Breast Cancer
Conditions
Keywords
docetaxel, gemcitabine, bevacizumab, chemotherapy
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.
Interventions
DRUGBevacizumab
Bevacizumab (IV) 10 mgr/Kgr on days 1 and 15 every 4 weeks for 6 cycles followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression
DRUGDocetaxel
Docetaxel (IV) 65 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
DRUGGemcitabine
Gemcitabine (IV) 1500 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
Sponsors
University Hospital of Crete
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 1 year |
| Toxicity profile | 21 days |
| Overall Survival | 1 year |
| Quality of life assessment | Assessment every two cycles |
Countries
Greece
Outcome results
None listed