Salvage Therapy With Bevacizumab Plus Docetaxel and Cisplatin for Taiwanese Metastatic Breast Cancer

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
• Normal left ventricular ejection fraction (LVEF).
• Age ≤ 65 years.
• At least one unidimensionally measurable lesion by imaging studies.
• AST/ALT 2.5 ULN (< 5 ULN if liver metastases).
• Serum bilirubin 3 ULN, Serum Creatinine 1.5 ULN.
• Urine dipstick of proteinuria <2+.
• Women of childbearing potential must have a negative serum pregnancy test.

Exclusion Criteria:

• Uncontrolled hypertension (systolic blood pressure > 160 mm Hg, diastolic blood pressure > 90 mm Hg).
• Prior exposure to bevacizumab.
• Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed), except bone metastasis.
• Evidence of bleeding diathesis or coagulopathy.
• Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. Stroke in the preceding six months.
• Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of bevacizumab with chemotherapy.
• Ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration.
• Pregnancy (positive serum pregnancy test) and lactation. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.