The ALTTO trial is a worldwide study to evaluate the effectiveness of a new therapy, lapatinib (Tykerb®/Tyverb®) in treating early breast cancer following surgery. The trial enrolled patients who have HER2 (ErbB2)-positive breast cancer, which is characterised by too much HER2 (ErbB2) protein in the tumour and a greater risk of the tumour coming back.
Between June 2007 and July 2011, ALTTO recruited 8381 patients, who were treated with lapatinib or trastuzumab (Herceptin®)—alone, in combination, or in sequence (one after the other). Lapatinib is an investigational adjuvant therapy that is given as a tablet. Trastuzumab is currently approved for adjuvant breast cancer therapy in the United States and Europe and is given intravenously.
The ALTTO trial has been conducted at about 1300 sites (hospitals or doctor's offices) in approximately 50 countries around the world. The first patients were enrolled into the trial in June 2007. Patients received study treatment for one year (52 weeks), and will be followed for a total of 10 years. The trial is now closed to enrolment (the last patient was randomised in July 2011).
ALTTO is organised by two prominent academic groups—BIG (Breast International Group) and NCCTG (North Central Cancer Treatment Group), which carry out research to improve the treatment and prevention of cancer. ALTTO is also conducted in collaboration with GlaxoSmithKline.
A companion trial—the Neo-Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (Neo-ALTTO) trial—is evaluating lapatinib as neoadjuvant treatment of breast cancer. Neoadjuvant treatment is given with the goal of shrinking the tumour prior to surgery. Neo-ALTTO is now closed to enrollment.