NCT00694200

Brief Summary

To evaluate the efficacy of metronomic oral vinorelbine taken three times a week without break plus bevacizumab as salvage treatment in patients with metastatic breast cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

9 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

June 6, 2008

Last Update Submit

May 27, 2015

Conditions

Breast Cancer

Keywords

breast cancerchemotherapyanti-angiogenesis therapy

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcomes (3)

  • Duration of response

    1 year

  • Progression free survival

    1 year

  • Overall survival

    1 year

Study Arms (1)

1

EXPERIMENTAL

Vinorelbine metronomic + bevacizumab

Drug: VinorelbineDrug: Bevacizumab

Interventions

VinorelbineDRUG

Vinorelbine per os 50 mg 3 times a week

Also known as: Navelbine
1
BevacizumabDRUG

Bevacizumab 10 mg/kg IV every 14 days

Also known as: Avastin
1

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
  • At least one previous chemotherapy regimen for metastatic breast cancer
  • Age 18-75 years
  • Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
  • Performance status (WHO) 0-2
  • Adequate liver function(serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases), adequate renal function (serum creatinine \<1.5 times the upper normal limit) and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
  • No radiation of measurable disease (except brain metastases)
  • No progressive brain metastases according to clinical or radiological criteria
  • No brain metastases without prior radiation therapy
  • Written informed consent

You may not qualify if:

  • Patient unable to take oral medication
  • Active infection
  • History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  • History of stroke
  • Anticoagulation therapy (except of low dose aspirin \<325mg)
  • Other invasive malignancy except nonmelanoma skin cancer
  • Psychiatric illness or social situation that would preclude study compliance
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Greece

Location

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

VinorelbineBevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Dimitris Mavrudis, MD

    University Hospital of Crete, Dep of Medical Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2008

First Posted

June 10, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

GR(9)