Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00706069
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Vinorelbine oral — DRUG
    Vinorelbine at dose levels of 30mg, 40mg, 50mg, 60mg oral every Monday, Wednesday and Friday
  • Capecitabine — DRUG
    Capecitabine at dose levels of 800 mg/m2, 950mg/m2, 1100mg/m2, 1250mg/m2 per os from day 1 to day 14 every 21 days

Study Details

This study will evaluate the toxicity and secondary the efficacy of the combination vinorelbine plus capecitabine in metastatic breast cancer patients

Key Dates

Start date
Jun 30, 2008
Status verified
Dec 2009
Primary completion
Jul 31, 2009
Completion
Jul 31, 2009

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Vinorelbine oral plus Capecitabine

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of vinorelbine oral plus capecitabine combination [ Time Frame: Toxicity assessment at 1st cycle ]

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