Efficacy Study of Dasatinib in Locally Advanced Triple-Negative Breast Cancer Patients
We want to learn if dasatinib will make triple negative breast cancers smaller. We also hope that we can learn more about what makes triple negative breast cancers grow. We believe this information will help us to predict which patients will benefit from taking this drug or other drugs like it.
This study is a "neoadjuvant study", which means that it is only open to women who have not had any treatment for their breast cancer. Neoadjuvant studies allow the study doctor to look at how the cells in your cancer change after taking the study medication. This will help us to understand whether or not dasatinib is an effective treatment for breast cancer. It will also help us to learn more about triple negative breast cancer and how to treat it.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Clinical Efficacy [ Time Frame: Assessment at pre-surgery or 3 to 4 weeks of treatment. ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2008|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: All subjects take open label Dasatinib
Dasatinib / Sprycel 100 mg
pill form, 100 mg daily
Other Name: Sprycel
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817531
|United States, Texas|
|Baylor College of Medicine, Lester and Sue Smith Breast Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Mothaffar Rimawi, MD||Baylor College of Medicine|