100% Recruitment Achieved of PHERGain study!
We are thrilled to announce that PHERGain study has reached 100% of recruitment!
The goal of this multinational, open-label, randomized phase II clinical trial is to assess the early metabolic effects of neoadjuvant treatment with trastuzumab and pertuzumab, with or without endocrine therapy, on the primary tumor and axillary lymph nodes and their predictive value regarding pathological complete response (pCR). Moreover, this study aims to assess 3-year invasive disease-free survival (iDFS) in these patients using an FDG-PET response-adapted strategy.
56 sites distributed in 7 European countries (Spain, France, Italy, Portugal, Belgium, UK and Germany) have recruited a total of 377 patients since June 2017.
It’s been a long journey until reaching this stage of the study, we may remark that many difficulties were found, particularly in the management of the study screening procedures and timelines. Nonetheless, it is really gratifying to know that so many patients are benefiting from the study treatment.
As we wanted to guarantee a high-quality level of the study data, a centralized pathological assessment of patient’s HER2 tumor status was implemented in the Laboratory of Hospital Ramón y Cajal. Another key study aspect to consider is the central 18F-FDG PET review, for this, we counted with the participation of an image quality control service and three expert reviewers from two teams, one based in Brussels (Institute Jules Bordet) and another based in Barcelona (IEC). Furthermore, all the 18F-FDG PET tests were done in accredited centers of excellence, holding an EARL certificate.
We also had to overcome many adversities that had an impact on the study recruitment, considering the timeframes for the regulatory approvals in several countries were extended more than expected. In addition, the initial estimations on screening failure patient number due to non-measurable disease by 18F-FDG PET were underestimated (15% real number). Nevertheless, we took advantage of this derived information, and we designed a sub-study aiming to explore the clinical, pathological and molecular characteristics of these screening failure patients (the RESPONSE sub-study).
At the moment, the patient study recruitment is closed, and we will now focus on the interim analysis due by September 2019.
We hope that the study outcome will allow researchers to predict and define that set of patients which can achieve pCR without
the need for chemotherapy. This would be an amazing achievement for many breast cancer patients worldwide.
Thank you very much to all of the site teams for their participation and study involvement. In particular, we would like to thank the Hospital Universitario Virgen del Rocío (Dr. Manuel Ruiz Borrego), ICO-Hospitalet (Dra. Agostina Stradella) and Hospital Clínico Universitario de Valencia (Dra. Begoña Bermejo) for their commitment and for being the top recruiters in this study. A special thank to F Hoffmann-La Roche Ltd. for their continuous support during the conduct of the trial.