metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
breast cancer - adjuvant breast cancer - adjuvant
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
	PALLAS, 2022 J Clin Oncol 2022; 40:282-293-. Lancet Oncol 2021; 22:212-222-. J Clin Oncol 2022; 40:449-458-. NCT02513394	RCT	breast cancer - adjuvant			Patients with histollogically confirmed stage II or III HR-positive BC. Before random assignment, patients had completed definitive breast surgery (and (neo)adjuvantchemotherapy and/or radiotherapy, if indicated)	2884 / 2877	NA	inconclusive	no statistically significant result
	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 placebo
	everolimus
	Bachelot, 2022 J Clin Oncol 2022 May 23;JCO2102179. NCT01805271	RCT	breast cancer - adjuvant	everolimus for 2 years combined with standard endocrine therapy	placebo for 2 years combined with standard placebo	women with high-risk, hormone receptor-positive, human epidermal growth factor receptor 2-negative primary breast cancer	-/-	NA	inconclusive	no statistically significant result
	neratinib
	ExteNET, 2016 Lancet Oncol. 2017; 18:1688-1700 Lancet Oncol 2016 Mar;17(3):367-377. Ann Oncol 2019 Apr 1;30(4):567-574. Future Oncol 2019 Jul;15(21):2489-2501. Breast Cancer Res 2019; 21:39-. Breast Cancer Res 2019; 21:32-. Clin Breast Cancer 2021; 21:80-91.e7-. NCT00878709	RCT	breast cancer - adjuvant, la/mBC - HER2 positive - 2nd Line (L2)	neratinib	placebo	Women with locally confirmed invasive HER2-positive BC stage 1-3, who had received trastuzumab and chemotherapy.	1420 / 1420	low	conclusif	demonstrated 33 % decrease in iDFS,iDFS (PE) suggested 37 % decrease in RFS/DFS,RFS/DFS
	olaparib
	OlympiA (BIG 6-13, NSABP B-55) unpublished New England Journal of Medicine NCT02032823	RCT	es-BC - TNBC - NA - all population	olaparib	placebo	patients with human epidermal growth factor receptor 2 (HER2)–negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors	921 / 915	NA	conclusif	demonstrated 32 % decrease in deaths (OS) (PE) demonstrated 42 % decrease in iDFS (PE)
	pembrolizumab alone
	KEYNOTE-522, 2020 N. Engl. J. Med. 2020; 382:810-821 N Engl J Med 2022; 386:556-567-. NCT03036488	RCT	es-BC - TNBC - NA - all population	pembrolizumab	placebo	previously previously untreated, nonmetastatic disease, stage II or stage III, triple-negative breast cancer treated with paclitaxel and carboplatin, treated for neoadjuvant phase and an adjuvant phase;	784 / 390	low	conclusif	demonstrated 12.6-fold increase in pCR (PE) suggested 37 % decrease in events or deaths (EFS) (PE)
versus trastuzumab
	trastuzumab emtansine
	KATHERINE, 2019 N Engl J Med 2019; 380:617-628-. Ann Oncol 2021; 32:1005-1014-. Cancer 2020; 126:3132-3139-. Breast Cancer Res Treat 2021; 187:759-768-. NCT01772472	RCT	es-BC - HER2 positive - (neo)adjuvant (NA)	trastuzumab emtasine (T-DM1)	trastuzumab	Patients had histologically confirmed, HER2-positive, nonmetastatic, invasive primary breast cancer and if residual invasive disease after completion of taxane-based neoadjuvant chemotherapy ad and had to have completed at least six cycles (16 weeks) of a conventional preoperative chemotherapy regimen containing a minimum of 9 weeks of taxane-based therapy and 9 weeks of trastuzumab therapy.	743 / 743	high	conclusif	inconclusive 30 % decrease in deaths (OS) (PE) demonstrated 50 % decrease in iDFS (PE)

breast cancer - adjuvant breast cancer - adjuvant