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 letrozole
	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 - 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
	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)

Study

study type

Pathology

Patients

sample sizes

ROB

Results

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

demonstrated 24 % decrease in deaths (OS) (PE)
demonstrated 44 % decrease in progression or deaths (PFS) (PE)

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

demonstrated 45 % decrease in progression or deaths (PFS) (PE)

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

demonstrated 28 % decrease in deaths (OS) (PE)
demonstrated 41 % decrease in progression or deaths (PFS) (PE)
suggested 27 % decrease in deaths (OS) (extension)

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

versus letrozole

ribociclib plus letrozole

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

versus fulvestrant

ribociclib plus fulvestrant