| Study | study type
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Pathology | T1 | T0 | Patients | sample sizes | ROB | Results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 (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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| 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 |
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la/mBC - HR-positive - 2nd line (L2) breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 2nd line (L2) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus fulvestrant | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
alpelisib plus fulvestrant | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SOLAR-1 (patients without PIK3CA mutant status), 2019 NCT02437318 | RCT | la/mBC - HR-positive - 2nd line (L2) | alpelisib plus fulvestrant | placebo plus fulvestrant | Patients were men and postmenauposal women with locally advanced confirmed HR positive, HER2 negative breast cancer / Patient has recurrence or progression of disease during or after AI therapy | 115 / 116 | low | inconclusive |
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| SOLAR-1 (patients with PIK3CA mutant status), 2019 NCT02437318 | RCT | la/mBC - HR-positive - 2nd line (L2) | alpelisib plus fulvestrant | placebo plus fulvestrant | Patients were men and postmenauposal women with locally advanced confirmed HR positive, HER2 negative breast cancer | 169 / 172 | low | conclusif |
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