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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 paclitaxel in patients who have not previously received chemotherapy for locally recurrent or metastatic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Paclitaxel; Sunitinib

Criteria

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