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

Hellenic Oncology Research Group

Status and phase

Completed

Phase 2

Phase 1

Conditions

Breast Cancer

Treatments

Drug: Bevacizumab

Drug: Docetaxel

Drug: Epirubicin

Study type

Interventional

Funder types

Other

Identifiers

NCT00705315

CT/07.21

Details and patient eligibility

About

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.

Full description

A phase II trial with 142 patients demonstrated that therapy with docetaxel plus epirubicin is highly active first-line therapy for metastatic breast cancer, with acceptable toxicity profile. Recently initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. 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. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population.

Enrollment

46 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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