The ALTTO and NeoALTTO trials – together involving more than 8,000 patients and establishing a huge prospective collection of biological materials for translational research – are a testimony to the strength and richness in terms of scientific expertise, creativity, and flexibility of BIG’s network of research groups to conduct complex international clinical studies. They were coordinated by BIG, the Institut Jules Bordet – Clinical Trials Support Unit, Frontier Science Scotland, and SOLTI in collaboration with GSK and Novartis.
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ALTTO is considered to be the largest-ever adjuvant clinical trial in HER2-positive breast cancer, comparing single adjuvant trastuzumab therapy to dual HER2-targeted treatment (trastuzumab plus lapatinib).
Developed in parallel, NeoALTTO’s objective was to evaluate the benefit of dual HER2-targeted therapy, compared to a single anti-HER2 drug (either trastuzumab or lapatinib alone) given before cancer therapy. The results showed a near doubling of the pathologic complete response rate (pCR) with the dual HER2-targeted therapy rather than the single agent alone.
These results were considered promising for ALTTO and the adjuvant setting. However, the 2014 ALTTO findings did not confirm the predicted benefit of using both anti-HER2 therapies (trastuzumab plus lapatinib).
Despite its unexpected results, the ALTTO trial can be considered to be a landmark study. Not only did this large collaboration trial answer important questions about the adjuvant treatment of women with HER2-positive breast cancer – namely, the findings confirmed that the standard adjuvant treatment for early stage HER2-positive breast cancer should remain trastuzumab in combination with chemotherapy – but the data and samples collected are very valuable for the conduct of promising translational research.