The Holy Cross Hospital cancer research program announces that it has a clinical trial that provides BRCA testing at no charge for women and men with a certain type of breast cancer. The trial is called the Brocade 3 Study. For BRCA-positive patients the clinical trial involves an investigational medication given along with standard of care treatment.
The study is being conducted by Dr. Leonard Seigel, MD at the Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital. For more information contact the study nurse, Eileen Georgi at 954-267-7748.
The following information was taken from: www.brocade3study.com
About the Study
The Brocade 3 Study is a breast cancer research study that evaluates an investigational drug combination in subjects with HER2- metastatic or locally advanced BRCA-associated breast cancer for which local therapy (surgery or radiation) is not appropriate. If you are unsure if your breast cancer is BRCA-associated, genetic testing might be available. This phase III clinical research study is evaluating the safety and effectiveness of the study medication in combination with Carboplatin and Paclitaxel compared to the combination of Carboplatin and Paclitaxel without the study medication.
Approximately 270 men and women will participate in this study worldwide.
Study volunteers must meet the following criteria:
•Be 18 years of age or older
•Have metastatic breast cancer or locally advanced breast cancer for which local therapy (surgery or radiation) is not appropriate
•Have a BRCA1 or BRCA2 mutation
•Not be pregnant or breastfeeding
•Must be HER2-negative
•Other criteria apply
About Breast Cancer
•Breast cancer is an uncontrolled growth of breast cells.
•Breast cancer is diagnosed in over 1.3 million women worldwide each year and is the leading cause of cancer-related death in women.
•In the United States (US) and Europe, breast cancer is the most common cancer in women, with over 180,000 new cases in the US and 332,000 new cases in the countries of the European Union (EU-27) in 2008.
Breast Cancer Genes:
•There are many genetic factors associated with breast cancer. One of these genetic characteristics includes mutations or alterations in the breast cancer susceptibility genes, BRCA1 and BRCA2.
•BRCA is known as the breast cancer gene. This gene produces tumor suppressor proteins that help repair damaged DNA and is the only known cause of hereditary breast cancer.
•Hereditary BRCA1 and BRCA2 mutations account for around 60% of all inherited breast cancer.
•Hereditary breast cancer accounts for approximately 5% of breast cancer cases, usually occurring before age 50 years.
•Advancing age is the strongest individually identified risk factor for breast cancer, but family history provides one of the strongest clues to the possibility of hereditary breast cancer.
PARP and PARP Inhibitors:
•The investigational medication veliparib is a PARP-inhibitor that is designed to increase sensitivity of tumor cells to DNA-damaging agents. It is being used in combination with paclitaxel and carboplatin in patients with HER2-negative metastatic or locally advanced unresectable BRCA-associated breast cancer.