Phase II Trial With Metronomic, Capecitabine Plus Oral Vinorelbine for Metastatic Breast Cancer

Sponsor
University of Aarhus
Study ID
NCT01941771
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The study hypothesis is that metronomic treatment is more efficient than standard treatment.

Key Dates

Start date
Jun 30, 2012
Status verified
Oct 2016
Primary completion
Jan 31, 2015
Completion
Mar 31, 2015

Study Design

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

Arms

  • Active Comparator: Arm A
    Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule.
  • Experimental: Arm B
    Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule.

Primary Outcome Measure

Primary endpoint is overall response rate i both arms. [ Time Frame: up to 60 month ]

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