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lapatinib plus capecitabine (n=43) vs. trastuzumab plus capecitabine (n=43)
randomized controlled trial
lapatinib plus capecitabine
lapatinib: 1250 mg/day / capecitabine: 2000 mg/m2/day on days 1-14 every 3 weeks
trastuzumab plus capecitabine
trastuzumab: 4 mg/kg loading then 2 mg/kg weekly or 8 mg/kg loading then 6 mg/kg every 3 weeks / and capecitabine: 2500 mg/m2/day on days 1-14 every 3 weeks
la/mBC - HER2 positive - 2nd Line (L2)
Exclusion criteria: patients with symptomatic brain metastases
open label
28 institutions in Japan
P2 / PFS at 1-sided at 0.10
the study did not met its primary endpoint, lapatinib plus capecitanine did not improve PFS compare to trastuzumab plus capecitabine
lapatinib plus trastuzumab (n=148) vs. lapatinib (n=148)
randomized controlled trial
lapatinib plus trastuzumab
lapatinib: PO 1000mg/day / trastuzumab: IV 2 mg/kg weekly (after the initial 4 mg/kg loading dose)
lapatinib monotherapy
lapatinib: PO 1500mg/day
cross-over population was comprised of 73 patients (49%) who, after documented disease progression after a minimum of 4 weeks of lapatinib monotherapy, opted to receive the combinationtreatment.
la/mBC - HER2 positive - 2nd Line (L2)
open label
88 centers in North America and Europe
P3 / PFS (in ITT population) at 2-sided alpha = 0.05 / no IA planned / The study was not powered for inference testing of the secondary end points.
the study met its primary endpoints, PFS was significantly increased in the combination group compare to lapatinib alone.
lapatinib plus fulvestrant (n=-9) vs. fulvestrant (n=-9)
randomized controlled trial
lapatinib plus fulvestrant
lapatinib: 1500mg/day PO / fulvestrant: day 1, 500 mg IM; days 15 and 28 and every 28 days thereafter, 250 mg IM, without dose modifications
placebo plus fulvestrant
placebo / fulvestrant: day 1, 500 mg IM; days 15 and 28 and every 28 days thereafter, 250 mg IM, without dose modifications
Patients with grade 2 diarrhea or rash resulting from lapatinib had treatment held until resolution of symptoms to at least grade 1 before resuming therapy; those with grade 3 diarrhea or rash could resume lapatinib after similar resolution of symptoms but with dose reduced to 1,000 mg per day.
la/mBC - HR-positive - 1st line (L1)
double blind
368 sites in US
P3 / PFS at 1-sided, alpha at 0.025 / Interim analyses of PFS will be conducted on a semiannual basis: 5IA (nominal alpha: 1st IA: <.001; 2nd IA: <.001; 3rd IA: 0.004; 4th IA: 0.011; 5th IA: 0.016; and a final analysis: 0.019).
Study was closed at the 3rd IA in June 2010, because futility boundary was crossed. Adding lapatinib did not improve PFS compare to placebo for patients with HR-positive breast cancer
lapatinib plus letrozole (n=642) vs. letrozole (n=644)
randomized controlled trial
lapatinib plus letrozole
lapatinib: PO 1500mg/day / letrozole: PO 2.5mg/day
placebo plus letrozole
letrozole: PO 2.5mg/day
no cross over was permitted at the time of progression
la/mBC - HR-positive - 1st line (L1)
double blind
P3 / PFS at level of 0.05 in HER2 positive population then in the ITT population
Adding lapatinib to letrozole improve significantly PFS for patients with HR-positive breast cancer
lapatinib plus letrozole (n=111) vs. letrozole (n=108)
randomized controlled trial
lapatinib plus letrozole
lapatinib: PO 1500mg/day / letrozole: PO 2.5mg/day
placebo plus letrozole
letrozole: PO 2.5mg/day
no cross over was permitted at the time of progression
la/mBC - HR-positive - 1st line (L1)
double blind
P3 / PFS at level of 0.05 in HER2 positive population then in the total population
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