metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	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 N. Engl. J. Med. 2019; 380:1929-1940 Ann Oncol 2021; 32:208-217-. 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	inconclusive 14 % decrease in deaths (OS) (PE) demonstrated 35 % decrease in progression or deaths (PFS) (PE)
	SOLAR-1 (patients without PIK3CA mutant status), 2019 N. Engl. J. Med. 2019; 380:1929-1940 Ann Oncol 2021; 32:208-217-. 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	inconclusive 15 % decrease in progression or deaths (PFS) (PE)
	buparlisib plus fulvestrant
	BELLE-3, 2018 Lancet Oncol 2018; 19:87-100-. NCT01633060	RCT	la/mBC - HR-positive - 2nd line (L2)	buparlisib plus fulvestrant	placebo plus fulvestrant	Postmenopausal women (aged >= 18yr) with HR-positive, HER2-negative, locally advanced or metastatic breast cancer pretreated with aromatase inhibitors and resistant to endocrine therapy for advanced BC.	289 / 143	NA	conclusif	demonstrated 33 % decrease in progression or deaths (PFS) (PE)
la/mBC - HR positive - L2 - all population breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 2nd line (L2) la/mBC - HR positive - L2 - all population
versus fulvestrant
	buparlisib plus fulvestrant
	BELLE-2 (full population), 2017 Lancet Oncol 2017; 18:904-916-. Eur J Cancer 2018; 103:147-154-. NCT01610284	RCT	la/mBC - HR positive - L2 - all population	buparlisib plus fulvestrant	placebo plus fulvestrant	Postmenopausal women (>=18yr), with histollogically confirmed HR-positive and HER2-negative inoperable locally advanced or metastatic breast cancer (with progession on or after aromatase ihnibitor treatment)	576 / 571	low	conclusif	inconclusive 13 % decrease in deaths (OS) (PE) demonstrated 22 % decrease in progression or deaths (PFS) (PE)
la/mBC - HR positive - L2 - PIK3CA mutant breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 2nd line (L2) la/mBC - HR positive - L2 - PIK3CA mutant
versus fulvestrant
	buparlisib plus fulvestrant
	BELLE-2 (PI3K pathway activated), 2017 Lancet Oncol 2017; 18:904-916-. NCT01610284	RCT	la/mBC - HR positive - L2 - PIK3CA mutant	buparlisib plus fulvestrant	placebo plus fulvestrant	Postmenopausal women (>=18yr), with histollogically confirmed HR-positive and HER2-negative inoperable locally advanced or metastatic breast cancer (with progession on or after aromatase ihnibitor treatment). This subgroup population included only patients with PI3K pathway activated	188 / 184	low	suggested	suggested 24 % decrease in progression or deaths (PFS) (PE)