A Study of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer (SABRE-B)

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Avastin, MBC, Breast Cancer, Sutent Read More

Inclusion Criteria:

• Signed Informed Consent Form
• Histologically or cytologically confirmed adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease
• Age ≥ 18 years
• Adequate left ventricular function at study entry, defined as an Left Ventricular Ejection Fraction (LVEF) > 50% by either Multi Gated Acquisition(MUGA) scan or Electrocardiogram (ECHO)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Ability and willingness to comply with study and follow-up procedures

Exclusion Criteria:

• Unknown HER2 status or known HER2-positive status
• Prior chemotherapy for locally recurrent or metastatic disease
• Prior hormonal therapy within 2 weeks prior to Day 1
• Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior to Day 1
• Prior adjuvant or neoadjuvant non-taxane chemotherapy within 6 months prior to Day 1
• For patients who have received recent radiotherapy, ongoing Grade ≥ 3 acute toxicity
• Patients with brain metastasis on full dose anticoagulation therapy
• Life expectancy of < 12 weeks
• Current, recent (within 4 weeks of Day 1), or planned participation in an experimental drug study
• Inadequate organ function within 28 days prior to Day 1
• Untreated abnormal thyroid function tests
• Uncontrolled serious medical or psychiatric illness
• Active infection requiring IV antibiotics at enrollment or randomization
• History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
• Inadequately controlled hypertension
• Prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association (NYHA) Class II or greater CHF
• History of myocardial infarction or unstable angina within 12 months prior to Day 1
• History of stroke or transient ischemic attack within 12 months prior to Day 1
• Known central nervous system (CNS) disease except for treated brain metastasis
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 1
• History of hemoptysis within 1 month prior to Day 1
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
• History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
• Serious, non-healing wound, active ulcer, or untreated bone fracture
• Proteinuria at screening, as demonstrated by a urine protein/creatinine ratio of ≥ 1.0 at screening
• Known hypersensitivity to any component of bevacizumab or sunitinib
• Pregnancy (positive pregnancy test) or lactation