Lapatinib in Combination With Vinorelbine

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01013740
Phase
PHASE2
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

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

Interventions

  • Vinorelbine — DRUG
    Vinorelbine
  • Lapatinib — DRUG
    Lapatinib
  • Capecitabine — DRUG
    Capecitabine

Study Details

This is a randomized, parallel-arm, open-label, multi-centre, Phase II study to determine the efficacy and safety of lapatinib in combination with vinorelbine or capecitabine in women with ErbB2 overexpressing metastatic breast cancer (MBC) who have received no more than one chemotherapeutic regimen in the metastatic setting.

Key Dates

Start date
Nov 25, 2009
Status verified
Mar 2017
Primary completion
Aug 21, 2012
Completion
Mar 1, 2016

Study Design

Enrollment
112 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib + Vinorelbine
    Lapatinib + Vinorelbine
  • Active Comparator: Lapatinib + Capecitabine
    Lapatinib + Capecitabine

Primary Outcome Measure

Progression Free Survival (PFS) in the Randomized Phase [ Time Frame: From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks) ]

Related Studies