1. BREAST CARE CENTER INVESTIGATOR RESEARCH
(developed by BCC Research)
There are a host of basic science research initiatives in the development phase as part of the Breast Oncology Program of the Cancer Center. These are the studies that will drive the new changes that we bring to patients in the next 5-10 years and that we expect will have an important impact on breast cancer treatment in the future. These include studies to dissect the genetic anatomy of the cancer cells; determine how the host fights or enables tumor progression; evaluate DNA repair, and many others. Studies of breast cancer trends in diagnosis and treatment in the population (Epidemiology) are also important for creating ideas for change.

The following is a list of investigator research and trials currently conducted by our research team:

Investigator Basic Science and Clinical Research

I. Vaccines: Training the body to use the immune system to fight cancer progression based on tumor markers
A. Agents being studied now
1. Her-2/neu
2. C2TA
B. Stage of cancer where we will begin testing
1. DCIS
2. Stage IV

II. Novel Therapeutics based on Immunoliposome technology
A. Introduction of anti-body targeted chemotherapeutic agents
1. Adriamycin filled liposomes with Anti-Her-2/neu antibodies
B. Development of imaging agents that switch hit as therapeutic agents (antibody directed liposome packages that can be filled with an MRI imaging agent, Gadolinium, or a chemotherapeutic agent, or gene therapy)
1. Antibodies to angiogenic markers (Flk-1)
2. Antibodies to Her-2 (Stage III, IV or DCIS)

III. Development of Tools to Determine the Clinical Efficacy of New Therapeutics (all are being tested in clinical trials at the UCSF Breast Care Center)
A. Immune function studies
B. MRI imaging

IV. Micrometastasis Monitoring
Looking in the blood and bone marrow and sentinel lymph nodes to identify circulating tumor cells. This data will help us to design better and more tailored therapies and to monitor the effectiveness of therapy.

Development of MRI Imaging to Predict the Biologic Behavior of Tumors
A. Contrast Signal Enhancement Ratio as a means to view angiogensis (tumor vessel density)
B. Pattern and Density of contrast signal to better understand tumor behavior

VI. Prevention Studies for Women at High Risk for Breast Cancer
A. Testing and developing markers to predict which prevention strategies will work
1. Breast Density, Nipple Aspirate Fluids and cytology, DNA repair
B. Pilot clinical study for large Phase III trial comparing placebo, Tamoxifen, Soy

VII. Stage III Breast Cancer
Novel Approaches for women with locally advanced disease using MRI imaging to stratify care.

VIII. Neoadjuvant Chemotherapy
Pioneering new ways to treat women with locally advanced disease by treating first with chemotherapy, using MRI to monitor response to therapy, and to find alternative new treatments for those who do not show signs of response

IX. Risk of Recurrence and Response to Therapy: Micrometastasis
Finding the best way to identify cancer cells that are in the blood stream or the bone marrow and using this as a way to make treatment decisions and monitor response to therapy in the future

X. Complementary Herbal Medicines
We have a unique program where we are studying the impact of herbs, and acupuncture, as it is integrated into standard treatments and a registry for those on herbal medicines alone.

XI. Personal Support and Life Style trials
We are studying the impact of programs to help make life changes in response to a diagnosis of breast cancer, based on an approach to the whole person and finding ways to integrate theses approaches into the routine of care.

XII. Impact of Genetic Testing
When new technology is introduced, how is it best to use it in the clinical setting? Genetic testing and counseling enables us to use important new information about the predisposition to cancer in families with a strong history of cancer. It is important for us to learn how people adjust to information about inherited risk.

2. INFORMATION MANAGEMENT AND COLLABORATIVE DECISION MAKING.

All of us, patients and providers alike, are frustrated with our inability to more accurately predict the value and risks of the standard interventions for breast cancer. For every newly developed test we must question how it can be appropriately applied to each person. For each treatment we must seriously consider their side effects and research ways in which each treatment can be improved. We know that people want information tailored to their situation. This means that we must ask many questions and store all the information in a way that we can learn from every person who comes to see us. It also means that we must collaborate with other groups to gather similar information. It will take time to be able to provide information to patients that is very specific to their situation, but we believe it is quite possible.

The way in which we currently gather information does not enable us to respond immediately to individual patients' concerns. But we are developing a demonstration project to prove that it can be done and to do it! This exciting project is to automate the collection of everyday information at the Carol Franc Buck Breast Care Center. Getting support for the complicated tasks that are carried out everyday would help everyone from the front desk staff to our physicians and researchers. Working on putting all of the pieces together from research to clinical care should help us to improve care in a shorter period of time and more rapidly get meaningful results from research to the people that can benefit. This is an enormous undertaking and we are working in collaboration with the National Cancer Institute (NCI) and other institutions. Hopefully our work can be a model for other centers and will be made available to those who need them.

All of the information we gather has to be filtered and organized in meaningful ways; our goal is to be able to present risks and benefits of the interventions available so that patients so that they can weigh their options and make high quality decisions. We are using and developing tools to help patients and physicians to prepare for their consultations.

3. COMPREHENSIVE SERVICES ENVIRONMENT

The non-medical needs of the person undergoing breast cancer diagnosis and treatment are as important as the medical interventions. Our goal is to take care of the person who comes to see us, not just their disease. The extra support, which is equally important, cannot be sustained in the managed care environment at this time. Having care in a setting that makes people feel comfortable and safe, and free to ask questions, with additional staff to provide counseling is an important part of our work. For this reason, we also need to support our staff, make sure they have educational opportunities and understand the needs of the people they serve.

The needs of the person undergoing diagnostic procedures are different from those of the person who has recurrent cancer. We want to tailor services programs for women who need:

• management of high risk
• assessment of a symptom of breast cancer (a lump or an abnormal mammogram)
• treatment for newly diagnosed cancer
• surveillance, who are beyond treatment
• evaluation and management of recurrent or metastatic cancer
• "second opinion" or a discussion of options and outcomes for breast cancer

• a nutritionist on site;
• a psychologist on staff;
• a clinical trials referral service, especially for women with recurrent cancer;
• educational materials tailored for patients at different stages;
• the ability to provide the personal touch and take the time to answer all questions, especially while we are trying to carry out research to improve future options.