Study study type PathologyT1T0Patientssample sizesROB Results

la/mBC - HR positive - (neo)adjuvant (NA) breast cancer - HR positive la/mBC - HR positive la/mBC - HR positive - (neo)adjuvant (NA)

versus letrozole
alpelisib plus letrozole
NEO-ORB (wild type cohort), 2019
  NCT01923168
RCTla/mBC - HR positive - (neo)adjuvant (NA)alpelisib plus letrozoleletrozolePostmenopausal women with locally confirmed, HR , HER2−, T1c-T3 operable breast cancer with known PIK3CA mutation status, who had not previously received treatment with local or systemic therapy and were considered eligible for neoadjuvant endocrine therapy were included in this study.131 / 126NA
inconclusive
  • inconclusive 11 % increase in objective responses (ORR) (PE)
  • inconclusive 68 % increase in pCR (PE)
NEO-ORB (mutant cohort), 2019
  NCT01923168
RCTla/mBC - HR positive - (neo)adjuvant (NA)alpelisib plus letrozoleletrozolePostmenopausal women with locally confirmed, HR , HER2−, T1c-T3 operable breast cancer with known PIK3CA mutation status, who had not previously received treatment with local or systemic therapy and were considered eligible for neoadjuvant endocrine therapy were included in this study.-/-NA
inconclusive
  • inconclusive 6 % decrease in objective responses (ORR) (PE)
  • inconclusive 45 % decrease in pCR (PE)