Interesting commentary on the Phase 1B results, I believed this has been discussed quite some time ago however thought i'd revisit it.
So has it expanded to 34 participants due to another pCR or CR?
This study is currently in a Phase 2 trial in women with HER2 negative locally advanced breast cancer, and five of the patients in the Phase 1b study qualify for assessment of Phase 2 data. The Phase 2 trial will be in 26 patients using a two stage Simons MinMax Design. If at least three pCRs are observed in the first 11 patients, then the Phase 2 trial expands to another 15 patients. For the purposes of this analysis, two pCRs have already been observed in the first five patients.
Pathological Complete Response (or Complete Response) (pCR or CR): meaning complete eradication of cancer from the patient;
Clinicaltrials.gov -
Column 1 Column 2 0 Actual Enrollment : 34 participants
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