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Welcome back. We hope the first edition of the Clinical Research Connection was of value to you; and that each subsequent issue includes information you can use; as well as an opportunity to increase communication and interaction.
Providing a vehicle for our affiliate members to share news, ideas and suggestions, reports on ECOG meetings and programs, and call attention to high-priority trials, are some of the goals for this newsletter. What else would you like to see? What kind of articles would facilitate our joint efforts? Please send Vera Jackson your feedback and suggestions at affiliates@northwestern.edu.
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New Study of Targeted Therapies for Breast Cancer is Model for Global Clinical Trials
Two targeted medications designed to treat an aggressive form of breast cancer are being tested in a new study involving 8,000 participants in 50 countries across six continents—a clinical trial that investigators hope will provide a new model for global cancer research. This trial, dubbed ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization study), is one of the first global initiatives in which two large, academic breast cancer research networks covering different parts of the world have jointly developed a study in which all care and data collection are standardized, regardless of where patients are treated. The networks are the Breast International Group (BIG) in Brussels, Belgium and The Breast Cancer Intergroup of North America (TBCI, which consists of six NCI-funded clinical trials based in the United States.
ALTTO is designed to answer the most pressing questions regarding use of two widely used cancer agents--whether one agent is more effective, which agent is safer for patients, and what benefit will be derived by taking the drugs separately, in tandem order, or together. The trial is a randomized, Phase III study, considered a gold standard method for proving drug effectiveness.
The two agents tested in ALTTO are drugs designed to treat HER2-positive tumors, which is a particularly aggressive form of cancer that affects approximately 20 to 25 percent of breast cancer patients. Both agents, trastuzumab (Herceptin) and lapatinib (Tykerb), have already been approved by the U.S. Food and Drug Administration for use for treatment of HER2-positive breast cancer. ALTTO provides the first head-to-head comparison of trastuzumab and lapatinib in the earliest, most treatable stages of cancer. It is also one of the first large-scale studies to evaluate lapatinibs effectiveness in treating early breast cancer.
ALTTO is one of the first trials of its scope in which translational research -- taking science from bench to bedside -- plays a critical role, investigators say. In ALTTO, biological material will be collected from thousands of patients in order to determine a tumor profile that responds best to the drugs -- information that could lead to individualized patient care and, possibly, to development of next generation agents. “The difference between this study and many that came before it is that the collection of biological materials occurs as the trial is being conducted, not as an afterthought. While there are exceptions, not many companies or organizations have been willing to invest in that kind of research before,� said Martine Piccart-Gebhart, MD, PhD, professor of oncology at the Université Libre de Bruxelles, Belgium, and lead investigator for BIG, a network of 41 non-US research groups from around the world. “Now we have the chance to optimize therapy with powerful drugs in order to provide the best treatment possible for each of our patients.�
To date, more than 300 centers around the world have enrolled patients into ALTTO. Full enrollment is expected to involve about 500 centers in the United States and more than 800 centers in Europe and the rest of the world. Mary Cianfrocca, DO, is serving as PI for this study, which is currently being conducted at Northwestern University. ECOG affiliates who are interested in opening the study at their site should contact Vera Jackson at v-jackson2@northwestern.edu or Drashti Desai
at d-desai@northwestern.edu
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