.

Breast cancer is generally treated using a standard approach that is typically based on results from studies of large groups of patients. Doctors try a combination of treatments based on what they think will work best. This means that when a doctor currently selects a chemotherapy agent to treat a breast cancer tumor, he/she is unable to use detailed information about each tumor to select a treatment plan tailored for each individual patient.

Even though we know tumors vary in their behavior, we have not been able to predict which patients will respond to a type of treatment. Our research hopes to change this. We will look at genomic information from each patient's tumor, and use this information to find which is the most effective chemotherapy for each patient's tumor. In the future, this detailed genomic information about the tumor may result in more effective treatments to attack the tumor.

Genes, Cells, & Cancer
The human body is built from millions of cells. Inside each cell is DNA, the inherited genetic material that programs cell growth and development. DNA is organized into genes. Each gene contains the information for a specific task carried out by the cell. Genes represent the "blueprint" for all processes of the human body. The collection of all our genes is called the genome. Scientists estimate that the human genome contains 20,000 to 25,000 genes. Although each cell contains a full set of genes, not all of the genes are active at the same time. Some genes are turned 'on' and others are turned 'off' at different times. When genes are turned 'on' they are copied into RNA. We can measure the amount of RNA in a group of cells (such as a tumor) to assess which genes are turned 'on' (expressed) or 'off' (not expressed).

It is possible for genes to become damaged or changed over time. Damaged genes can result in cells that no longer act the way they should. For example, the genes that stop a cell from multiplying might become damaged. If a cell is unable to stop multiplying, it will keep on multiplying and may lead to a tumor. There are many changes that can lead to a cell's ability to grow out of control and become a tumor. It is possible that a cell can have changed gene expression (RNA level) that can result in a tumor.