 
New Era of Breast Cancer
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The drug being studied is called docetaxel. Researchers will evaluate its role in combination with other breast cancer drugs in use. Docetaxel is used to treat patients for whom the cancer has metastasized, or spread, to other parts of the body. Doctors believe that it will be effective in treating cancer isolated to the breast.
"This is a new standard of care," said Paul J. Petruska, M.D., professor and director of the division of hematology and oncology. "We are directly comparing the old standard of treatment to a new regimen."
In one study for node positive disease, researchers will examine three different options involving docetaxel. First, patients who are lymph node positive but non-metastatic will receive cyclophosphamide and doxorubicin, which are considered the traditional standard of care, followed by docetaxel. The second study group will receive docetaxel and doxorubicin, and a third group will receive all three drugs.
In the second study, doctors are seeking women with 0 to 3 positive (or diseased) lymph nodes. This study will directly compare two options: cyclophosphamide and doxorubicin (the standard care) against doxorubicin and docetaxel.
"The first two studies are going to give us a lot of answers in the adjuvant, non-metastasized setting," Petruska said. "In study one, we want to know if we can give all three drugs and if that is better than doxorubicin and docetaxel alone. We will be looking at not just the effectiveness, but the level of toxicity, too."
A third study will evaluate the role of docetaxel in addition to cyclophosphamide and doxorubicin in women who have breast cancer but have not yet had a mastectomy or lumpectomy. In this population, researchers will have three separate arms to evaluate. First, they will examine cyclophosphamide and doxorubicin followed by surgery (either a lumpectomy or mastectomy). The second arm will look at patients who receive cyclophosphamide, doxorubicin and docetaxel before surgery. The third group will get cyclophosphamide and doxorubicin pre-operatively followed by docetaxel post-operatively.
"The purpose of this third study is simple," Petruska said. "We want to try to reduce the disease so the patient can have a lumpectomy instead of a mastectomy. But more importantly, we hope docetaxel will increase the survival rate in women with breast cancer."
All of these are nationwide studies sponsored by the Southwest Oncology Group, the Eastern Cooperative Oncology Group and the National Surgical Adjuvant Breast and Bowel Project (NSABP).
To learn more details or to volunteer, call Carole Giese in the division of hematology and oncology at the School of Medicine at 577-8854.
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