Breast CancerPhase 2NCT00670982
Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer
A Phase 2 study testing bevacizumab, vinorelbine and trastuzumab in people with Breast Cancer, run by Harold J. Burstein, MD, PhD at 7 sites in United States.
Trial summary
The purpose of this research study is to determine the effects of the combination of bevacizumab, vinorelbine, and trastuzumab on participants and their cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- bevacizumab, vinorelbine and trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2008to Dec 2012
- 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
- Histologically or cytologically confirmed invasive breast cancer, with metastatic disease.
- HER2-positive tumor
- Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension as 20mm or greater with conventional techniques or as 10mm or greater with spiral CT scan
- 18 years of age or older
- Life expectancy of more than 12 weeks
- ECOG Performance Status of 0 or 1
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- Normal organ and marrow function as outlined in the protocol
- Left ventricular ejection fraction 50% or greater as determined by RVG or echocardiogram within 30 days prior to initiation of protocol therapy
- Patients with stable or previously treated CNS metastases are eligible for study participation, provided there is no history of clinically significant CNS bleeding
- Men and women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation
- COHORT A:
- No prior chemotherapy for treatment of metastatic breast cancer
- May NOT have received prior treatment with trastuzumab for recurrent or metastatic breast cancer
- No prior vinorelbine for treatment of breast cancer
- No prior bevacizumab for treatment of breast cancer
- May have received prior radiation therapy and/or any number of lines of hormonal therapy
- Prior trastuzumab therapy in the adjuvant setting is also allowed, providing that relapse occured at least 12 months following the last dose
- Must have recovered from all reversible toxicities related to prior therapy and may not have any pre-existing treatment-related toxicities in excess of Grade 1. Patients must have stopped prior radiation therapy at least 7 days prior to beginning protocol treatment
- COHORT B:
- One prior line of chemotherapy for treatment of metastatic breast cancer or recurrence of breast cancer within 12 months of completion of adjuvant trastuzumab
- No prior vinorelbine for treatment of breast cancer
- No prior bevacizumab for treatment of breast cancer
- May have received prior radiation therapy and/or any number of lines of hormonal therapy
- Must have recovered from all reversible toxicities related to prior therapy and may not have any pre-existing treatment-related toxicities in excess of Grade 1. Patients must have stopped prior radiation therapy at least 7 days prior to beginning protocol treatment
Who cannot join
- Patients who have had chemotherapy within 14 days prior to entering the study, ot those who have not recovered adequately from adverse events due to agents administered earlier
- Concurrent radiation therapy
- History of Grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition as the agents used in this study
- Prior therapy with bevacizumab or vinorelbine
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
- Inadequately controlled hypertension
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- Prior history of hypertensive crisis of hypertensive encephalopathy
- NHYA Grade II or greater congestive heart failure
- History of myocardial infarction of unstable angina within 6 months prior to study enrollment
- History of stroke or transient ischemic attack within 6 months prior to study enrollment
- Progressive or untreated CNS metastases
- Significant vascular disease within 6 months prior to study enrollment
- Symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of vascular access device, within 7 days prior to study enrollment
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Serious non-healing wound, active ulcer, or untreated bone fracture
- Proteinuria at screening
- Pregnant or lactating
- Current and ongoing treatment with full-dose warfarin or its equivalent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Faulkner Hospital
Boston, Massachusetts, 02130
Hartford Hospital
Hartford, Connecticut, 06101
New Hampshire Oncology-Hematology PA
Hooksett, New Hampshire, 03106
Lowell General Hospital
Lowell, Massachusetts, 01850
About this study
Official title: Phase 2 Study of Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer
The purpose of this research study is to determine the effects of the combination of bevacizumab, vinorelbine, and trastuzumab on participants and their cancer.
Read the detailed description
- Participants will receive bevacizumab intravenously every 2 weeks. They will also receive trastuzumab and vinorelbine intravenously once a week. Therefore, treatments will alternate between receiving all three drugs (1st week, third week, fifth week, etc.) and receiving only trastuzumab and vinorelbine (2nd week, fourth week, sixth week, etc.) A treatment cycle lasts four weeks.
- During all treatment cycles a physical exam will be performed and the participant will be asked general health and specific questions about any problems they are experiencing.
- X-ray, CT scans, and/or MRI scans will be performed every 8 weeks (every 2 cycles) in order to assess the effect of the study treatment on the participants cancer. These tests are considered standard of care in patients receiving chemotherapy.
- Once a week blood counts will be performed and at least every 4 weeks, chemistry and other tests to measure any additional effect of the study drug and disease status will be checked. These tests are also considered standard of care for patients receiving chemotherapy.
- At the beginning of the study and at the 4- and 8-week time point, additional blood will be drawn in order to conduct research blood tests to measure the presence of cancer cells in the blood.
- A urine test and MUGA scan or echocardiogram will be done every 8 weeks while the participant in on the study.
- Participants can remain on the research study as long as the study treatment appears to be working and they are not experiencing unacceptable side effects.
