NCT00369655

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

May 5, 2014

Completed
Last Updated

May 5, 2014

Status Verified

November 1, 2013

Enrollment Period

1.2 years

First QC Date

August 24, 2006

Results QC Date

November 25, 2013

Last Update Submit

April 2, 2014

Conditions

Metastatic Breast CancerRecurrent Breast CancerStage IV Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • 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.

    Up to 5 years

  • 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.

    6 months

Secondary Outcomes (4)

  • Progression Free Survival

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

  • Overall Survival

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

  • Median Duration of Response

    Up to 5 years

  • Number of Participant With Previous Treatment of Anti-HER2 With Cardiac Events

    Up to 5 years

Study Arms (1)

Treatment (ziv-afibercept)

EXPERIMENTAL

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

Interventions

ziv-afliberceptBIOLOGICAL
Also known as: aflibercept, vascular endothelial growth factor trap, VEGF Trap, Zaltrap
Treatment (ziv-afibercept)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +55 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. Timothy Hobday
Organization
Mayo Clinic
hobday.timothy@mayo.edu
507-284-1159

Study Officials

  • Edith Perez

    North Central Cancer Treatment Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2006

First Posted

August 29, 2006

Study Start

January 1, 2007

Primary Completion

March 1, 2008

Study Completion

January 1, 2011

Last Updated

May 5, 2014

Results First Posted

May 5, 2014

Record last verified: 2013-11

Locations

US(1)