Trial of new combination treatment targeting hormone receptor-positive locally advanced breast cancer

Researchers at The Cancer Institute of New Jersey (CINJ) have opened a clinical trial, which aims to evaluate a new treatment for breast cancer in combination with one that is already approved for other types of cancers.

The new combination is targeted toward treatment of hormone receptor-positive locally advanced cancer (cancer cells that grow and multiply when the estrogen hormone attaches to the hormone receptor) or metastatic breast cancer (cancer that spreads to other parts of the body). CINJ is a center of excellence of UMDNJ-Robert Wood Johnson Medical School.

According to the American Cancer Society, excluding skin cancer, breast cancer is the most frequently diagnosed cancer in women. In 2008, it was estimated that more than 182,000 women were diagnosed with breast cancer in the United States, while more than 40,000 died from the disease. In New Jersey, there were 6,300 new cases with approximately 1,400 deaths. That is why CINJ investigators are testing the effectiveness of the drug sorafenib in combination with letrozole.

Sorafenib is an approved medication by the U.S. Food and Drug Administration (FDA) used to treat certain advanced kidney cancers and liver cancer. It fights the disease by interfering with the ability of cancer cells to grow and divide. There have been studies performed with this drug by itself in patients with metastatic breast cancer, with results showing only a small effect on the tumor.

But according to Antoinette Tan, MD, a medical oncologist at CINJ and assistant professor of medicine at UMNDJ-Robert Wood Johnson Medical School, there is a lot of potential for sorafenib to be combined with letrozole, a drug which blocks enzymes that make the estrogen hormone. Letrozole received FDA approval in 2001 for the treatment of patients with metastatic breast cancer. It has been shown to be more effective than the drug tamoxifen, which is commonly used for treatment, and to have fewer side effects than other medications used in hormonal therapy. Dr. Tan is the lead researcher on the new study.

Selected patients will take letrozole and sorafenib by mouth and keep a pill diary for 28 days. At 12 weeks, patients will undergo tests like a CT scan or MRI, which look at the organs in the body, to check on the combined effect on the tumor. The aforementioned drugs for the study will be supplied by Bayer Pharmaceuticals and Novartis Pharmaceuticals.

Women over age 18, who are post-menopausal and have the diagnosis of hormone receptor-positive locally advanced or metastatic breast cancer are eligible to take part in the trial, although other criteria must be met. The study is part of the CINJ Oncology Group (CINJOG), which is comprised of physicians throughout New Jersey from the CINJ Network of hospitals. For additional information on how to participate, individuals should call 732-235-7251.

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 it is 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 1,000 patients on clinical trials, including approximately 15 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.

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