A Phase II Study of Bevacizumab + Sorafenib in Metastatic Breast Cancer

NCT00632541 | Terminated Phase 2 Results DMC

• 1 other identifier: BRE06-109
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 10

Brief Summary

Prior clinical trials involving bevacizumab and sorafenib have demonstrated single agent activity in previously treated advanced breast cancer. This trial will test combined VEGF inhibition with sorafenib and bevacizumab in less heavily pre-treated patients with advanced breast cancer.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  The primary objective was to assess the Progression-Free Survival of sorafenib combined with bevacizumab in patients with metastatic breast cancer. Progression is defined by RECIST as a 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion.

  From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months

Secondary Outcomes (3)

• Assess the Clinical Benefit Response: the Proportion of Patients With Clinical Benefit (CR+PR+SD > 6 Months Duration) Will be Assessed at the Completion of the Study.

  6 months

• Assess the Overall Response Rate.

  24 months

• Determine the Adverse Event Profile of Sorafenib Combined With Bevacizumab in This Patient Population.

  24 months

Study Arms (1)

Single Arm A

EXPERIMENTAL

Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle

Drug: Sorafenib; Drug: Bevacizumab; Other: Imaging

Interventions

Sorafenib DRUG

Sorafenib 200mg po daily

Single Arm A

Bevacizumab DRUG

Bevacizumab 5mg/kg every other week 1 Cycle = 4 weeks

Single Arm A

Imaging OTHER

Imaging every third cycle

Single Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic or cytologic diagnosis of breast cancer with evidence of metastatic disease. NOTE: Patients with Her-2 positive (3+ by IHC or gene amplification by FISH) are eligible only if they have had prior trastuzumab therapy.
• Must have measurable or non-measurable lesions as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
• Two or fewer prior chemotherapy regimens in any disease setting. NOTE: All adjuvant and neoadjuvant chemotherapy will be considered one regimen. NOTE: Prior hormonal therapy for metastatic disease is allowed. NOTE: Prior radiation therapy is allowed as long as the irradiated area is not the only source of evaluable disease.
• Age \> 18 years at the time of consent.
• Written informed consent and HIPAA authorization for release of personal health information.
• Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 8 weeks after treatment discontinuation.
• Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
• Ability to comply with study and/or follow-up procedures.

You may not qualify if:

• No prior therapy with bevacizumab, sorafenib or any other known VEGF inhibitors.
• No known hypersensitivity to any component of the study drugs.
• No other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to being registered for protocol therapy.
• No history or radiologic evidence of CNS metastases including previously treated, resected, or asymptomatic brain lesions or leptominigeal involvement. A head CT or MRI must be obtained within 28 days prior to being registered for protocol therapy.
• No other participation in another clinical drug study within 28 days prior to being registered for protocol therapy.
• No known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C
• No major surgical procedure within 28 days prior to being registered for protocol therapy or anticipation of need for major surgical procedure during the course of the study. Placement of a vascular access device and breast biopsy will not be considered major surgery.
• No minor surgical procedure within 7 days prior to being registered for protocol therapy.
• No known history of cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage.
• No known history of ischemic bowel.
• No known history of deep venous thrombosis or pulmonary embolism.
• No history of hypertensive crisis or hypertensive encephalopathy.
• No non-healing wound or fracture.
• No active infection requiring parenteral antibiotics.
• No other hemorrhage/bleeding event ≥ CTCAE grade 3 within 28 days prior to being registered for protocol therapy.

Sponsors & Collaborators

• Hoosier Cancer Research Network: lead
• Genentech, Inc.: collaborator
• Bayer: collaborator
• Amgen: collaborator

Study Sites (10)

Medical & Surgical Specialists, LLC

Galesburg, Illinois, 61401, United States

Location

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, 47714, United States

Location

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, 46815, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Quality Cancer Center (MCGOP)

Indianapolis, Indiana, 46202, United States

Location

Arnett Cancer Care

Lafayette, Indiana, 47904, United States

Location

Horizon Oncology Center

Lafayette, Indiana, 47905, United States

Location

Medical Consultants, P.C.

Muncie, Indiana, 47303, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Ireland Cancer Center - University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Mina LA, Yu M, Johnson C, Burkhardt C, Miller KD, Zon R. A phase II study of combined VEGF inhibitor (bevacizumab+sorafenib) in patients with metastatic breast cancer: Hoosier Oncology Group Study BRE06-109. Invest New Drugs. 2013 Oct;31(5):1307-10. doi: 10.1007/s10637-013-9976-1. Epub 2013 Jun 28.

  PMID: 23812905 RESULT

Related Links

• Hoosier Cancer Research Network Homepage

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sorafenib; Bevacizumab; X-Rays

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Limitations and Caveats

The study was terminated early due to a poor safety profile as well as the lack of significant efficacy of this combination over bevacizumab alone in the short followup period where it was evaluated. Therefore, secondary objectives were not analyzed.

Results Point of Contact

• Title: Jeff Smith
• Organization: Hoosier Cancer Research Network

jsmith@hoosiercancer.org

317-634-5842

Study Officials

• Robin T Zon, M.D.

  Hoosier Oncology Group, Inc.

  PRINCIPAL INVESTIGATOR

• Kathy Miller, M.D.

  Hoosier Oncology Group, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 10, 2008
• Study Start: October 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: February 14, 2018
• Results First Posted: January 7, 2016

Record last verified: 2018-02

Locations

US (10)