Docetaxel/Epirubicin/Bevacizumab as First Line Therapy for Metastatic HER2 Negative Breast Cancer

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Treatments: Bevacizumab; Docetaxel; Epirubicin

Criteria

Inclusion Criteria:

• Histologically- or cytologically- confirmed metastatic breast adenocarcinoma

• No HER2 overexpression or gene amplification

• No previous therapy for metastatic breast cancer is allowed

• Age 18-75 years

• At least 12 months interval since prior adjuvant therapy with taxanes and/or anthracyclines

• Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)

• Performance status (WHO) 0-2

• Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the UNL in the presence of liver metastases)

• Adequate renal function (serum creatinine <1.5 times the upper normal limit

• Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)

• Written informed consent

Exclusion Criteria:

• Active infection

• Brain metastases

• History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)

• History of stroke

• Anticoagulation therapy (except of low dose aspirin <325mg)

• Other invasive malignancy except nonmelanoma skin cancer

• Psychiatric illness or social situation that would preclude study compliance

• Pregnant or lactating women