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

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Trial Identification

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

Official Title: 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.

Study ID: NCT01941771

Conditions

Breast Cancer

Interventions

Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Study Description

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

Detailed Description: 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).