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
versus trastuzumab plus capecitabine
	tucatinib plus trastuzumab plus capecitabine
	HER2CLIMB (patients with brain metastases), 2020 N Engl J Med 2020 Feb 13;382(7):597-609. NCT02614794	RCT	la/mBC - HER2 positive - 2nd Line (L2)	tucatinib plus trastuzumab plus capecitabine	placebo plus trastuzumab plus capecitabine	Patients with HER2-positive advanced breast cancer, had previously been treated with trastuzumab, pertuzumab, and trastuzumab emtansine. Patients with brain metastases were included unless they were in need of immediate local intervention (enrolled subsequently), or with untreated brain metastases larger than 2 cm in diameter could be enrolled with approval from the medical monitor.	198 / 93	low	conclusif	demonstrated 52 % decrease in progression or deaths (PFS) (PE)
	HER2CLIMB, 2020 N Engl J Med 2020 Feb 13;382(7):597-609. J Clin Oncol 2020; 38:2610-2619-. NCT02614794	RCT	la/mBC - HER2 positive - 2nd Line (L2)	tucatinib plus trastuzumab plus capecitabine	placebo plus trastuzumab plus capecitabine	Patients with HER2-positive advanced breast cancer, had previously been treated with trastuzumab, pertuzumab, and trastuzumab emtansine. Patients with brain metastases were included unless they were in need of immediate local intervention (enrolled subsequently), or with untreated brain metastases larger than 2 cm in diameter could be enrolled with approval from the medical monitor.	410 / 202	low	conclusif	demonstrated 34 % decrease in deaths (OS) (PE) demonstrated 46 % decrease in progression or deaths (PFS) (PE)