Metastatic Breast CancerPhase 2NCT00632541
A Phase II Study of Bevacizumab + Sorafenib in Metastatic Breast Cancer
A Phase 2 study testing Sorafenib, Bevacizumab and Imaging in people with Metastatic Breast Cancer, run by Hoosier Cancer Research Network at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Sorafenib, Bevacizumab and Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2007to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Ireland Cancer Center - University Hospitals of Cleveland
Cleveland, Ohio, 44106
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202
Arnett Cancer Care
Lafayette, Indiana, 47904
Horizon Oncology Center
Lafayette, Indiana, 47905
Medical Consultants, P.C.
Muncie, Indiana, 47303
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
About this study
Official title: A Phase II Study of Combined VEGF Inhibitor (Bevacizumab + Sorafenib) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE06-109
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.
Read the detailed description
OUTLINE: This is a multi-center study.
Sorafenib 200mg po daily Bevacizumab 5mg/kg every other week
1 Cycle = 4 weeks Imaging every third cycle
Acceptable toxicity and non-PD = Protocol therapy will continue Un-acceptable toxicity or PD = Protocol therapy will be discontinued
ECOG Performance Status 0-1
Life Expectancy: at least 12 weeks
Hematopoietic:
- Platelets > 100 K/mm3
- Absolute neutrophil count (ANC) > 1.5 K/mm3
- Hemoglobin > 10 g/dL
Hepatic:
- Total Bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST, SGOT) < 2 x ULN (up to 5 x ULN in patients with known liver involvement)
Renal:
- Creatinine < 1.5 x ULN
- No proteinuria as demonstrated by either Urine protein:creatinine (UPC) ratio < 1.0 or Urine dipstick for proteinuria < 2+
Cardiovascular:
- No known myocardial infarction, unstable angina, > grade II New York Heart Association (NYHA) classification, congestive heart failure, uncontrolled hypertension defined as SBP >150 or DBP >100, > grade II peripheral vascular disease or significant vascular disease (e.g. aortic aneurysm, aortic dissection) within 12 months prior to being registered for protocol therapy.
- No uncontrolled or clinically significant arrhythmia. NOTE: Controlled atrial fibrillation is allowed.
- LVEF ≥ LLN by MUGA or ECHO as obtained within 28 days prior to being registered for protocol therapy.
Pulmonary:
- No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within 28 days prior to being registered for protocol therapy.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Sorafenib, Bevacizumab, Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Sorafenib 200mg po daily
BevacizumabDrug
Bevacizumab 5mg/kg every other week
1 Cycle = 4 weeks
ImagingOther
Imaging every third cycle
| Study group | Role | What they receive |
|---|---|---|
| Single Arm A | Experimental | Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle Receives: Drug: Sorafenib; Drug: Bevacizumab; Other: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Assess the Overall Response Rate.
Measured: 24 months
Determine the Adverse Event Profile of Sorafenib Combined With Bevacizumab in This Patient Population.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Significant Toxicities Experienced
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Bayer, Amgen
- Responsible party
- Principal investigator, Robin Zon, MD, Hoosier Cancer Research Network
- Investigators
- Robin T Zon, M.D., Principal investigator, Hoosier Oncology Group, Inc.Kathy Miller, M.D., Principal investigator, Hoosier Oncology Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632541
- Sponsor's protocol ID
- BRE06-109
- Status last verified
- Feb 2018
- First submitted
- 28 Feb 2008
- Last updated
- 14 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23812905
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Combined VEGF Inhibitor (Bevacizumab + Sorafenib) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE06-109
- ClinicalTrials.gov ID
- NCT00632541
- Acronym / sponsor ID
- BRE06-109
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Significant Toxicities Experienced
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Genentech, Inc., Bayer, Amgen
- Study start
- Oct 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Posted 7 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OUTLINE: This is a multi-center study.
Sorafenib 200mg po daily Bevacizumab 5mg/kg every other week
1 Cycle = 4 weeks Imaging every third cycle
Acceptable toxicity and non-PD = Protocol therapy will continue Un-acceptable toxicity or PD = Protocol therapy will be discontinued
ECOG Performance Status 0-1
Life Expectancy: at least 12 weeks
Hematopoietic:
- Platelets > 100 K/mm3
- Absolute neutrophil count (ANC) > 1.5 K/mm3
- Hemoglobin > 10 g/dL
Hepatic:
- Total Bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST, SGOT) < 2 x ULN (up to 5 x ULN in patients with known liver involvement)
Renal:
- Creatinine < 1.5 x ULN
- No proteinuria as demonstrated by either Urine protein:creatinine (UPC) ratio < 1.0 or Urine dipstick for proteinuria < 2+
Cardiovascular:
- No known myocardial infarction, unstable angina, > grade II New York Heart Association (NYHA) classification, congestive heart failure, uncontrolled hypertension defined as SBP >150 or DBP >100, > grade II peripheral vascular disease or significant vascular disease (e.g. aortic aneurysm, aortic dissection) within 12 months prior to being registered for protocol therapy.
- No uncontrolled or clinically significant arrhythmia. NOTE: Controlled atrial fibrillation is allowed.
- LVEF ≥ LLN by MUGA or ECHO as obtained within 28 days prior to being registered for protocol therapy.
Pulmonary:
- No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within 28 days prior to being registered for protocol therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm A | Experimental | Drug: Sorafenib, Drug: Bevacizumab, Other: ImagingSorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SorafenibSorafenib 200mg po daily | Drug | Single Arm A |
| BevacizumabBevacizumab 5mg/kg every other week 1 Cycle = 4 weeks | Drug | Single Arm A |
| ImagingImaging every third cycle | Other | Single Arm A |
Primary outcome
Progression-Free Survival
Time frame: From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months
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.
3 secondary outcomes
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.
Time frame: 6 months
Assess the Overall Response Rate.
Time frame: 24 months
Determine the Adverse Event Profile of Sorafenib Combined With Bevacizumab in This Patient Population.
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23812905Mina 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.
- Hoosier Cancer Research Network HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin T Zon, M.D. principal investigator
Hoosier Oncology Group, Inc.
Kathy Miller, M.D. principal investigator
Hoosier Oncology Group, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib, Bevacizumab and Imaging in people with Metastatic Breast Cancer, run by Hoosier Cancer Research Network at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00632541, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.