Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital of Crete
• Treatments: Bevacizumab; Docetaxel; Gemcitabine

Criteria

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

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