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Sponsors and Collaborators: |
iOMEDICO AG Arbeitsgemeinschaft fur Internistische Onkologie Arbeitskreis klinische Studien (AKS) Hoffmann-La Roche |
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Information provided by: | iOMEDICO AG |
ClinicalTrials.gov Identifier: | NCT00868634 |
The aim of the trial is to detect the superiority of the triple combination of capecitabine, bevacizumab and vinorelbine vs. the combination of capecitabine and bevacizumab in patients with metastatic breast cancer. 400 patients, 200 in each treatment group, are treated until progression of disease to determine PFS.
Condition | Intervention | Phase |
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Metastatic Breast Cancer |
Drug: capecitabine Drug: bevacizumab Drug: vinorelbine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Capecitabine and Bevacizumab ± Vinorelbine as 1st Line Treatment in HER-2 Negative Metastatic or Locally Advanced Inoperable Breast Cancer Patients |
Estimated Enrollment: | 400 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | March 2014 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator |
Drug: capecitabine
1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
Drug: bevacizumab
15 mg/kg i.v., day 1 Cycles are repeated every three weeks.
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B: Experimental |
Drug: capecitabine
1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
Drug: bevacizumab
15 mg/kg i.v., day 1. Cycles are repeated every three weeks.
Drug: vinorelbine
25 mg/m2 i.v., days 1+8. Cycles are repeated every three weeks.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contact: Annette Hipper, PhD | ++ 49 761-15242-0 | info@iomedico.com |
Germany | |
Onkologische Schwerpunktpraxis Eppendorf | Recruiting |
Hamburg, Germany | |
Principal Investigator: Hegwisch-Becker, MD |
Principal Investigator: | Susanna Hegewisch-Becker, MD | Onkologische Schwerpunktpraxis Eppendorf |
Responsible Party: | iOMEDICO AG ( Annette Hipper, PhD ) |
Study ID Numbers: | IOM-080-2, EudraCT-Nr.: 2008-003779-37 |
Study First Received: | March 23, 2009 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00868634 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Antimetabolites Capecitabine Vinorelbine Skin Diseases Breast Neoplasms |
Bevacizumab Angiogenesis Inhibitors Antineoplastic Agents, Phytogenic Breast Diseases |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Breast Neoplasms Bevacizumab |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Vinorelbine Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic Breast Diseases |