Status:
TERMINATED
A Study of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer (SABRE-B)
Lead Sponsor:
Genentech, Inc.
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multicenter, Phase II, randomized, controlled, open label trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with bevacizumab and paclit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00434356
Start Date
March 1 2007
Last Update
December 3 2009
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.