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
	lapatinib plus trastuzumab
	EGF104900, 2010 J Clin Oncol 2012; 30:2585-92-. Journal of Clinical Oncology NCT00320385	RCT	la/mBC - HER2 positive - 2nd Line (L2)	lapatinib plus trastuzumab	lapatinib monotherapy	Patients with HER2-positive mBC who had experienced progression on prior trastuzumab-based therapy. Patients must have received prior anthracycline- and taxane-based regimens in either the adjuvant or metastatic setting.	148 / 148	some concern	suggested	suggested 26 % decrease in deaths (OS) suggested 26 % decrease in progression or deaths (PFS) (PE)
versus trastuzumab plus capecitabine
	lapatinib plus capecitabine
	WJOG6110B/ELTOP, 2018 Breast 2018; 40:67-75-. UMIN000005219	RCT	la/mBC - HER2 positive - 2nd Line (L2)	lapatinib plus capecitabine	trastuzumab plus capecitabine	Women, aged 20yr or older, cith HER2-positive mBC or unresectable locally advanced BC who were previously treated with taxanes, with progression on trastuzumab-containing regimens	43 / 43	NA	suggested	inconclusive 19 % decrease in progression or deaths (PFS) (PE)
la/mBC - HR-positive - 1st line (L1) breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 1st line (L1)
versus fulvestrant
	lapatinib plus fulvestrant
	CALGB 40302, 2014 J Clin Oncol 2014; 32:3959-66-. NCT00390455	RCT	la/mBC - HR-positive - 1st line (L1)	lapatinib plus fulvestrant	placebo plus fulvestrant	Postmenauposal women with stage III or IV HR-positive BC (Er and/or PR positive). Originally with HER2-positive, then an amendment to include tumors regardless of HER2 status. Patients had one or two prior endocrine treatments for at least 3 months without tumor progression in either the adjuvant or metastatic setting.	-/-	NA	suggested	inconclusive 4 % increase in progression or deaths (PFS) (PE)
versus letrozole
	lapatinib plus letrozole
	EGF30008 (HER2-positive), 2009 J Clin Oncol 2009; 27:5538-46-. NCT00073528	RCT	la/mBC - HR-positive - 1st line (L1)	lapatinib plus letrozole	placebo plus letrozole	Postmenopausal women with histologically confirmed stage IIIB/IIIC or IV, with HR positive. No prior therapy for advanced/metastatic BC was allowed, bu prior (neo)adjuvant antiestrogen therapy was allowed.	111 / 108	NA	conclusif	demonstrated 29 % decrease in progression or deaths (PFS) (PE) statistically significant 60 % decrease in CBR statistically significant 60 % decrease in objective responses (ORR) Adding lapatinib to letrozole improve significantly PFS for patients with HR-positive and HER2-positive breast cancer
	EGF30008 (all population), 2009 J Clin Oncol 2009; 27:5538-46-. NCT00073528	RCT	la/mBC - HR-positive - 1st line (L1)	lapatinib plus letrozole	placebo plus letrozole	Postmenopausal women with histologically confirmed stage IIIB/IIIC or IV, with HR positive. No prior therapy for advanced/metastatic BC was allowed, bu prior (neo)adjuvant antiestrogen therapy was allowed.	642 / 644	NA	conclusif	demonstrated 14 % decrease in progression or deaths (PFS) (PE)

la/mBC - HER2 positive - 2nd Line (L2) breast cancer - HER2-positive la/mBC - HER2 positive la/mBC - HER2 positive - 2nd Line (L2)

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