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 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)