For more information, call Sandra White at 706/821-2944.
Augusta Oncology Associates Seeks Participants
for Metastatic Breast Cancer Study
AUGUSTA, GA. (Sept. 25, 2009) Augusta Oncology Associates is one of approximately 11 sites within the Accelerated Community Oncology Research Network, Inc. that has been chosen to participate in a research study that will evaluate investigational treatment options for women diagnosed with metastatic breast cancer. About 420 total research participants will take part in this study. Of the total number, up to 100 are expected to participate at ACORN sites. Subjects will be randomized (similar to flipping a coin) to one of two groups that compare different courses of treatment. Both groups will receive a combination of gemcitabine and carboplatin, standard chemotherapy drugs that have already been approved by the United States Food and Drug Administration (FDA) for breast cancer. One of the groups will also receive the study drug, or investigational agent, along with the standard chemotherapy drugs. The investigational agent has not been approved by the FDA. It is a man-made drug, classified as a PARP inhibitor, which is designed to interfere with DNA replication. By interfering with DNA replication, the drug may halt, and potentially reverse, tumor growth.
The purpose of this study is to find out how well the investigational agent works in combination with both gemcitabine and carboplatin as a treatment for metastatic breast cancer. The study will also look at what effects (good and bad) the combination of drugs has on those who receive it. Women participating in the study must have metastatic breast cancer and be 18 years of age or older. Additionally, subjects must not be pregnant and must agree to use adequate contraception, as medically appropriate, before and during the study. Subjects must be willing and able to sign a written informed consent. They must also meet other specific requirements defined by the study.
The subject will not be charged for the investigational agent, or any visits or procedures strictly for the purpose of the study. Gemcitabine and carboplatin, along with normal standard of care visits or procedures, will be billed to the subject or subject’s insurance. Standard of care means that the visits or procedures will occur whether or not the subject participates in the study. The study will consist of a screening period, a treatment period, and a follow-up period. Subjects will not be paid.
For further information or to express interest in this research study, please call Sandra White, RN, OCN, CCRC of Augusta Oncology Associates at 706/821-2944. Dr. Mark R. Keaton of Augusta Oncology will direct the research study which is being made available to select oncology practices through the Accelerated Community Oncology Research Network, Inc.