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Metastatic Breast CancerPhase 2NCT00369655

VEGF Trap in Treating Patients With Metastatic Breast Cancer

A Phase 2 study testing ziv-aflibercept in people with Metastatic 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

This phase II trial is studying how well VEGF Trap works in treating patients with metastatic breast cancer. VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ziv-aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
Jan 2007to Jan 2011
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 adenocarcinoma of the breast
  • Clinical evidence of metastatic disease
  • No more than 2 prior chemotherapy regimens for metastatic disease
  • Prior neoadjuvant or adjuvant chemotherapy allowed*
  • At least 1 prior regimen (in any setting) must have included a taxane and/or an anthracycline
  • Measurable disease, defined as ≥ 1 lesion whose longest diameter can be accurately measured per RECIST criteria
Show all 70Show fewer
  • No nonmeasurable disease, defined as all other lesions, including small lesions(longest diameter < 20 mm) and truly nonmeasurable lesions, including the following:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Inflammatory breast disease
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • Patients with HER2-positive tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization [FISH]) must have received ≥ 1 prior trastuzumab (Herceptin®)-containing regimen in either the adjuvant or metastatic setting, unless there was a contraindication
  • No known CNS metastases
  • No evidence of leptomeningeal involvement
  • Hormone receptor status not specified
  • Male or female
  • Menopausal status not specified
  • ECOG performance status 0-1
  • Life expectancy > 3 months
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin > 8.0 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • AST and ALT ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Urine protein:creatinine ratio < 1 OR urine protein < 500 mg by 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • No significant traumatic injury within the past 4 weeks
  • No history of allergy or hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies, drug product excipients, or agents chemically or biologically similar to VEGF Trap
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No nonhealing wound, fracture, or ulcer
  • No stage III or IV invasive, nonbreast malignancy within the past 5 years
  • No history of lung carcinoma of squamous cell type
  • No clinically significant cardiovascular disease, including any of the following:
  • Cerebrovascular accident or stroke within the past 6 months
  • Uncontrolled hypertension, defined as blood pressure (BP) > 150/100 mm Hg OR systolic BP > 180 mm Hg if diastolic blood pressure < 90 mm Hg on ≥ 2 separate occasions within the past 3 months
  • Myocardial infarction, coronary artery bypass graft, or unstable angina within the past 6 months
  • New York Heart Association class III or IV cardiovascular disease
  • Serious cardiac arrhythmia requiring medication
  • Peripheral vascular disease ≥ grade 2 within the past 6 months
  • Pulmonary embolism, deep vein thrombosis, or other thromboembolic event within the past 6 months
  • No evidence of bleeding diathesis or uncontrolled coagulopathy
  • No active, unresolved infection
  • No serious concurrent medical condition that would preclude study participation
  • No other condition or circumstance that would preclude compliance with study requirements
  • See Disease Characteristics
  • Prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting allowed
  • No prior bevacizumab
  • More than 4 weeks since prior chemotherapy, endocrine therapy, experimental drug therapy, or immunotherapy and recovered
  • More than 4 weeks since prior major surgery or open biopsy
  • More than 7 days since prior core biopsy
  • More than 2 weeks since prior radiotherapy, except if to a nontarget lesion only
  • Prior radiotherapy to a target lesion allowed only if there has been clear progression of the lesion since radiotherapy was completed
  • Prior single-dose palliative radiotherapy within the past 2 weeks allowed
  • No concurrent major surgery
  • No concurrent trastuzumab
  • Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR > 1.5 allowed provided the following criteria are met:
  • INR in-range (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
  • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent participation in another investigational clinical trial
  • No other concurrent chemotherapeutic agents, endocrine therapy, biologic agents, radiotherapy, or other nonprotocol antitumor therapy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Central Cancer Treatment Group

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase II Trial of VEGF Trap in Patients With Metastatic Breast Cancer Previously Treated With Anthracycline and/or Taxane

This phase II trial is studying how well VEGF Trap works in treating patients with metastatic breast cancer. VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor

Read the detailed description

PRIMARY OBJECTIVES:

  1. Assess the antitumor activity of VEGF Trap, in terms of tumor response rate, in patients with metastatic breast cancer who have received =< 2 prior chemotherapy regimens for metastatic disease, including a taxane and/or anthracycline.

II. Assess the 6-month progression-free survival rate in patients treated with VEGF Trap.

SECONDARY OBJECTIVES:

  1. Describe the adverse event profile (grade using the NCI CTCAE version 3.0) of VEGF Trap in these patients.

II. Describe the progression-free survival times in patients treated with VEGF Trap.

III. Describe the overall survival of patients treated with VEGF Trap. IV. Describe the duration of response in patients treated with VEGF Trap.

OUTLINE: This is a multicenter study.

Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3-6 months for up to 5 years.

Being tested
ziv-aflibercept
Medical subject headings
Breast Neoplasms

What participants receive

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

  • ziv-afliberceptBiological

    Also called aflibercept, vascular endothelial growth factor trap, VEGF Trap, Zaltrap

Study groups in NCT00369655
Study groupRoleWhat they receive
Treatment (ziv-afibercept)ExperimentalPatients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: ziv-aflibercept

What is being measured

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

  1. Proportion of Patients With Confirmed Tumor Response

    Confirmed tumor response was defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on 2 consecutive evaluations at least 8 weeks apart.

    Measured: Up to 5 years

  2. Proportion of Patients Receiving Vascular Endothelial Growth Factor (VEGF) Trap With 6-month Progression-free Survival

    The 6-month progression free survival rate was defined as the proportion of efficacy-evaluable patients on study treatment and progression-free 6 months from registration. Patients who died without documentation of progression will be considered to have progressed on the date of their death.

    Measured: 6 months

Secondary outcomes (4)

  1. Progression Free Survival

    Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who died without documentation of progression being considered to have progressed on the date of their death.

    Measured: Time from registration to disease progression or death (up to 5 years)

  2. Overall Survival

    Overall survival time was defined as the number of months from registration to the date of death or last follow-up

    Measured: Time from registration to death or last follow up (up to 5 years)

  3. Median Duration of Response

    Duration of response was defined as for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response or partial response to the date progression is documented.

    Measured: Up to 5 years

  4. Number of Participant With Previous Treatment of Anti-HER2 With Cardiac Events

    Measured: Up to 5 years

Timeline

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

  1. First posted29 Aug 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionMar 2008
  4. Study completionJan 2011

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00369655
Sponsor's protocol ID
NCI-2012-01827
Other IDs
NCCTG-N0537, U10CA025224, CDR0000491314
Status last verified
Nov 2013
First submitted
24 Aug 2006
Last updated
5 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ziv-aflibercept in people with Metastatic 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 70 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 5 May 2014. 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?

Yes. Results are posted in the registry (first posted 5 May 2014). 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 With Confirmed Tumor Response (time frame: Up to 5 years). The study lists 2 primary outcomes in all. 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 NCT00369655.

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 5 May 2014.

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