- Conditions
- Breast Cancer
- Being tested
- bevacizumab, vinorelbine, trastuzumab
- Keywords
- HER2 positive, bevacizumab, vinorelbine, trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
Also called Avastin
Given intravenously every 2 weeks
vinorelbineDrug
Also called Navelbine
Given intravenously once a week
trastuzumabDrug
Also called Herceptin
Given intravenously once a week
| Study group | Role | What they receive |
|---|---|---|
| First line treatment | Experimental | Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week Receives: Drug: bevacizumab; Drug: vinorelbine; Drug: trastuzumab |
| Second line treatment | Experimental | Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week. Receives: Drug: bevacizumab; Drug: vinorelbine; Drug: trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.
Percentage of patients on study without progression at one year after first treatment on study.The date of progression was defined as the earliest occurence of any of the following events: progressive disease by RECIST v1.0, date of initiation of new anticancer therapy, or death due to any cause. New anticancer therapy was defined as the addition or initiation of any new agent for treatment of cancer not including trastuzumab, vinorelbine or bevacizumab.
Measured: 1 year
Secondary outcomes (2)
Objective Response Rate
Objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) and assessed by computed tomography.Complete response (CR), disappearance of all target and non-target lesions; partial response (PR), >/=30% decrease in the sum of longest dimensions of target lesions; objective response rate = CR + PR.
Measured: 1 year
Progression-free Survival
Median progression free survival measured in months
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2011
- Study completionDec 2012
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harold J. Burstein, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Genentech, Inc., New Hampshire Oncology-Hematology PA, Lowell General Hospital, Hartford Hospital
- Responsible party
- Sponsor-investigator, Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Harold J. Burstein, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670982
- Sponsor's protocol ID
- 07-214
- Status last verified
- Mar 2013
- First submitted
- 29 Apr 2008
- Last updated
- 13 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00670982
- Acronym / sponsor ID
- 07-214
- Conditions
- Breast Cancer
- Keywords
- HER2 positive, bevacizumab, vinorelbine, trastuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Harold J. Burstein, MD, PhDUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Genentech, Inc., New Hampshire Oncology-Hematology PA, Lowell General Hospital, Hartford Hospital
- Study start
- May 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 May 2008 (estimated)
- Results
- Posted 13 May 2013
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 research study is to determine the effects of the combination of bevacizumab, vinorelbine, and trastuzumab on participants and their cancer.
Detailed description
- Participants will receive bevacizumab intravenously every 2 weeks. They will also receive trastuzumab and vinorelbine intravenously once a week. Therefore, treatments will alternate between receiving all three drugs (1st week, third week, fifth week, etc.) and receiving only trastuzumab and vinorelbine (2nd week, fourth week, sixth week, etc.) A treatment cycle lasts four weeks.
- During all treatment cycles a physical exam will be performed and the participant will be asked general health and specific questions about any problems they are experiencing.
- X-ray, CT scans, and/or MRI scans will be performed every 8 weeks (every 2 cycles) in order to assess the effect of the study treatment on the participants cancer. These tests are considered standard of care in patients receiving chemotherapy.
- Once a week blood counts will be performed and at least every 4 weeks, chemistry and other tests to measure any additional effect of the study drug and disease status will be checked. These tests are also considered standard of care for patients receiving chemotherapy.
- At the beginning of the study and at the 4- and 8-week time point, additional blood will be drawn in order to conduct research blood tests to measure the presence of cancer cells in the blood.
- A urine test and MUGA scan or echocardiogram will be done every 8 weeks while the participant in on the study.
- Participants can remain on the research study as long as the study treatment appears to be working and they are not experiencing unacceptable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First line treatment | Experimental | Drug: bevacizumab, Drug: vinorelbine, Drug: trastuzumabPatients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week |
| Second line treatment | Experimental | Drug: bevacizumab, Drug: vinorelbine, Drug: trastuzumabPatients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Histologically or cytologically confirmed invasive breast cancer, with metastatic disease.
- HER2-positive tumor
- Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension as 20mm or greater with conventional techniques or as 10mm or greater with spiral CT scan
- 18 years of age or older
- Life expectancy of more than 12 weeks
Key exclusion criteria (21 listed)
- Patients who have had chemotherapy within 14 days prior to entering the study, ot those who have not recovered adequately from adverse events due to agents administered earlier
- Concurrent radiation therapy
- History of Grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition as the agents used in this study
- Prior therapy with bevacizumab or vinorelbine
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
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 |
|---|---|---|
| bevacizumabAlso: AvastinGiven intravenously every 2 weeks | Drug | First line treatment, Second line treatment |
| vinorelbineAlso: NavelbineGiven intravenously once a week | Drug | First line treatment, Second line treatment |
| trastuzumabAlso: HerceptinGiven intravenously once a week | Drug | First line treatment, Second line treatment |
Primary outcome
Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.
Time frame: 1 year
Percentage of patients on study without progression at one year after first treatment on study.The date of progression was defined as the earliest occurence of any of the following events: progressive disease by RECIST v1.0, date of initiation of new anticancer therapy, or death due to any cause. New anticancer therapy was defined as the addition or initiation of any new agent for treatment of cancer not including trastuzumab, vinorelbine or bevacizumab.
2 secondary outcomes
Objective Response Rate
Time frame: 1 year
Progression-free Survival
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Harold J. Burstein, MD, PhD principal investigator
Dana-Farber Cancer Institute
7 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 bevacizumab, vinorelbine and trastuzumab in people with Breast Cancer, run by Harold J. Burstein, MD, PhD at 7 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 24 inclusion and 21 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 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 13 May 2013). 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?
Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy. (time frame: 1 year). 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 13 May 2013.