Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Bevacizumab; Drug: Docetaxel; Drug: Gemcitabine

• Registration Number: NCT00754351
• Lead Sponsor: University Hospital of Crete

Brief Summary

This study will evaluate the efficacy and toxicity of docetaxel, gemcitabine and bevacizumab combination, administered biweekly, as salvage treatment in patients with metastatic and HER2 negative breast cancer.

Detailed Description

Docetaxel plus gemcitabine is an active combination in the salvage treatment for metastatic breast cancer. Administered every two weeks, this combination has a favorable toxicity profile, and promising activity in \> 1st line treatment for metastatic breast cancer. 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 addition of bevacizumab to a biweekly regimen of docetaxel and gemcitabine in the salvage therapy for metastatic breast cancer.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-17
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
• No HER2 overexpression or gene amplification
• At least one previous chemotherapy regimen for metastatic breast cancer
• Age ≥18 years
• Performance status (WHO) 0-2
• Life expectancy of at least 12 weeks
• Measurable disease as defined by at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm
• Performance status (WHO) 0-2
• Adequate liver function (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 upper normal limit in the presence of liver metastases), adequate renal function (serum creatinine <1.5 times the upper normal limit) and bone marrow ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 9 g/dL) function
• Written informed consent

Read More

Exclusion Criteria

• Pregnant or lactating women
• Progressive brain metastases according to clinical or radiological criteria
• Brain metastases without prior radiation therapy
• Radiation therapy within the previous 4 weeks
• Previous radiation therapy to the only measurable lesion
• Proteinuria ≥ 500 mgr of protein daily
• Uncontrolled hypertension
• Documented hemorrhagic diathesis or coagulation disorder
• Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF < normal, ventricular arrhythmia, uncontrolled hypertension)
• Thrombotic event within the previous 6 months
• Concurrent use of aspirin > 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents
• Major surgical procedure within the previous 4 weeks
• Presence of nonhealing wound or fracture
• Peripheral neuropathy > grade 2 according to the NCI CTCAE (version 3.0)
• Any sustained chronic toxicity > grade 2 according to the NCI CTCAE (version 3.0)
• Uncontrolled infection
• Any serious, uncontrolled comorbidity on the investigator's judgment
• Other cancer within the previous 5 years, except non-melanoma skin cancer and in situ cervical cancer
• Serious psychiatric illness

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Bevacizumab	Bevacizumab-\>Docetaxel-\>Gemcitabine
1	Docetaxel	Bevacizumab-\>Docetaxel-\>Gemcitabine
1	Gemcitabine	Bevacizumab-\>Docetaxel-\>Gemcitabine

Primary Outcome Measures

Name	Time	Method
Overall response rate	up to 6 months

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	1 year
Toxicity profile	21 days
Overall Survival	1 year
Quality of life assessment	Assessment every two cycles

Trial Locations

Locations (2)

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

University Hospital of Crete, Dep of Medical Oncology; 🇬🇷 Heraklion, Crete, Greece