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

Randomized Phase II Trial of Capecitabine Plus Oral Vinorelbine Day 1 and 8 vs Metronomic Capecitabine Plus Oral Vinorelbine as Treatment of Metastatic Breast Cancer.

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

Purpose: In an open-label randomized phase II trial, patients with metastatic Human Epidermal Growth Factor Receptor 2-negative breast cancer with normal organ function sant WHO performance status < 3 are randomized to receive either capecitabine (day 1-14) plus vinorelbine oral (day 1 and 8) or capecitabine (day 1-14) plus vinorelbine oral metronomic (3 days a week).

Inclusion Criteria:

• Locally advanced or metastatic Human Epidermal Growth Factor Receptor2-Negative breast cancer
• WHO performance status < 3

Exclusion Criteria:

• Former treatment with Capecitabine or Vinorelbine
• Patients who have received more than one line of chemotherapy for metastatic disease
• Brain metastases
• Malabsorption syndrome
• Abnormal organ function
• pregnant or lactating women