OREANDA-NEWS. US Oncology Research, one of the nation's largest research networks specializing in Phase I through IV oncology clinical trials, announced today it is collaborating with BioMarin Pharmaceutical Inc. to offer a groundbreaking Phase III study to investigate the use of BMN 673, a PARP inhibitor, in metastatic breast cancer patients who test positive for BRCA1 or BRCA2 gene mutations. The study will investigate the effectiveness and safety of BMN 673, adding to the promising data currently being analyzed from ongoing Phase I and II studies of the drug. Thirteen US Oncology Research affiliated practices with 56 locations will participate in the study.

"We are excited to collaborate with BioMarin on this important study that can lend more insight into the potential of  PARP inhibitor BMN 673 in a metastatic breast cancer setting," said Joanne L. Blum, M.D., medical oncologist and director, Hereditary Cancer Risk Program, Texas Oncology-Baylor Charles A. Sammons Cancer Center and a principle investigator for the study. "This is an opportunity for patients who have a BRCA1 or BRCA2 gene mutation with metastatic breast cancer to receive an investigational PARP inhibitor to see if it will help control the metastatic disease compared to standard chemotherapy. Eligible patients have the possibility of receiving a promising novel therapy not available elsewhere while participating in a world-class study that may change patients' lives in the future," she noted.

According to the National Cancer institute (NCI), the strongest known predictive risk factor for breast cancer is a positive family history for the disease. Hereditary breast cancer, which can occur generation after generation in some "cancer families," can often be explained by specific mutations in the BRCA1 or BRCA2 genes that belong to a gene class known as tumor suppressors. Women who have a mutation in one of these genes have a greatly increased risk of developing breast and/or ovarian cancer during their lifetimes, and men with these mutations also face an increased risk of breast cancer.

During the past decade, great strides have been made in understanding genetics and its link to various cancers. Several years ago researchers concluded poly ADP-ribose polymerases (PARPs) play a critical role in certain pathways that repair DNA damage, and several recent studies have been investigating inhibiting the activity of PARPs in tumor cells as a therapeutic approach to cancer, including PARP inhibition in BRCA-mutated breast cancer.    

"We are thrilled to collaborate with US Oncology Research and leverage their vast network and clinical expertise in the execution of BioMarin's Phase III trial in patients with metastatic breast cancer with gBRCA mutations," said Hank Fuchs, M.D., chief medical officer of BioMarin.  "We look forward to conducting a world-class study in collaboration with some of the finest clinical investigators to evaluate the safety and efficacy of BMN 673 in this setting."

A Phase III, open-label, randomized, parallel, 2-arm, multi-center study of BMN 673 versus physician's choice in germline BRCA mutation subjects with locally advanced and/or metastatic breast cancer, who have received no more than 2 prior chemotherapy regimens for metastatic disease will investigate the drug's effectiveness, evaluate its safety, and compare it to commonly used treatments. The trial is currently screening patients for enrollment.

"Thanks to the exemplary performance of our Research Regulatory Team led on this project by Regulatory Affairs Specialist Jessica Stabler, we were able to get this study up and running in just eight weeks," explained Lauren Steckel, B.S., project manager of Research Operations for US Oncology Research who was in charge of this project. "With a staff that is deeply committed to our mission and our large affiliated network of research sites already equipped to handle complex trials, we can open studies at a rapid pace, especially for rare patient populations like this one. It is very rewarding to play a role in bringing these potentially life changing agents to this very special group of patients as soon as possible," she noted.

"We are committed to collaborating with others in the cancer community to help develop promising new treatments for patients battling these rare genetic cancers," said Stephen Jones, M.D., medical director for US Oncology Research and associate chair of its Breast Committee. "With our large network of affiliated community-based cancer centers, we are uniquely positioned to rapidly identify and enroll eligible participants in these vital studies that may eventually improve outcomes and quality of life for these rare patient populations that are battling these difficult diseases," he concluded.