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A phase II , randomized , multicenter study evaluating the combination of lapatinib and vinorelbine in women with ErbB2 overexpressing metastatic breast cancer . Lapatinib is approved in combination with capecitabine for treatment of patients with human epidermal growth factor receptor 2 ( HER2 ) -positive metastatic breast cancer ( MBC ) who have progressed on prior trastuzumab in the metastatic setting . Vinorelbine is an important chemotherapy option for MBC . We evaluated efficacy and safety of lapatinib plus vinorelbine , compared with lapatinib plus capecitabine , in women with HER2-positive MBC . In this open-label , multicenter , phase II study , eligible patients ( N = 112 ) were randomized 2:1 to lapatinib plus vinorelbine [ ( N = 75 ) 1,250 mg orally once daily ( QD ) continuously plus 20 mg/m ( 2 ) /day intravenously ] or lapatinib plus capecitabine [ ( N = 37 ) 1,250 mg orally QD continuously plus 2,000 mg/m ( 2 ) /day orally , 2 doses ] . The primary endpoint was progression-free survival ( PFS ) . Other endpoints included overall survival ( OS ) and safety . Patients progressing within the study were given the option of crossover to the other treatment arm ; time to second progression was an exploratory endpoint . Patient demographics , stratification , and prognostic factors were well balanced between treatments . Median PFS in both arms was 6.2 months [ 95 % confidence interval ( CI ) 4.2 , 8.8 ( lapatinib plus vinorelbine ) ; 4.4 , 8.3 ( lapatinib plus capecitabine ) ] . Median OS on lapatinib plus vinorelbine was 24.3 months ( 95 % CI 16.4 , NE ) and 19.4 months ( 95 % CI 16.4 , 27.2 ) on lapatinib plus capecitabine . In total , 42 patients opted to cross over ; median PFS was 3.2 months ( 95 % CI 1.7 , 5.1 ) on lapatinib plus vinorelbine and 4.0 months ( 95 % CI 2.1 , 5.8 ) on lapatinib plus capecitabine . Lapatinib plus vinorelbine offers an effective treatment option for patients with HER2-overexpressing MBC , having displayed comparable efficacy and tolerability rates to lapatinib plus capecitabine .
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Intervention_Pharmacological
lapatinib plus vinorelbine
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Intervention_Pharmacological
lapatinib plus capecitabine
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Outcome_Mortality
progression-free survival ( PFS )
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Outcome_Mortality
overall survival ( OS ) and safety
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Outcome_Mental
Patient demographics
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Outcome_Physical
stratification
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Outcome_Physical
prognostic factors
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Outcome_Mortality
Median PFS
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Outcome_Mortality
Median OS
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Participant_Sex
women
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Participant_Condition
ErbB2 overexpressing metastatic breast cancer
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Participant_Condition
human epidermal growth factor receptor 2 ( HER2 ) -positive
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Participant_Sample-size
112