| Study | study type
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Pathology | T1 | T0 | Patients | sample sizes | ROB | Results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 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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| 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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