Newswise — The American Cancer Society estimates 183,000 new cases of breast cancer were diagnosed in the United States last year with more than 40,000 deaths. In New Jersey alone there were 6,300 new cases and 1,400 deaths. It is those statistics on which researchers at The Cancer Institute of New Jersey (CINJ) hope to have impact with a newly opened clinical trial, which has global implications. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School.
Along with other cancer centers across the world, CINJ will offer a unique study targeted at patients diagnosed with HER2 positive breast cancer. The HER2 positive gene is believed to help in the reproduction of cancer cells and accounts for up to 25 percent of all breast cancers. It is considered an aggressive form of the disease and is associated with a greater risk for breast cancer recurrence and death.
The standard treatment for HER2 positive breast cancer includes a drug known as trastuzumab. Research has shown that many patients respond well to this treatment; however, some do not, because of a build up of acquired resistance to this particular drug. Investigators aim to find out why that is by examining four different treatment combinations of trastuzumab with that of a drug known as lapatinib, which has not been approved by the Food and Drug Administration as a treatment for early breast cancer.
The study -- known as the ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization) trial -- is sponsored by Glaxo Smith Kline, North Central Cancer Treatment Group, Breast International Group, the National Cancer Institute and the National Cancer Institute of Canada and aims to enroll 8,000 patients worldwide. The collection of data and the way care is given in the study will be exactly the same no matter where patients are participating in the trial.
Deborah Toppmeyer, MD, director of the New Jersey Comprehensive Breast Cancer Center at CINJ and associate professor of medicine at UMDNJ-Robert Wood Johnson Medical School, is the lead researcher for the study at CINJ. She notes, "We have entered into an age of cancer research in which we know that collaboration is key. By being a part of this global initiative, we have an opportunity to help develop a model, by which research in this area of breast cancer will be measured in the future." For one year, selected patients will undergo one of four treatments, which include taking the drugs paclitaxel and trastuzumab through a needle into a vein, taking a lapatinib pill by mouth, or a combination of the two. Patients will have routine blood and/or urine tests, physical exams and other tests during that time. They also will be required to have follow-up visits on a regular basis until they have been in the study for ten years.
Patients at or over the age of 18 with the diagnosis of early stage HER2 positive breast cancer that has been removed by surgery 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 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 provides patients with 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 clinical trials nationwide is fewer than five percent of all adult cancer patients.
About The Cancer Institute of New JerseyThe Cancer Institute of New Jersey (www.cinj.org) is the state's first and only National Cancer Institute-designated Comprehensive Cancer Center, and is dedicated to improving the prevention, detection, treatment and care of patients with cancer. CINJ's physician-scientists engage in translational research, transforming their laboratory discoveries into clinical practice quite literally bringing research to life. The Cancer Institute of New Jersey is a center of excellence of UMDNJ-Robert Wood Johnson Medical School. To support CINJ, please call the Cancer Institute of New Jersey Foundation at 1-888-333-CINJ.
The Cancer Institute of New Jersey Network is comprised of hospitals throughout the state and provides a mechanism to rapidly disseminate important discoveries into the community. Flagship Hospital: Robert Wood Johnson University Hospital. Affiliate Hospitals: Bayshore Community Hospital, Carol G. Simon Cancer Center at Morristown Memorial Hospital, Carol G. Simon Cancer Center at Overlook Hospital, CentraState Healthcare System, Cooper University Hospital*, Jersey Shore University Medical Center, JFK Medical Center, Raritan Bay Medical Center, Robert Wood Johnson University Hospital at Hamilton (CINJ at Hamilton), Saint Peter's University Hospital, Somerset Medical Center, Southern Ocean County Hospital, The University Hospital/UMDNJ-New Jersey Medical School*, and University Medical Center at Princeton. *Academic Affiliate
RSS