metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results	deaths (OS) E	progression or deaths (PFS) E	RFS/DFS E
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
	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

Study

study type

Pathology

T1

T0

Patients

sample sizes

ROB

Results

deaths (OS) E

progression or deaths (PFS) E

RFS/DFS E

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

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

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