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 endocrine therapy
	ribociclib plus endocrine therapy
	MONALEESA-7, 2018 Lancet Oncol 2018; 19:904-915-. Clin Cancer Res 2022; 28:851-859-. N Engl J Med 2019; 381:307-316-. NCT02278120	RCT	la/mBC - HR-positive - 2nd line (L2)	ribociclib plus endocrine therapy plus goserelin	placebo plus endocrine therapy plus goserelin	Women premenopausal or perimenopausal at the time of entry, with histologically or cytologically confirmed HR-positive and HER2-negative breast cancer.	335 / 337	low	conclusif	demonstrated 45 % decrease in progression or deaths (PFS) (PE)
versus fulvestrant
	abemaciclib plus fulvestrant
	MONARCH 2, 2020 JAMA Oncol 2020; 6:116-124-. Breast Cancer Res 2021; 23:87-. J Clin Oncol 2017 Sep 1;35(25):2875-2884. Oncologist 2020; 25:e243-e251-. NCT02107703	RCT	la/mBC - HR-positive - 2nd line (L2)	abemaciclib plus fulvestrant	placebo plus fulvestrant	Women with HR-positive and HER2-negative advanced breast (ABC) cancer who progressed during neoadjuvant or adjuvantendocrine therapy (ET), within 12months after adjuvant ET, or while receiving first line ET for ABC	446 / 223	low	conclusif	demonstrated 24 % decrease in deaths (OS) (PE) demonstrated 45 % decrease in progression or deaths (PFS) (PE)
	dalpiciclib plus fulvestrant
	DAWNA-1, 2021 Nat Med 2021; 27:1904-1909-. NCT03927456	RCT	la/mBC - HR-positive - 2nd line (L2)	dalpiciclib plus fulvetrant	placebo (matching dulpaciclib) plus fulvestrant	Women aged of 18-75yr with pathologically confirmed HR-positive and HER2-negative locally advanced or metastatic BC. Nor more than 1 previous chemotherapy for advanced disease.	241 / 120	low	conclusif	demonstrated 58 % decrease in progression or deaths (PFS) (PE)
	palbociclib plus fulvestrant
	FLIPPER, 2021 Eur J Cancer 2022; 161:26-37-. NCT02690480	RCT	la/mBC - HR-positive - 2nd line (L2)	palbociclib plus fulvestrant	placebo plus fulvestrant	Postmenauposal women with HR-positive and HER-negative advanced breast cancer	94 / 95	low	suggested	suggested 45 % decrease in progression or deaths (PFS) (PE)
	PALOMA-3, 2016 Oncologist 2021; 26 Suppl 3:S5-S6-. Oncologist 2016; 21:1165-1175-. Lancet Oncol 2016; 17:425-439-. N Engl J Med 2015; 373:209-19-. Oncologist 2017; 22:1028-1038-. N Engl J Med 2018; 379:1926-1936-. Int J Clin Oncol 2019; 24:262-273-. NCT01942135	RCT	la/mBC - HR-positive - 2nd line (L2)	palbociclib plus fulvestrant	placebo plus fulvestrant	Eligible patients were pre- or post menopausal with breast cancer and histologic or cytologicconfirmation of recurrent local or distant disease progression during or within 12 months of completion of adjuvant endocrinetherapy or while receiving or within 1 month after receivingendocrine therapy for MBC	347 / 174	low	conclusif	inconclusive 19 % decrease in deaths (OS) (PE) demonstrated 58 % decrease in progression or deaths (PFS) (PE)
	ribociclib plus fulvestrant
	MONALEESA-3, 2018 J Clin Oncol 2018 Aug 20;36(24):2465-2472. N Engl J Med 2020 Feb 6;382(6):514-524. Ann Oncol 2021 Aug;32(8):1015-1024. NCT02422615	RCT	la/mBC - HR-positive - 2nd line (L2)	ribociclib plus fulvestrant	placebo plus fulvestrant	Postmenopausal women and men with confirmed HR-positive and HER2-negative advanced/metastatic breast cancer	484 / 242	low	conclusif	demonstrated 28 % decrease in deaths (OS) (PE) demonstrated 41 % decrease in progression or deaths (PFS) (PE) suggested 27 % decrease in deaths (OS) (extension)