Docetaxel/Epirubicin/Bevacizumab as First Line Therapy for Metastatic HER2 Negative Breast Cancer - Full Text View

Sponsored by:	Hellenic Oncology Research Group
Information provided by:	Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00705315

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Docetaxel Drug: Epirubicin Drug: Bevacizumab	Phase I Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Bevacizumab Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:

Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity assessment [ Time Frame: Toxicity assessment on each cycle ] [ Designated as safety issue: Yes ]
Time to Tumor Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	46
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

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

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705315

Contacts

Contact: Dora Hatzidaki	+302810392570	dorachat@med@uoc.gr
Contact: Eva Maragkoudaki	+302810392857	dorachat@med.uoc.gr

Locations

Greece
University Hospital of Crete, Dep of Medical Oncology	Recruiting
Heraklion, Greece
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr
Sub-Investigator: Manolis Saloustros, MD
401 Military Hospital of Athens	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD 30-21-0644-8666 secretary@horg.gr
Contact: Spyros Georgiadis 30-21-0645-7968 secretary@horg.gr
Principal Investigator: Charalampos Christophillakis, MD
Air Forces Military Hospital of Athens	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD 30-21-0644-8666 secretary@horg.gr
Contact: Spyros Georgiadis 30-28-139-2857 secretary@horg.gr
Principal Investigator: Nikos Kentepozidis, MD
State General Hospital of Larissa, Dep of Medical Oncology	Recruiting
Larissa,, Greece
Contact: Nikoleta Karkatzou, MD 30-21-0644-8666 secretary@horg.gr
Contact: Spyros Georgiadis 30-21-0645-7968 secretary@horg.gr
Principal Investigator: Athanasios Athanasiadis, MD
University General Hospital of Alexandroupolis, Dep of Medical Oncology	Recruiting
Alexandroupolis, Greece
Contact: Dora Hatzidaki 30-28-1039-2570 dorachat@med.uoc.gr
Contact: Eva Maragkoudaki 30-28-1039-2857 dorachat@med.uoc.gr
Principal Investigator: Stelios Kakolyris, MD
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Recruiting
Thessaloniki, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Ioannis Mpoukobinas, MD
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Giassas, MD
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@med.uoc.gr
Contact: Spyros Georgiadis +302106457968 secretary@med.uoc.g
Principal Investigator: Aris Polyzos, MD
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology	Recruiting
Piraeus, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Ziras, MD
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Malamos, MD

Sponsors and Collaborators

Hellenic Oncology Research Group

Investigators

Principal Investigator:

Dimitris Mavrudis, MD

University Hospital of Crete, Dep of Medical Oncology

More Information

Responsible Party:	Hellenic Oncology Research Group ( Dimitris Mavrudis )
Study ID Numbers:	CT/07.21
Study First Received:	June 24, 2008
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00705315
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

breast cancer
chemotherapy
biological therapy

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Breast Neoplasms

Bevacizumab
Epirubicin
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Antibiotics, Antineoplastic
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009