Vinorelbine Metronomic Plus Lapatinib for Overexpressing HER-2 Metastatic Breast Cancer

Sponsor
University Hospital of Crete
Study ID
NCT00754702
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    Vinorelbine p.o (50 mg 3 times a week) until disease progression or appearance of unacceptable toxicity
  • Lapatinib — DRUG
    Lapatinib p.o every day without interruption disease progression or appearance of unacceptable toxicity

Study Details

The purpose of this study is to evaluate the safety and efficacy of metronomic oral vinorelbine taken three times a week plus daily lapatinib without break, as salvage treatment in patients with metastatic breast cancer.

Key Dates

Start date
Oct 31, 2008
Status verified
Sep 2015
Primary completion
Mar 31, 2011
Completion
Mar 31, 2011

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Vinorelbine metronomic/Lapatinib

Primary Outcome Measure

Overall response rate [ Time Frame: 3 - 6 month ]

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