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

This study has been terminated.
(Based on data collected, the combination appeared to be poorly tolearated.)
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00434356
First received: February 9, 2007
Last updated: November 17, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: bevacizumab
Drug: sunitinib
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Best Response [ Time Frame: From randomization until disease progression/recurrence (by patient) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serious Adverse Events (SAEs) [ Time Frame: 30 days following the last administration of study treatment ] [ Designated as safety issue: No ]
  • Grade ≥ 3 Adverse Events (AEs) [ Time Frame: 30 days following the last administration of study treatment ] [ Designated as safety issue: No ]
  • Adverse Events Leading to Death [ Time Frame: 30 days following the last administration of study treatment ] [ Designated as safety issue: No ]
  • Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction [ Time Frame: 30 days following the last administration of study treatment ] [ Designated as safety issue: No ]
  • Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption [ Time Frame: 30 days following the last administration of study treatment ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: March 2007
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab
Intravenous repeating dose
Drug: sunitinib
Oral repeating dose
Drug: paclitaxel
Intravenous repeating dose
Placebo Comparator: 2 Drug: bevacizumab
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434356

Sponsors and Collaborators
Genentech
Investigators
Study Director: Jai Balkissoon, M.D. Genentech
  More Information

No publications provided

Responsible Party: Jai Balkissoon, M.D., Study Director, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00434356     History of Changes
Other Study ID Numbers: AVF4057g
Study First Received: February 9, 2007
Results First Received: September 1, 2009
Last Updated: November 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Avastin
MBC
Breast Cancer
Sutent

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Bevacizumab
Sunitinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014