SIGNIFICANT ONGOING CLINICAL TRIALS

Definitive, Late Phase Trials

Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Study

http://www.cancer.gov/clinicaltrials/noteworthy-trials/altto

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), 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. The networks are The Breast Cancer Intergroup of North America (TBCI), based in the United States, and the Breast International Group (BIG) in Brussels, Belgium. TBCI consists of six NCI-funded clinical trials Cooperative Groups.

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, also known as BIG 2-06/N063D (http://www.cancer.gov/clinicaltrials/search/view?cdrid=558836&version=healthprofessional), is a randomized, phase 3 study, which is considered the 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 and lapatinib, have already been approved by the 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 is also one of the first large-scale studies to evaluate lapatinib's 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. In ALTTO, biological material will be collected from thousands of patients 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.