Breast CancerPhase 1/2NCT00095706
Treatment of HER2-Positive Metastatic Breast Cancer With Herceptin and Bevacizumab (Antibodies Against HER2 and VEGF)
A Phase 1/2 study testing Bevacizumab (drug), Herceptin (drug) in people with Breast Cancer, run by Translational Oncology Research International at 18 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of combined treatment with trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in patients with HER2-positive metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bevacizumab (drug), Herceptin (drug)
- How many people
- 50 participants
- Where
- 18 sitesUnited States
- Study dates
- Jun 2003to Jan 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic or relapsed locally advanced breast cancer
- HER2-positive by FISH
- No prior chemotherapy for metastatic disease
- ECOG performance status 0-2
- Normal left ventricular ejection fraction
- Bidimensionally measurable disease
- Oxygen saturation > 90% on room air
Who cannot join
- Other invasive malignancy within 5 years
- More than 3 different metastatic sites
- >50% liver involvement by metastasis
- Newly diagnosed untreated Stage IIIB breast cancer
- Prior chemotherapy for metastatic disease
- Clinically significant cardiovascular disease
Show all 16Show fewer
- History or evidence of CNS disease
- Major surgery within 28 days prior to day 0
- Current or recent use of parenteral anticoagulants
- WBC < 3,000/uL
- Platelet count < 75,000/uL
- Hemoglobin < 9.0 g/dL
- Total Bilirubin > 2.0 mg/dL
- AST or ALT > 5 time upper limit of normal for subjects with documented liver metastases; > 2.5 times upper limit of normal for subjects without evidence of liver metastases
- Proteinuria (> 1g protein/24 hours at baseline)
- Prior therapy with Herceptin or rhuMAb VEGF (bevacizumab)
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, 91801
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Virginia K. Crosson Cancer Center
Fullerton, California, 92835
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109
Suburban Hematology-Oncology Associates, P.A.
Lawrenceville, Georgia, 30045
Pacific Shores Medical Group
Long Beach, California, 90813
UCLA Medical Center
Los Angeles, California, 90095
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, 30060
North Valley Hematology/Oncology Medical Group
Northridge, California, 91328
Cancer Institute of Florida, P.A.
Orlando, Florida, 32804
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030
Oncology Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61615
Wilshire Oncology Medical Group, Inc.
Pomona, California, 91767
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, 93105
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105
San Diego Cancer Center
Vista, California, 92081
About this study
Official title: Phase I/II Combined Biological Therapy of Breast Cancer Using Monoclonal Antibodies Directed Against HER2/Neu Proto-Oncogene and Vascular Endothelial Growth Factor
The purpose of this study is to evaluate the safety and effectiveness of combined treatment with trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in patients with HER2-positive metastatic breast cancer.
Read the detailed description
Based on preclinical experiments conducted in our laboratories, we hypothesize that the aggressive behavior of HER2-overexpressing breast cancers is due in part to increased angiogenesis resulting from HER2-induced increases in vascular endothelial growth factor (VEGF) expression. In vivo experiments suggest that combined blockade of the HER2 receptor and VEGF results in superior anti-tumor efficacy compared with either treatment alone.
The current clinical trial, for which the phase I portion has been completed, will examine the efficacy and safety of trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in the treatment of HER2-overexpressing metastatic breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Bevacizumab (drug), Herceptin (drug)
- Keywords
- Metastatic breast cancer, HER2, Trastuzumab, Herceptin, VEGF, Bevacizumab, Avastin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab (drug), Herceptin (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the maximum tolerated dose (MTD) or recommended phase II dose of rhuMAb VEGF (bevacizumab) administered intravenously every 14 days to patients with HER2-amplified relapsed or metastatic breast cancer receiving concomitant Herceptin therapy
Secondary outcomes (3)
To evaluate the clinical safety and toxicities of rhuMAb VEGF when administered in combination with Herceptin
To characterize the pharmacokinetics of rhuMAb VEGF and Herceptin given in combination
To evaluate the efficacy of rhuMAb VEGF plus Herceptin in terms of clinical activity when administered as an intravenous infusion, in patients with previously untreated metastatic or relapsed breast cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2004 (estimated)
- Study startJun 2003
- Primary completionApr 2007
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Translational Oncology Research International
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Mark D Pegram, MD, Principal investigator, University of California, Los AngelesFairooz Kabbinavar, MD, Study chair, Chief Medical Officer, TORI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095706
- Sponsor's protocol ID
- TORI B-03
- Other IDs
- Western IRB #20041069, UCLA IRB #01-09-030
- Status last verified
- Sep 2015
- First submitted
- 5 Nov 2004
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Combined Biological Therapy of Breast Cancer Using Monoclonal Antibodies Directed Against HER2/Neu Proto-Oncogene and Vascular Endothelial Growth Factor
- ClinicalTrials.gov ID
- NCT00095706
- Acronym / sponsor ID
- TORI B-03
- Conditions
- Breast Cancer
- Keywords
- Metastatic breast cancer, HER2, Trastuzumab, Herceptin, VEGF, Bevacizumab, Avastin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Translational Oncology Research InternationalUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jun 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of combined treatment with trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in patients with HER2-positive metastatic breast cancer.
Detailed description
Based on preclinical experiments conducted in our laboratories, we hypothesize that the aggressive behavior of HER2-overexpressing breast cancers is due in part to increased angiogenesis resulting from HER2-induced increases in vascular endothelial growth factor (VEGF) expression. In vivo experiments suggest that combined blockade of the HER2 receptor and VEGF results in superior anti-tumor efficacy compared with either treatment alone.
The current clinical trial, for which the phase I portion has been completed, will examine the efficacy and safety of trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in the treatment of HER2-overexpressing metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Metastatic or relapsed locally advanced breast cancer
- HER2-positive by FISH
- No prior chemotherapy for metastatic disease
- ECOG performance status 0-2
- Normal left ventricular ejection fraction
Key exclusion criteria (16 listed)
- Other invasive malignancy within 5 years
- More than 3 different metastatic sites
- >50% liver involvement by metastasis
- Newly diagnosed untreated Stage IIIB breast cancer
- Prior chemotherapy for metastatic disease
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 |
|---|---|---|
| Bevacizumab (drug), Herceptin (drug) | Drug | – |
Primary outcome
To establish the maximum tolerated dose (MTD) or recommended phase II dose of rhuMAb VEGF (bevacizumab) administered intravenously every 14 days to patients with HER2-amplified relapsed or metastatic breast cancer receiving concomitant Herceptin therapy
3 secondary outcomes
To evaluate the clinical safety and toxicities of rhuMAb VEGF when administered in combination with Herceptin
To characterize the pharmacokinetics of rhuMAb VEGF and Herceptin given in combination
To evaluate the efficacy of rhuMAb VEGF plus Herceptin in terms of clinical activity when administered as an intravenous infusion, in patients with previously untreated metastatic or relapsed breast cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
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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.
Mark D Pegram, MD principal investigator
University of California, Los Angeles
Fairooz Kabbinavar, MD study chair
Chief Medical Officer, TORI
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bevacizumab (drug), Herceptin (drug) in people with Breast Cancer, run by Translational Oncology Research International at 18 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 7 inclusion and 16 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: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To establish the maximum tolerated dose (MTD) or recommended phase II dose of rhuMAb VEGF (bevacizumab) administered intravenously every 14 days to patients with HER2-amplified relapsed or metastatic breast cancer receiving concomitant Herceptin therapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2015.