100% Recruitment Achieved of LINGain sub-study!
We are pleased to announce that LINGain sub-study “Prospective evaluation of predictive/prognostic immunogenicity biomarkers for target therapy in HER2-positive early breast cancer within the PHERGain clinical study” has achieved 100% of recruitment!
The primary objective of the LINGain project is to analyze the variation of peripheral γδ T cells in blood samples from patients with HER2-positive early breast cancer in neoadjuvant treatment with trastuzumab and pertuzumab (± endocrine therapy) at 6 weeks after the start of treatment respect to the baseline. This is an exploratory sub-study with a biological primary endpoint.
10 Spanish sites have participated and a total of 46 patients have been recruited since January 2018.
It’s been a long journey with many difficulties as the time elapsing between blood collection and centrifugation was critical (it was strongly recommended to process the samples within 6h to guarantee its quality). But the perseverance and effort of all the stakeholders have been the main key to success.
At this time, the recruitment is closed, and all the patient’s blood samples have been analyzed by the Laboratorio de Hematología of the Hospital Arnau de Vilanova de València and the Centro de Diagnóstico Biomédico of the Hospital Clínic of Barcelona. The study data is entered into the database. From now on, we will focus on the analysis of the results with an expected database lock by the beginning of April 2019. The data is being cleaned and has been SDVed and reviewed. In the meanwhile, the data management works closely with the statistic team, to run listings and tables. Our commitment is to obtain the results of the primary objective in the closely near future.
The final sub-study report will be ready by the end of this year, after the interim analysis of the PHERGain study, as the secondary objectives are related to the clinical response.
We hope to accomplish this sub-study’s goal demonstrating the predictive/prognostic impact of γδ T cells in HER2-positive breast cancer in the neoadjuvant setting, since γδ T cells may help to guide clinicians in future therapy decisions.
Thank you very much to all of the site teams for their participation and implication in the sub-study. In particular, we would like to thank both central laboratories for their excellent work.