This last September (2019), the 23rd patient in the Phenomenal Study was included in the trial. We have reached a new milestone, the Stage I have recruited 23 evaluable patients. An interim analysis has been performed thoroughly.
The Steering Committee meeting of the Stage I was held on October 29th, and after reviewing the efficacy and safety raw data, it was unanimously concluded to open the Stage II of the Phenomenal Trial. The results showed 2 responders among these 23 patients and a little benefit for the subjects with HER2-negative breast cancer treated with nal-IRI for progressing brain metastases.
We are thrilled to announce that the recruitment for the Stage II of the Phenomenal Study has been opened since this past November.
On behalf of MedSIR, we would like to thank all the study teams for their commitment and interest in the study. We encourage them to continue identifying the 33 patients fitted for recruitment, subjects of the Stage II within the next 18 months. We would also like to be actively able to benefit patients with HER2-negative breast cancer with progressing brain metastases with nal-IRI treatment.
Author: Marta Malo.