A Study Evaluating the Efficacy and Safety of Lapatinib + Vinorelbine in ErbB2 Positive Metastatic Breast Cancer Patients

Sponsor
Central European Cooperative Oncology Group
Study ID
NCT01161368
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Lapatinib, Vinorelbine — DRUG
    Lapatinib 1250mg orally once daily continuously plus Vinorelbine 20 mg/m2 intravenously (IV) once weekly \[Days 1 and 8\] for 2 weeks, followed by a rest week in a 3-week cycle.

Study Details

The objective of this phase II study is to gain first information on the efficacy (PFS, ORR and OS) and safety of lapatinib plus vinorelbine in patients with HER2 positive metastatic breast cancer pretreated with a combination therapy (chemotherapy and/or hormonal therapy) including lapatinib and presenting with tumor progression. Primary objective is to assess the efficacy with respect to the percentage of patients surviving without disease progression as assessed by RECIST criteria. Secondary objectives are to assess the efficacy of the study treatment with respect to the objective response rates as assessed by RECIST criteria version 1.1, the overall survival and to evaluate the safety profile of the combination by recording the adverse events and abnormal laboratory values associated with the study treatments. The main efficacy endpoints will be investigated both for the intent-to-treat (ITT) population and the per-protocol (PP) population.

Key Dates

Start date
Sep 30, 2010
Status verified
May 2014
Primary completion
May 31, 2014
Completion
May 31, 2014

Study Design

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

Arms

  • Experimental: lapatinib, vinorelbine
    Drug: Lapatinib, Vinorelbine Lapatinib 1250mg orally once daily continuously plus Vinorelbine 20 mg/m2 intravenously (IV) once weekly \[Days 1 and 8\] for 2 weeks, followed by a rest week in a 3-week cycle.

Primary Outcome Measure

Progressive Free Survival [ Time Frame: 4 years ]

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