- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00434356
A Study of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer (SABRE-B)
November 17, 2009 updated by: Genentech, Inc.
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Intravenous repeating dose
Intravenous repeating dose
Oral repeating dose
|
Placebo Comparator: 2
|
Intravenous repeating dose
Intravenous repeating dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best Response
Time Frame: From randomization until disease progression/recurrence (by patient)
|
The best overall response is the best response, per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses).
Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.
|
From randomization until disease progression/recurrence (by patient)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serious Adverse Events (SAEs)
Time Frame: 30 days following the last administration of study treatment
|
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0.
An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator
|
30 days following the last administration of study treatment
|
Grade ≥ 3 Adverse Events (AEs)
Time Frame: 30 days following the last administration of study treatment
|
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0.
Grading: 1=Mild AE; 2=Moderate AE; 3=Severe AE; 4=Life-threatening or disabling AE; 5=Death related to AE
|
30 days following the last administration of study treatment
|
Adverse Events Leading to Death
Time Frame: 30 days following the last administration of study treatment
|
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
|
30 days following the last administration of study treatment
|
Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Time Frame: 30 days following the last administration of study treatment
|
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
|
30 days following the last administration of study treatment
|
Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Time Frame: 30 days following the last administration of study treatment
|
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
|
30 days following the last administration of study treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jai Balkissoon, M.D., Genentech, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
February 9, 2007
First Submitted That Met QC Criteria
February 9, 2007
First Posted (Estimate)
February 13, 2007
Study Record Updates
Last Update Posted (Estimate)
December 3, 2009
Last Update Submitted That Met QC Criteria
November 17, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Paclitaxel
- Sunitinib
- Bevacizumab
Other Study ID Numbers
- AVF4057g
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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