ONGOING CLINICAL TRIALS AT THE UCSF BREAST CARE CENTER

Soy vs. Tamoxifen to Reduce Breast Density

Breast density is a marker for breast cancer risk. It can be changed with diet. This trial will examine whether soy or tamoxifen can change breast density or the types of cells that are found in the breast ducts. We are also going to draw blood to measure serum hormone levels to heopfully help us to figure out whether some women benefit more than others from soy or tamoxifen. This study is for premenopausal women with dense breasts who are at higher risk for breast cancer. Women who participate will have a 50% chance of being assigned to soy, a 25% chance of being given tamoxifen, or a 25% chance of being given a placebo. The study will go on for six months, after which participants are free to pursue whatever therapy they choose.

We are trying to develop drug combinations for the long-term treatment of premenoausal whomen who are at known high risk of breast cancer, in particular women with a BRCA1 gene mutation. The aimof this study is to reduce breast density, which is a known risk factor for breast cancer. This particular study is a one-year trial. The long-term aim os to achieve substantially reduced breast cancer risk and to enhance the efficacy of premenopausal mammographic screening in these women.

Healthy women who have not menstruated for a least six months are eligible to participate in this study. All participants will receive an herbal formula containing 21 different herbs. The goal of the study is to assess the safety and feasibility of Traditional Chinese Medicine in alleviating hot flashes and other symptoms associaed with menopause.

This study is open to any women who has been diagnosed with early (Stages I-III) breast cancer, but has not yet completed all breast surgery. Micrometastasis (MM)occurs when cancer cells break loose from their original site in the breast and circulate in the bloodstream. This process goes undetected until the cells invade other organs and grow large enough to cause symptoms. Our study will look at three types of tests for early detection of micrometastasis, and will study the relationship between these tests, immune function and recurrence of brest cancer. This study will help us to improve care for future patients, learn more about how to predict whether brest cancer will spread and wether a woman needs chemo or chormonal therapy, and who can avoid further treatment. This study may help us find potential genetic markers for metastasis. If we find a reliable, easy method of detecting circulating cells (MM) in the blood and bone marrow, we can, in the future "tailor therapy" using MM to follow response to therapy. The study has been designed to make it easy to participate. At the time of your surgery, a blood and bone marrow sample is taken while you are under anesthesia.Therefore, the procedure is painless and adds only a few minutes to your surgery.

This is a very special study being done at four institutions around the country, including UCSF. There are many types of breast cancer, and they respond differently to chemotherapy treatment. It may be possibleto learn more about each cancer by studying the changes in core biopsies and MRI images during chemotherapy. Our goal is to predict whether the tumors will shrink enough after chemotherapy so that further treatment and surgery will become unnecessary. The information gained from this trial will help us learn how to tailor treatment, so each person will benefit most and not have to go through unnecessary treatments which do not affect their form of breast cancer. If you are starting with chemotherapy before surgery, you can participate in this study.

This study will use a formula of 21 Chinese herbs to see if they alleviate the side effects of chemotherapy. Though many of these herbs are widely available, this particular formula has been created specifically for this study and has received an Investigational New Drug license from the FDA. This study is randomized; patients have an equal chance of receiving the herbal therapy formula or a placebo. This is our only way to establish a clear effect. However, all patients will continue to have access to regular supportive measures (including standar medications) for side-effects of chemotherapy throughout the trial. Participants will begin taking the herbal formula or placebo two weeks before their first chemotherapy treatments, and will take it each day for a six-month period. Throughout the trial patientsí progress and the side effects of chemotherapy and herbal therapy will be followed closely by the Breast Care Centerís research team, which includes a medical onocologist, epidemiologist, and licensed herbal/acupuncturist. The examinations by the Traditional Chinese Medicine practitioner, herbal formula, and any laboratory work needed specifically for the study will be provided free of charge. This trial is the first in the United States to investigate the use of herbal therpy for breast cancer and is one of several clinical trials on alternative breast cancer therapies currently being conducted at the Breast Care Center.

Next month: clinical trials available for the metastatic patient.

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