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

NCT00705315 | Completed Phase 1

• 1 other identifier: CT/07.21
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Breast Cancer

Keywords

breast cancer; chemotherapy; biological therapy

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcomes (3)

• Toxicity assessment

  Toxicity assessment on each cycle

• Time to Tumor Progression

  1 year

• Overall Survival

  1 year

Study Arms (1)

1

EXPERIMENTAL

Bevacizumab-\>Epirubicin-\>Docetaxel

Drug: Docetaxel; Drug: Epirubicin; Drug: Bevacizumab

Interventions

Docetaxel DRUG

Docetaxel as an IV infusion over 1h at the dose of 75mg/m2 every 3 weeks for 6 cycles

Also known as: Taxotere

1

Epirubicin DRUG

Epirubicin as an IV infusion over 10 min at the dose of 75mg/m2 every 3 weeks for 6 cycles

Also known as: Farmorubicine

1

Bevacizumab DRUG

Bevacizumab as an IV infusion over 1h at the dose of 15 mg/kg every 3 weeks for 6 cycles

Also known as: Avastin

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead

Study Sites (10)

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Greece

Location

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

Related Publications (1)

• Tryfonidis K, Boukovinas I, Xenidis N, Christophyllakis C, Papakotoulas P, Politaki E, Malamos N, Polyzos A, Kakolyris S, Georgoulias V, Mavroudis D; Hellenic Oncology Research Group. A multicenter phase I-II study of docetaxel plus epirubicin plus bevacizumab as first-line treatment in women with HER2-negative metastatic breast cancer. Breast. 2013 Dec;22(6):1171-7. doi: 10.1016/j.breast.2013.08.017. Epub 2013 Oct 1.

  PMID: 24091128 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Epirubicin; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Dimitris Mavrudis, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 26, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 19, 2010

Record last verified: 2010-08

Locations

GR (10)