New study ALTTO. information
Madrid, 2011-September interim analysis planned the data from the study of phase III ALTTO, comparing four arms of adjuvant lapatinib, (Tyverb ®), trastuzumab, or a combination of both (of either sequential or concurrent) in patients with early breast cancer compounds ErbB2 positiveIt has given rise to a change in the development of the study. The independent data monitoring Committee has recommended that three of the arms of the study will continue as planned. However the Committee pointed out that it is unlikely that lapatinib monotherapy arm meets the necessary criteria to show non-inferiority with the arm of trastuzumab in monotherapy with regard to the objective of disease-free survival. According to this finding patients belonging to the treatment with lapatinib monotherapy arm will prevent such treatment and consult your treatment options with your doctor responsible for the study. The recruitment of this study has been completed and the three remaining arms continue as planned.
The use of lapatinib in the adjuvant setting is not approved in any country in the world.
About the ALTTO study
ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization trial;) (NCT00490139) is a study of phase III multicenter, randomized and open he studied adjuvant therapy with lapatinib, trastuzumab, or a combination of both (of either sequential or concurrent) in patients with cancer of early breast ErbB2 positive. Patients were randomized to receive lapatinib, trastuzumab, followed by lapatinib trastuzumab or lapatinib and trastuzumab combination. The main analysis of the study will assess the possible superiority between the arms of the combination and monotherapy with trastuzumab for disease-free survival.
The ALTTO study have randomized more than 8,000 patients in approximately 1,500 research centers distributed in 44 countries. Recruitment of patients began in June 2007 and finished in 2011.
The ALTTO study is led by two relevant academic groups — BIG (Breast International Group) and NCCTG (North Central Cancer Treatment Group) in collaboration with GlaxoSmithKline.
About adjuvant therapy
Adjuvant therapy is the additional treatment after primary treatment and surgical resection in order to reduce the risk of cancer can recur. Such therapy may include chemotherapy, radiotherapy, hormone therapy and/or targeted or biological therapies.
On lapatinib (Tyverb) ®
Lapatinib is approved in the context of metastatic in 107 countries including USA, Europe, Australia, India, Brazil, Russia, Turkey, Korea of the South among others.
In Europe, lapatinib is approved in combination with an aromatase inhibitor (AI) is indicated for the treatment of female posmenopaúsicas with breast cancer with receptor ErbB2 positive and positive Hormone receptors for which chemotherapy is not indicated. Also approved, in combination with capecitabine for the treatment of patients with metastatic disease and receiving positive ErbB2 have been previously treated with antracuclinas, taxanes and trastuzumab.
GSK Oncology
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