A Biologic Efficacy Study of Dasatinib, a Multi-Targeted Tyrosine Kinase, in Locally Advanced Triple-Negative Breast Cancer Patients Developing Effective Therapies for Er-Negative Breast Cancer Using Genomics and Proteomics: Project 3
Women who have been recently diagnosed with a type of breast cancer called "triple
negative", and have not yet received any type of treatment (surgery, radiation therapy,
etc.) for breast cancer are among the patient population this study will seek. "Triple
negative" means breast cancer is not estrogen receptor positive (ER+), progesterone receptor
positive (PgR+) or human epidermal growth factor receptor positive (HER2+). Some types of
breast cancers "overexpress" one or more of these receptors. "Overexpress" means that the
cancer cells have too many of these receptors. ER and PgR are hormone receptors that are
located on some types of breast cancer cells. When these receptors are present, the hormones
estrogen and progesterone are able to tell cancer cells to grow and divide.
This kind of breast cancer does not have an over-production (overexpression) of these three
receptors, and that is why we call it "triple-negative" breast cancer.
We are trying to find new and better treatments for women with triple negative breast
cancer. We do not know what causes triple negative breast cancers to grow. Other research
studies have shown that "triple negative" breast cancers overexpress different types of
receptors. These receptors might help the cancer to grow.
We will be testing a drug called dasatinib. Dasatinib is a drug that is made by
Bristol-Myers Squibb. It is sold under the name of Sprycel. It was first used to treat
patients with leukemia, a type of blood cancer.
Dasatinib interferes with the growth of some cancers. Dasatinib attaches to the cancer cell
and slows down or stops the cancer cell from growing. It is approved by the Food and Drug
Administration (FDA), but not for the kind of cancer that you have been diagnosed with.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The clinical response was assessed using RECIST and based on the changes in the longest diameter of the target lesion measured. Complete Response (CR), Disappearance of the target lesion; Partial Response (PR), >=30% decrease in the diameter of target lesion compared to baseline; Progressive disease (PD), >= 20% increase in the diameter of target lession, taking as reference the smallest diameter recorded since the baseline measurement or the appearance of new lesion; Stable disease (SD), neither sufficient shrinkage as PR or sufficient increase as PD.
Assessment at pre-surgery or 3 to 4 weeks of treatment.
Mothaffar Rimawi, MD
Baylor College of Medicine
United States: Food and Drug Administration
|Baylor College of Medicine, Lester and Sue Smith Breast Center||Houston, Texas 77030|