metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
la/mBC - HR-positive - 1st line (L1) breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 1st line (L1)
versus aromatase inhibitor
	abemaciclib plus aromatase inhibitor
	MONARCH 3, 2017 J Clin Oncol 2017 Nov 10;35(32):3638-3646. Oncologist 2020; 25:e1346-e1354-. NCT02246621	RCT	la/mBC - HR-positive - 1st line (L1)	abemaciclib plus a nonsteroidal aromatase inhibitor	placebo plus a nonsteroidal aromatase inhibitor	Postmenopausal women (aged 18 or more)with locally advanced HR-positive, HER2-negative locoregionally recurrent BC	328 / 165	low	conclusif	demonstrated 46 % decrease in progression or deaths (PFS) (PE)
versus endocrine therapy
	abemaciclib plus endocrine therapy
	MonarchE, 2021 Oncologist 2021; 26 Suppl 2:S5-S6-. J Clin Oncol 2020 Dec 1;38(34):3987-3998. Ann Oncol 2021; 32:1571-1581-. NCT03155997	RCT	la/mBC - HR-positive - 1st line (L1)	abemaciclib plus endocrine therapy	endocrine therapy	Patients (women and men) with HR-positive and HER2-negative breast cancer. Radiotherapy and both adjuvant and neoadjuvant chemotherapy were allowed, but not required.	2808 / 2829	high	conclusif	demonstrated 25 % decrease in iDFS (PE)
	palbociclib plus endocrine therapy
	PENELOPE-B, 2021 J Clin Oncol 2021; 39:1518-1530-. Oncologist 2021; 26 Suppl 2:S7-S8-. NCT01864746	RCT	la/mBC - HR-positive - 1st line (L1)	palbociclib plus endocrine therapy according to local standars (physician's choice)	placebo plus endocrine therapy according to local standars (physician's choice)	Women with residual invasive disease after NACT (NACT during at least 16 weeks) in the breats or in lymph nodes, ER and/or PR positive and HER2 negative tumor.	628 / 616	low	inconclusive	inconclusive 7 % decrease in iDFS (PE)
versus exemestane plus ridaforolimus
	dalotuzumab plus ridaforolimus plus exemestane
	MK-8669-064, 2017 Breast Cancer Res Treat 2017; 165:601-609-. NCT01605396	RCT	la/mBC - HR-positive - 1st line (L1)	dalotuzumab plus ridaforolimus plus exemestane	ridaforolimus plus exemestane	Patients with metastatic or locally advanced ER-positive and HER2-negative BC	40 / 40	some concern	inconclusive	inconclusive 18 % increase in progression or deaths (PFS) (PE)
versus fulvestrant
	cediranib plus fulvestrant
	NCT00454805, 2013 Invest New Drugs 2013; 31:1345-54-. NCT00454805	RCT	la/mBC - HR-positive - 1st line (L1)	cediranib plus fulvestrant	fulvestrant	Postmenopausal women with histologically/cytologically confirmed hormone-sensitive BC, with evidence of metastatic disease.	-/-	high	inconclusive	inconclusive 13 % decrease in progression or deaths (PFS) (PE)
	lapatinib plus fulvestrant
	CALGB 40302, 2014 J Clin Oncol 2014; 32:3959-66-. NCT00390455	RCT	la/mBC - HR-positive - 1st line (L1)	lapatinib plus fulvestrant	placebo plus fulvestrant	Postmenauposal women with stage III or IV HR-positive BC (Er and/or PR positive). Originally with HER2-positive, then an amendment to include tumors regardless of HER2 status. Patients had one or two prior endocrine treatments for at least 3 months without tumor progression in either the adjuvant or metastatic setting.	-/-	NA	suggested	inconclusive 4 % increase in progression or deaths (PFS) (PE)
versus letrozole
	lapatinib plus letrozole
	EGF30008 (all population), 2009 J Clin Oncol 2009; 27:5538-46-. NCT00073528	RCT	la/mBC - HR-positive - 1st line (L1)	lapatinib plus letrozole	placebo plus letrozole	Postmenopausal women with histologically confirmed stage IIIB/IIIC or IV, with HR positive. No prior therapy for advanced/metastatic BC was allowed, bu prior (neo)adjuvant antiestrogen therapy was allowed.	642 / 644	NA	conclusif	demonstrated 14 % decrease in progression or deaths (PFS) (PE)
