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Sponsored by: |
Central European Cooperative Oncology Group |
---|---|
Information provided by: | Central European Cooperative Oncology Group |
ClinicalTrials.gov Identifier: | NCT00600340 |
First-line treatment of patients with locally recurrent or metastatic, HER2-negative breast cancer who have not received prior chemotherapy for locally recurrent or metastatic disease.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Biological: Bevacizumab and Paclitaxel Biological: Bevacizumab and Capecitabine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase III 2-Arm Trial of Paclitaxel Plus Bevacizumab vs. Capecitabine Plus Bevacizumab for the First-Line Treatment of HER2-Negative Locally Recurrent or Metastatic Breast Cancer |
Estimated Enrollment: | 560 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks |
Biological: Bevacizumab and Paclitaxel |
B: Active Comparator
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks. In both arms, treatment will be given until first disease progression (PD), unacceptable toxicity or withdrawal of patient consent. |
Biological: Bevacizumab and Capecitabine |
Arm A:
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks
Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
Arm B:
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks
Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
In both arms treatment will be given until first disease progression (PD), unacceptable toxicity or withdrawal of patient consent.
For patients who stop chemotherapy for any reason before PD (e.g. toxicity) the other treatment should be given as monotherapy until PD.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Prior (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was more than 6 months prior to randomization. However, if (neo)adjuvant chemotherapy was:
Taxane-based, patients are eligible only if they received their last taxane more than 12 months prior to randomization.
Anthracycline-based, the maximum cumulative dose of prior anthracycline therapy must not exceed 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin.
Prior adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that last fraction of radiotherapy occurred at least 6 months prior to randomization. Radiotherapy administered solely for the relief of metastatic bone pain is allowed prior to study entry, providing that:
Exclusion Criteria:
Contact: Barbara Planko, Mag(FH) | +4314097725 | barbara.planko@cecog.at |
Austria | |
2. Med. Abteilung - LKH-Steyr | |
Steyr, Austria, 4400 | |
Bosnia and Herzegovina | |
Institute of Oncology Sarajevo | |
Sarajevo, Bosnia and Herzegovina | |
Bulgaria | |
Cancer Center Plovdiv | |
Plovdiv, Bulgaria, 4000 | |
Croatia | |
University Hospital for Tumors | |
Zagreb, Croatia | |
Univ. Hospital, Dep of Pathophysiology | |
Split, Croatia | |
GH, Dep Oncology and Reumatology | |
Varazdin, Croatia | |
University Hospital Rebro | |
Zagreb, Croatia | |
Czech Republic | |
Charles University Prague, Dep of Oncology | |
Prague, Czech Republic | |
Hungary | |
Markusovszky Hospital | |
Szombathely, Hungary | |
Onkotherápiás Klinika, | |
Szeged, Hungary | |
Israel | |
Tel Aviv Sourasky Medical Center, Div of Oncology | |
Tel Aviv, Israel | |
Slovakia | |
Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav | |
Bratislava, Slovakia, 81250 | |
Oncology Institute, Department of Radiotherapy and Onclogy | |
Kosice, Slovakia, 04191 |
Principal Investigator: | Christoph C Zielinski, MD | Dep. of Internal Medicin I, Oncology, Medical University of Vienna |
Responsible Party: | CECOG ( CECOG ) |
Study ID Numbers: | CECOG/BC1.3.005 |
Study First Received: | January 14, 2008 |
Last Updated: | January 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00600340 |
Health Authority: | Austria: Agency for Health and Food Safety |
Capecitabine Skin Diseases Paclitaxel Breast Neoplasms |
Bevacizumab Breast Diseases Recurrence |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |