A new milestone of PHERGain study-Chemotherapy-free trastuzumab and pertuzumab in HER2-positive breast cancer: FDG-PET response-adapted strategy-has been achieved.
The last patient recruited in the PHERGain study has completed surgery, so the study has reached another important milestone – Last Patient Last Visit for Interim Analysis – 100% surgery!
The first co-primary analysis, occurring after last patient’s surgery, is to evaluate the rate of pCR (pathological complete response) as defined by the absence of invasive disease in the breast and axilla (ypT0/isN0) at the time of surgery achieved with the combination of trastuzumab and pertuzumab (± endocrine therapy) as exclusive neoadjuvant treatment in PET responders patients (cohort B/PET responders) [PET/CT positive predictive value (PPV) for a pCR among patients who are PET responders].
To guarantee a high-quality of the study data and results for this first co-primary analysis, the data is being cleaned and has been SDVed and reviewed and we expect the database lock by the end of November.
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 Interim Analysis for ASCO 2020.
We believe the results derived from this first co-primary analysis will be highly positive and this will help justify the investigation of this strategy in further clinical trials. Moreover, this will bring an enormous benefit for many breast cancer patients worldwide, who can achieve pCR without the need of chemotherapy.
We couldn’t get to this stage without the continuous support of all the site teams in the PHERGain study, and especially all the study coordinators and data entries who helped us achieve a clean database for the Interim analysis. Thank you all for your collaboration!
Author: Marta Martínez de Falcón