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Male Breast CancerPhase 2NCT00017394

Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer

A Phase 2 study testing bevacizumab, vinorelbine tartrate and laboratory biomarker analysis in people with Male Breast Cancer and Recurrent Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase II trial to study the effectiveness of bevacizumab combined with vinorelbine in treating patients who have stage IV breast cancer. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bevacizumab, vinorelbine tartrate and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
Mar 2001to Sep 2007
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed stage IV breast cancer
  • Patients without pathologic or cytologic confirmation of metastatic disease must have unequivocal evidence of metastasis by physical exam or radiologic study
  • Must meet 1 of the following criteria:
  • Received 1 or 2 prior conventional chemotherapy regimens for metastatic disease
  • Relapsed within 1 year after adjuvant chemotherapy and no prior chemotherapy for metastatic disease
  • At least 1 unidimensionally measurable lesion, meeting 1 of the following criteria:
Show all 78Show fewer
  • At least 20 mm by conventional techniques
  • At least 10 mm by spiral CT scan
  • No CNS metastases by CT scan or MRI within the past 6 weeks
  • No prior or concurrent primary CNS tumor on physical exam
  • Disease progression after bone marrow or peripheral blood stem cell transplantation allowed
  • HER2-positive tumors allowed if previously treated with trastuzumab (Herceptin)
  • Hormone receptor status:
  • Not specified
  • Male or female
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 3 months
  • Absolute neutrophil count at least 1,500/mm^3
  • Hemoglobin at least 9 g/dL
  • Platelet count at least 100,000/mm^3
  • No prior bleeding diathesis or coagulopathy
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN
  • INR no greater than 1.5
  • Creatinine less than 2 mg/dL
  • Urine protein no greater than +1 by dipstick
  • Urine protein less than 500 mg by 24-hour urine collection
  • LVEF at least 50%
  • No prior stroke
  • No New York Heart Association class II-IV congestive heart failure
  • No serious cardiac arrhythmia requiring medication, including atrial fibrillation requiring systemic anticoagulation
  • No grade II or greater peripheral vascular disease within the past year
  • No clinically significant peripheral artery disease
  • No deep vein thrombosis or embolism within the past 5 years
  • No arterial thromboembolic event within the past 6 months, including any of the following:
  • Transient ischemic attack
  • Cerebrovascular accident
  • Unstable angina
  • Myocardial infarction
  • No other significant cardiovascular disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No evidence of seizures not controlled with standard medical therapy
  • No prior allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in the study
  • Prior mild infusion reaction to trastuzumab allowed
  • No serious non-healing wound, ulcer, or bone fracture
  • No significant traumatic injury within the past 4 weeks
  • No other concurrent illness (such as active infection) that would require active treatment or preclude study
  • No psychiatric illness or social situation that would preclude study
  • See Disease Characteristics
  • No prior bevacizumab
  • No other prior experimental angiogenesis inhibitors
  • At least 2 weeks since prior trastuzumab and recovered
  • Concurrent epoetin alfa or filgrastim (G-CSF) allowed
  • See Disease Characteristics
  • At least 2 weeks since prior chemotherapy and recovered
  • No prior vinorelbine
  • No more than 2 prior conventional chemotherapy regimens for metastatic breast cancer
  • Prior hormonal therapy allowed
  • At least 1 week since prior radiotherapy and recovered
  • No concurrent radiotherapy
  • At least 4 weeks since prior major surgical procedure or open biopsy
  • At least 1 week since prior fine-needle aspiration except in the breast
  • No concurrent major surgical procedure
  • Recovered from the toxic effects of any prior therapy
  • At least 10 days since prior oral or parenteral anticoagulants (e.g., heparin or warfarin) except to maintain the patency of permanent, indwelling central venous catheter
  • At least 10 days since prior thrombolytic agents
  • No chronic aspirin therapy greater than 325 mg per day or non-steroidal anti-inflammatory medications that inhibit platelet function
  • No concurrent COX-2 inhibitors that inhibit platelet function
  • No other concurrent investigational or commercial agents or therapies for the malignancy
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No concurrent ketoconazole, zidovudine, or macrolide antibiotics
  • No concurrent oral or parenteral anticoagulants except to maintain patency of permanent, indwelling central venous catheter
  • No concurrent thrombolytic agent
  • Concurrent bisphosphonates allowed
  • Concurrent celecoxib or rofecoxib allowed

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: A Phase II Study of Bevacizumab in Combination With Vinorelbine in Stage IV Breast Cancer

Phase II trial to study the effectiveness of bevacizumab combined with vinorelbine in treating patients who have stage IV breast cancer. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody with chemotherapy may kill more cancer cells

Read the detailed description

OBJECTIVES:

  1. Determine the complete and partial response rates in patients with stage IV breast cancer treated with concurrent bevacizumab and vinorelbine.

II. Determine the side effects of this regimen in these patients. III. Determine the time to disease progression in patients treated with this regimen.

IV. Determine the time on study (a reflection of time to progression, treatment-related side effects, and patient preference) of patients treated with this regimen.

  1. Assess urine protein/creatinine ratio and serum complement levels as screening measures for renal injury in patients treated with bevacizumab.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes once every other week and vinorelbine IV over 6-10 minutes once weekly for 8 weeks. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease after completion of the fourth course may receive additional courses of concurrent bevacizumab and vinorelbine administered once every other week or may continue therapy on the schedule as above.

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within 1 year.

Being tested
bevacizumab, vinorelbine tartrate, laboratory biomarker analysis
Medical subject headings
Breast Neoplasms, Male, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

  • vinorelbine tartrateDrug

    Also called Eunades, navelbine ditartrate, NVB, VNB

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00017394
Study groupRoleWhat they receive
Treatment (bevacizumab, vinorelbine tartrate)ExperimentalPatients receive bevacizumab IV over 30-90 minutes once every other week and vinorelbine IV over 6-10 minutes once weekly for 8 weeks. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease after completion of the fourth course may receive additional courses of concurrent bevacizumab and vinorelbine administered once every other week or may continue therapy on the schedule as above.
Receives: Biological: bevacizumab; Drug: vinorelbine tartrate; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate to combination therapy with bevacizumab and vinorelbine, defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria

    Measured: Up to 6 years

Secondary outcomes (2)

  1. Time to progression

    Measured: Time from the first treatment on study until the time of documented disease progression, assessed up to 6 years

  2. Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

    Measured: Up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2003 (estimated)
  2. Study startMar 2001
  3. Primary completionSep 2007

Resources

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
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00017394
Sponsor's protocol ID
NCI-2012-02388
Other IDs
01-013, CDR0000068685
Status last verified
Jan 2013
First submitted
6 Jun 2001
Last updated
17 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, vinorelbine tartrate and laboratory biomarker analysis in people with Male Breast Cancer and Recurrent Breast Cancer, run by National Cancer Institute (NCI) at 1 site 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 78 inclusion and 0 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 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

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?

Response rate to combination therapy with bevacizumab and vinorelbine, defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (time frame: Up to 6 years). 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 NCT00017394.

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 17 Jan 2013.

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