Lapatinib in Combination With Vinorelbine

Sponsor
GlaxoSmithKline
Study ID
NCT01128543
Phase
PHASE2
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lapatinib and Vinorelbine — DRUG
    Patients will receive 1250mg lapatinib once a day and vinorelbine 25mg/sqm IV Day 1and Day 8, every 3 week for 24 weeks.

Study Details

This is a Multicenter, Open-Label, Phase II Study of lapatinib in Combination with Vinorelbine in women with documented evidence of HER2/neu positive breast cancer which is metastatic or recurrent and with or without prior chemotherapy or anti-HER2/neu targeted therapy in the metastatic and relaps setting.

Key Dates

Start date
Apr 30, 2009
Status verified
Nov 2012
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012

Study Design

Enrollment
29 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: lapatinib 1250mg
    Patients will receive 1250mg lapatinib once a day for 24 weeks.
  • Active Comparator: Vinorelbine 25mg/sqm
    Patients will receive vinorelbine 25mg/sqm IV Day 1 and Day 8, every 3 week for 24 weeks.

Primary Outcome Measure

Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24 [ Time Frame: Week 12 and Week 24 ]

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