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 letrozole
	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)

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