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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
trastuzumab plus endocrine therapy (n=196) vs. trastuzumab plus chemotherapy (n=196)
randomized controlled trial
trastuzumab plus endocrine therapy
trastuzumab: on day 1 of study treatment as an initial loading dose of 8 mg/kg. Subsequent dosing and scheduling of trastuzumab was 6 mg/kg every 3 weeks / endocrine therapy
trastuzumab plus chemotherapy
trastuzumab: on day 1 of study treatment as an initial loading dose of 8 mg/kg. Subsequent dosing and scheduling of trastuzumab was 6 mg/kg every 3 weeks / chemotherapy
la/mBC - HR-positive - 1st line (L1)
open label
in 9 hospitals in China
P3 / nononferiority, PFS at 0.025 and HR <1.35 / All efficacy analysis will be performed based on the ITT population
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