| Study | study type
|
Pathology | T1 | T0 | Patients | sample sizes | ROB | Results | deaths (OS) E | progression or deaths (PFS) E | RFS/DFS E | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | RCT | la/mBC - HR positive - (neo)adjuvant (NA) | alpelisib plus letrozole | letrozole | Postmenopausal 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 / 126 | NA | inconclusive | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| NEO-ORB (mutant cohort), 2019 NCT01923168 | RCT | la/mBC - HR positive - (neo)adjuvant (NA) | alpelisib plus letrozole | letrozole | Postmenopausal 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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