Phase III EMBRACA Clinical Trial Currently Enrolling Hispanic Individuals – Particularly of Mexican and Puerto Rican Descent — due to Higher Prevalence of BRCA Mutation
What: Breast cancer is the most commonly diagnosed cancer in Hispanic women and the continued leading cause of cancer death. The EMBRACA clinical trial is studying the safety and efficacy of an investigational drug, talazoparib, as a potential treatment for patients with advanced breast cancer who carry a BRCA mutation, and is currently enrolling Hispanic women, particularly of Mexican and Puerto Rican descent, due to higher prevalence of a BRCA mutation.
BRCA gene mutations may be hereditary and their presence indicates a higher risk of developing breast cancer, among other types of cancer. BRCA1 and BRCA2 are human genes that are involved in DNA repair. When either of these genes are altered, DNA repair may not occur correctly, making tumors more likely to appear.
Patients eligible for the EMBRACA clinical trial must have locally advanced and/or metastatic breast cancer with a deleterious germline BRCA1 or BRCA2 mutation, received no more than three prior cytotoxic chemotherapy regimens in advanced settings, and are deemed appropriate for single-agent therapy. Patients may have either triple negative or hormone receptor positive breast cancer.
Where: The EMBRACA clinical trial is currently being conducted at several sites in the United States and worldwide. For a full list of participating locations in the Los Angeles area and for information on enrollment and eligibility visit www.embracastudy.com.
Why: BRCA mutations account for more than 50% of hereditary breast cancers, and up to 65% of women who genetically inherit a deleterious BRCA mutation will develop breast cancer by the age of 70. Understanding the genetic basis for certain types of breast cancer, such as being positive for the BRCA1 and BRCA2 mutation, can be helpful. For example, it may assist in the treatment decision-making process or in finding out about eligibility for clinical research that provides access to therapies that are being studied to obtain regulatory approval, but that are not currently available. Although there is no guarantee patients will experience a clinical benefit, each participant will be helping understand this devastating disease and how to treat it with new drugs in development. All trial-related medication and care, including genetic testing for BRCA mutations, are provided at no cost.
**Medivation, Inc. executives are available for media inquiries upon request**
About Medivation, Inc.: Medivation, Inc. is a biopharmaceutical company seeking to transform the lives of patients by developing and delivering medically innovative therapies to treat serious diseases for which treatment options are limited.
The EMBRACA clinical trial is sponsored by Medivation, Inc. Its investigational drug talazoparib is a type of anticancer drug called a PARP (poly ADP ribose polymerase) inhibitor, which currently is being investigated in patients with BRCA-mutated cancers. PARP is important for normal DNA repair, a process necessary for continued tumor growth. The efficacy and safety of talazoparib has not been established for any use.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.