Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)

Sponsor
Fudan University
Study ID
NCT00629148
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The primary objective of this study is to evaluate the efficacy and tolerability of sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.

Key Dates

Start date
Aug 31, 2007
Status verified
Jun 2011
Primary completion
Aug 31, 2009
Completion
Dec 31, 2010

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: combination chemotherapy
    Simultaneous use of Vinorelbine and Capecitabine
  • Experimental: sequential chemotherapy
    Sequential use of Vinorelbine and Capecitabine

Primary Outcome Measure

PFS(progression-free survival,defined as the time period between randomization and disease progress or death) and TTF (time to treatment failure, defined as all discontinuations for any cause) [ Time Frame: Every two cycles (3 weeks per cycle) and during the follow up time, until disease progression event occurs. ]

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