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