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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
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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Department of Oncology, Aarhus University Hospital, Aarhus, Aarhus C, Denmark
Name: Sven Tyge Langkjer, MD, PhD
Affiliation: University hospital of Aarhus
Role: PRINCIPAL_INVESTIGATOR