	EGF30008 (HER2-positive), 2009 J Clin Oncol 2009; 27:5538-46-. NCT00073528	RCT	la/mBC - HR-positive - 1st line (L1)	lapatinib plus letrozole	placebo plus letrozole	Postmenopausal women with histologically confirmed stage IIIB/IIIC or IV, with HR positive. No prior therapy for advanced/metastatic BC was allowed, bu prior (neo)adjuvant antiestrogen therapy was allowed.	111 / 108	NA	conclusif	demonstrated 29 % decrease in progression or deaths (PFS) (PE) statistically significant 60 % decrease in CBR statistically significant 60 % decrease in objective responses (ORR) Adding lapatinib to letrozole improve significantly PFS for patients with HR-positive and HER2-positive breast cancer
	palbociclib plus letrozole
	PALOMA-1, 2016 Breast Cancer Res 2016; 18:67-. Lancet Oncol 2015 Jan;16(1):25-35. Breast Cancer Res Treat 2020 Sep;183(2):419-428. NCT00721409	RCT	la/mBC - HR-positive - 1st line (L1)	palbociclib plus letrozole	letrozole	Postmenopausal women with ER-positive and HER2-negative advanced breast cancer. Enrolled in 2 separate cohorts (cohort 1: ER-positive and HER2-negative / cohort 2: they were also required to have cancers with amplification of cyclin D1 (CCND1), loss of p16 (also known as INK4A or CDKN2A), or both)	84 / 81	high	suggested	suggested 51 % decrease in progression or deaths (PFS) (PE)
	PALOMA-2, 2016 N Engl J Med 2016; 375:1925-1936-. Breast Cancer Res Treat 2019; 174:719-729-. Clin Breast Cancer 2020; 20:e173-e180-. J Glob Oncol 2019; 5:1-19-. NCT01740427	RCT	la/mBC - HR-positive - 1st line (L1)	palbociclib plus letrozole	placebo plus letrozole	Postmenopausal women with ER-positive, HER2-negative advanced breast cancer were eligible for enrollment if they had not received prior systemic therapy for advanced disease.	444 / 222	NA	conclusif	demonstrated 42 % decrease in progression or deaths (PFS) (PE) suggested 44 % decrease in PFS (extension)
	ribociclib plus letrozole
	MONALEESA-2, 2016 N Engl J Med 2016; 375:1738-1748-. N Engl J Med 2022; 386:942-950-. Ann Oncol 2018; 29:1541-1547-. Breast Cancer Res Treat 2018; 168:127-134-. Breast Cancer Res Treat 2018; 167:659-669-. Clin Breast Cancer 2019; 19:268-277.e1-. NCT01958021	RCT	la/mBC - HR-positive - 1st line (L1)	ribociclib plus letrozole	placebo plus letrozole	Postmenauposal women with locally confirmed HR-positive, HER2-negative recurrent or metastatic BC who had not received previous systematic therapy for advanced disease	334 / 334	low	conclusif	demonstrated 24 % decrease in deaths (OS) (PE) demonstrated 44 % decrease in progression or deaths (PFS) (PE)
versus paclitaxel
	capivasertib plus paclitaxel
	BEECH, 2019 Ann Oncol 2019; 30:774-780-. NCT01625286	RCT	la/mBC - HR-positive - 1st line (L1)	capivasertib plus paclitaxel	placebo plus paclitaxel	patients with ER-positive advanced breast cancer with or without a PIK3CA mutation receiving chemotherapy for the first time in the advanced setting	54 / 56	low	inconclusive	inconclusive 20 % decrease in progression or deaths (PFS) (PE)
versus trastuzumab plus chemotherapy
	trastuzumab plus endocrine therapy
	SYSUCC-002, 2022 Clin Cancer Res 2022; 28:637-645-. NCT01950182	RCT	la/mBC - HER2 positive - 1st Line (L1), la/mBC - HR-positive - 1st line (L1)	trastuzumab plus endocrine therapy	trastuzumab plus chemotherapy	Female patients aged of 18 or more, with locally histology confirmed mBC, HR-positive (ER and/or PR-positive) and HER2-positive	196 / 196	some concern	inconclusive	inconclusive 12 % decrease in progression or deaths (PFS) (PE)
la/mBC - HR positive - L1 - PIK3CA mutant breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 1st line (L1) la/mBC - HR positive - L1 - PIK3CA mutant
versus paclitaxel
	ipatasertib plus paclitaxel
	IPATunity130, 2022 Breast Cancer Res Treat 2022; 191:565-576-. NCT03337724	RCT	la/mBC - HR positive - L1 - PIK3CA mutant	ipatasertib plus paclitaxel	placebo plus paclitaxel	Patients with HR-positive and HER2-negative PIK3CA/AKT1/PTEN-altered measurable advanced breast cancer	146 / 76	low	inconclusive	inconclusive 0 % increase in progression or deaths (PFS) (PE)

la/mBC - HR-positive - 1st line (L1) breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 1st line (L1)

la/mBC - HR positive - L1 - PIK3CA mutant breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 1st line (L1) la/mBC - HR positive - L1 - PIK3CA mutant