A Phase II, Randomised, Multi-Centre Study Evaluating Lapatinib in Combination With Vinorelbine or Capecitabine in Women With ErbB2 Overexpressing Metastatic Breast Cancer
Approximately 105 subjects will be enrolled in the study and randomized 2:1 to one of the
following regimens Arm A (n=70): Lapatinib 1250 mg orally once daily continuously plus
Vinorelbine 20mg/m2 intravenously (IV) on day 1 and 8, every third week, or Arm B (n=35):
Lapatinib 1250 mg orally once daily (QD) continuously plus Capecitabine 2000 mg/m2/day
orally in 2 doses 12 hours apart on days 1-14 every third week. Randomization will be
stratified according to the following variables: 1) Prior receipt of therapy for metastatic
breast cancer (Yes or No), and 2) Site of metastatic disease (Visceral/Soft tissue or
Bone-only). Subjects will receive randomized study treatment until disease progression or
discontinuation of study treatment due to unacceptable toxicity, withdrawal of consent, lost
to follow up, or death. All subjects who discontinue study treatment without documented
progression will continue to be followed for progression according to protocol-schedule
until new anti-cancer therapy is initiated and/or progression or death is documented.
Survival data will be collected for all subjects to ensure a minimum of 18 months survival
data. This study will include a safety run-in phase for approximately the first 30 subjects
(20 randomized to lapatinib and vinorelbine; 10 to lapatinib and capecitabine).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival (PFS) in the Randomized Phase
PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20 % increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion.
From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)
GSK Clinical Trials
Spain: Agencia Española del Medicamento y Productos Sanitarios