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Going global
March 2008
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BRUSSELS, Belgium—Global cooperation and translational medicine are just two of the trends playing out as part of a new international trial led by the Breast International Group (BIG) in Belgium and The Breast Cancer Intergroup of North America (TBCI), based in the United States. TBCI consists of six clinical trials cooperative groups funded by the National Cancer Institute (NCI) of the National Institutes of Health.

Two targeted medications designed to treat an aggressive form of breast cancer are being tested in this 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.
 
Dubbed ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization study), this trial will be 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.

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, which is 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 percent to 25 percent of breast cancer patients. Both agents, trastuzumab (Herceptin) and lapatinib (Tykerb), have already been approved by the U.S. FDA for use for treatment of HER2-positive breast cancer. ALTTO will provide the first head-to-head comparison of trastuzumab and lapatinib in the earliest, most treatable stages of cancer. It will also be one of the first large-scale studies to evaluate lapatinib's effectiveness in treating early breast cancer.

The trial is unusual in that it has two different designs depending on whether patients with stage I or stage II breast cancer have already been treated with chemotherapy. The study thus will compare four different regimens of targeted therapy administered over a 52-week period. Patients will be randomized to receive either trastuzumab or lapatinib alone, or trastuzumab followed by lapatinib, or the two treatments in combination.

"There have been major im-provements in the management of patients with early breast cancer in the last few years, so this new study builds on this knowledge and sets an example of the new era: good science, good worldwide collaboration," says Dr. Edith Perez, an oncologist in the North Central Cancer Treatment Group (NCCTG) at Mayo Clinic in Jacksonville, Fla., who will lead the study for TBCI. "It may be that using two treatments that work in different ways against HER2-positive breast cancer offers a complementary strategy that is more powerful than either drug alone."

In addition to the global standardization, ALTTO will be 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," says Dr. Martine J. Piccart, professor of oncology at the Université Libre de Bruxelles, Belgium, and lead investigator for BIG, which she founded in 1996. "Now we have the chance to optimize therapy with powerful drugs in order to provide the best treatment possible for each of our patients."

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