Phase II Trial With Metronomic, Capecitabine Plus Oral Vinorelbine for Metastatic Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Breast cancer, Metronomic chemotherapy, Vinorelbine, Navelbine, Capecitabine, Xeloda, Antineoplastic Agents
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda) Type: Drug
Name: Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda) Type: Drug
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
Department of Oncology, Aarhus University Hospital
Aarhus, Aarhus C, Denmark
Status: Recruiting
Contact: Sven Tyge Langkjer, MD, ph.d. - +45 7846 9721 - svenlang@rm.dk
Start Date
June 2012
Completion Date
December 2015
Sponsors
University of Aarhus
Source
University of Aarhus
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page