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

Breast Cancer Clinical Trial

Official title:

Docetaxel-epirubicin Plus Bevacizumab as First Line Therapy for Patients With Metastatic and HER2 Negative Breast Cancer. A Multicenter Phase I-II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705315
• Other study ID #: CT/07.21
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 24, 2008
• Last updated: August 18, 2010
• Start date: May 2008
• Est. completion date: June 2010

Study information

• Verified date: August 2010
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Docetaxel
Docetaxel as an IV infusion over 1h at the dose of 75mg/m2 every 3 weeks for 6 cycles
• Epirubicin
Epirubicin as an IV infusion over 10 min at the dose of 75mg/m2 every 3 weeks for 6 cycles
• Bevacizumab
Bevacizumab as an IV infusion over 1h at the dose of 15 mg/kg every 3 weeks for 6 cycles

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
Greece	"IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Athens
Greece	"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Athens
Greece	"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology	Athens
Greece	401 Military Hospital of Athens	Athens
Greece	Air Forces Military Hospital of Athens	Athens
Greece	University Hospital of Crete, Dep of Medical Oncology	Heraklion
Greece	State General Hospital of Larissa, Dep of Medical Oncology	Larissa,
Greece	"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology	Piraeus
Greece	"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate		Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)	No
Secondary	Toxicity assessment		Toxicity assessment on each cycle	Yes
Secondary	Time to Tumor Progression		1 year	No
Secondary	Overall Survival		1 year	No