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 endocrine therapy
	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)