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VEGF Trap in Treating Patients With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00369655
Recruitment Status : Completed
First Posted : August 29, 2006
Results First Posted : May 5, 2014
Last Update Posted : May 5, 2014
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief 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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer Biological: ziv-aflibercept Phase 2

Detailed Description:


I. 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.


I. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of VEGF Trap in Patients With Metastatic Breast Cancer Previously Treated With Anthracycline and/or Taxane
Study Start Date : January 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Treatment (ziv-afibercept)
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.
Biological: ziv-aflibercept
Other Names:
  • aflibercept
  • vascular endothelial growth factor trap
  • VEGF Trap
  • Zaltrap

Primary Outcome Measures :
  1. Proportion of Patients With Confirmed Tumor Response [ Time Frame: Up to 5 years ]
    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.

  2. Proportion of Patients Receiving Vascular Endothelial Growth Factor (VEGF) Trap With 6-month Progression-free Survival [ Time Frame: 6 months ]
    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.

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Time from registration to disease progression or death (up to 5 years) ]
    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.

  2. Overall Survival [ Time Frame: Time from registration to death or last follow up (up to 5 years) ]
    Overall survival time was defined as the number of months from registration to the date of death or last follow-up

  3. Median Duration of Response [ Time Frame: Up to 5 years ]
    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.

  4. Number of Participant With Previous Treatment of Anti-HER2 With Cardiac Events [ Time Frame: Up to 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00369655

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United States, Minnesota
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Edith Perez North Central Cancer Treatment Group
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00369655    
Other Study ID Numbers: NCI-2012-01827
U10CA025224 ( U.S. NIH Grant/Contract )
CDR0000491314 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: August 29, 2006    Key Record Dates
Results First Posted: May 5, 2014
Last Update Posted: May 5, 2014
Last Verified: November 2013
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs