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

Metastatic Breast Cancer Clinical Trial

Official title:

A Multicenter, Phase II, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00434356
• Other study ID #: AVF4057g
• Status: Terminated
• Phase: Phase 2
• First received: February 9, 2007
• Last updated: November 17, 2009
• Start date: March 2007

Study information

• Verified date: November 2009
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• bevacizumab
Intravenous repeating dose
• sunitinib
Oral repeating dose
• paclitaxel
Intravenous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Response		From randomization until disease progression/recurrence (by patient)	No
Secondary	Serious Adverse Events (SAEs)		30 days following the last administration of study treatment	No
Secondary	Grade = 3 Adverse Events (AEs)		30 days following the last administration of study treatment	No
Secondary	Adverse Events Leading to Death		30 days following the last administration of study treatment	No
Secondary	Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction		30 days following the last administration of study treatment	No
Secondary	Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption		30 days following the last administration of study treatment	No