Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer

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.

Eligibility: 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

Relevance to patient case: not relevant