metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
la/mBC - HER2 positive - 2nd Line (L2) breast cancer - HER2-positive la/mBC - HER2 positive la/mBC - HER2 positive - 2nd Line (L2)
versus lapatinib plus capecitabine
	neratinib plus capecitabine
	NALA, 2020 Oncologist 2021; 26:e1327-e1338-. J Clin Oncol 2020; 38:3138-3149-. NCT01808573	RCT	la/mBC - HER2 positive - 2nd Line (L2)	neratinib plus capecitabine	lapatinib plus capecitabine	Pateints with centrally confirmed HER2-positive mBC, and ≥ 2 previous HER2-directed therapies for mBC. Patients with brain metastases were eligible unless they had symptomatic or unstable brain metastases.	307 / 314	some concern	conclusif	inconclusive 12 % decrease in deaths (OS) (PE) demonstrated 24 % decrease in progression or deaths (PFS) (PE)
	NALA (brain metastases), 2020 Oncologist 2021; 26:e1327-e1338-. J Clin Oncol 2020; 38:3138-3149-. NCT01808573	RCT	la/mBC - HER2 positive - 2nd Line (L2)	neratinib plus capecitabine	lapatinib plus capecitabine	Patients with centrally confirmed HER2-positive mBC, and ≥ 2 previous HER2-directed therapies for mBC. Patients with brain metastases were eligible unless they had symptomatic or unstable brain metastases.For this comparison, patients with brain metastases	51 / 50	some concern	inconclusive	no statistically significant result
versus placebo
	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 (PE) suggested 37 % decrease in RFS/DFS