NCT00754702

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of metronomic oral vinorelbine taken three times a week plus daily lapatinib without break, 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
16

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

2 active sites

Status
terminated

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

September 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

2.4 years

First QC Date

September 17, 2008

Last Update Submit

September 25, 2015

Conditions

Breast Cancer

Keywords

Vinorelbine metronomic-lapatinibChemotherapyTargeted therapy

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    3 - 6 month

Secondary Outcomes (4)

  • Progression Free Survival

    1 year

  • Toxicity profile

    21 days

  • Overall Survival

    1 year

  • Quality of life assessment

    42 days

Study Arms (1)

1

EXPERIMENTAL

Vinorelbine metronomic/Lapatinib

Drug: VinorelbineDrug: Lapatinib

Interventions

VinorelbineDRUG

Vinorelbine p.o (50 mg 3 times a week) until disease progression or appearance of unacceptable toxicity

Also known as: Navelbine
1
LapatinibDRUG

Lapatinib p.o every day without interruption disease progression or appearance of unacceptable toxicity

Also known as: Tyverb, Tykerb
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
  • Age 18-75 years
  • HER2 status positive according to the local institution reported grade 3+ staining intensity (on a scale of 0 to 3) by means of immunohistochemical analysis or grade 2+ staining intensity by means of immunohistochemical analysis with gene amplification on fluorescence in situ hybridization
  • Previous therapies had to include, regimens containing an anthracycline and a taxane
  • Previous treatment with trastuzumab, alone or in combination with chemotherapy for locally advanced or metastatic disease, is required
  • 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 (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)
  • 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 (2)

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Crete, Greece

Location

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

Athens, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

VinorelbineLapatinib

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-RingIndolizidinesIndolizinesQuinazolines

Study Officials

  • Dimitris Mavrudis, MD

    University Hospital of Crete, Dep of Medical Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 18, 2008

Study Start

October 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

September 28, 2015

Record last verified: 2015-09

Locations

GR(2)