CINJ commences enrollment in three-drug combination trial for breast cancer

Researchers at The Cancer Institute of New Jersey (CINJ) are enrolling patients for a clinical trial, which aims to evaluate a new drug for breast cancer that has spread (metastatic) in combination with two chemotherapy agents called doxorubicin and cyclophosphamide. CINJ is a Center of Excellence of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School.

This trial, sponsored by the National Cancer Institute Cancer Therapy Evaluation Program, is combining the experimental drug ABT-888 -- an agent that targets DNA repair -- with the FDA-approved drugs doxorubicin and cyclophosphamide. ABT-888 is part of a class of drugs known as poly (ADP-ribose) polymerase (PARP) inhibitors. Both doxorubicin and cyclophosphamide kill cancer cells by damaging the materials that makes up one's genes. This material (DNA) allows cancer cells to survive and reproduce. One's body has certain proteins that try to help repair DNA damage. ABT-888 may prevent such repair so that the chemotherapy can kill more cancer cells than if chemotherapy was given alone.

Antoinette R. Tan, MD, MHSc, a medical oncologist at CINJ and associate professor of medicine at UMDNJ-Robert Wood Johnson Medical School, is the lead investigator of the study. "ABT-888 blocks enzymes that repair DNA damage. The addition of this investigational agent affects the DNA repair process and in essence, may help chemotherapy do its job," notes Dr. Tan, who is also the director of CINJ's Phase I and Investigational Therapeutics Program. "Because doxorubicin and cyclophosphamide are used in the treatment of breast cancer, this proposed combination could have implications for treatment of earlier stage breast cancer. Cell lines with BRCA mutations have been shown to be sensitive to PARP inhibitors, so this treatment also could have application for metastatic patients with BRCA mutations."

Before taking part in the trial, interested participants will undergo various examinations including a general physical and routine blood and urine tests. Selected patients will take ABT-888 by mouth and doxorubicin and cyclophosphamide through a vein for a three-week cycle. Participants also will keep a medication diary and continue with standard testing such as blood work and physical exams throughout the trial period. If it is deemed the patient is having a positive response to the drug combination, the patient will have the option to continue with that course of treatment for the remainder of the study, which is expected to take one year to complete.

Those 18 and older who have metastatic breast cancer are eligible to take part in the trial, although other criteria must be met. For more information on how to take part, individuals should call CINJ's Office of Human Research Services at 732-235-8675.

Clinical trials, often called cancer research studies, test new treatments and new ways of using existing treatments for cancer. At CINJ, researchers use these studies to answer questions about how a treatment affects the human body and to make sure it is safe and effective. There are several types of clinical trials that are currently underway at CINJ, including those that diagnose, treat, prevent, and manage symptoms of cancer. Many treatments used today, whether they are drugs or vaccines; ways to do surgery or give radiation therapy; or combinations of treatments, are the results of past clinical trials.

As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center, CINJ offers patients access to treatment options not available at other institutions within the state. CINJ currently enrolls more than 3,000 patients in clinical trials annually, including approximately 17 percent of all new adult cancer patients and approximately 70 percent of all pediatric cancer patients. Enrollment in these studies nationwide is fewer than five percent of all adult cancer patients.