Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00754351
• Date of registration: 17/09/2008
• Prospective Registration: No
• Primary sponsor: University Hospital of Crete
• Public title: Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer
• Scientific title: Docetaxel, Gemcitabine and Bevacizumab as Salvage Therapy for Metastatic Breast Cancer
• Date of first enrolment: September 2008
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00754351
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Greece

Contacts

• Name: Dimitris Mavrudis, MD
• Affiliation: University Hospital of Crete, Dep of Medical Oncology

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Gemcitabine

Drug: Bevacizumab

Drug: Docetaxel

Primary Outcome(s)

Overall response rate [Time Frame: up to 6 months]

Secondary Outcome(s)

Toxicity profile [Time Frame: 21 days]

Overall Survival [Time Frame: 1 year]

Quality of life assessment [Time Frame: Assessment every two cycles]

Progression Free Survival [Time Frame: 1 year]

Secondary ID(s)

CT/08.01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors