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Vinorelbine Metronomic Plus Lapatinib for Overexpressing HER-2 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: NCT00754702
Recruitment Status : Terminated (Poor accrual)
First Posted : September 18, 2008
Last Update Posted : September 28, 2015
Information provided by (Responsible Party):
Vassilis Georgoulias, MD, University Hospital of Crete

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Vinorelbine Drug: Lapatinib Phase 2

Detailed Description:
Continuous administration of oral vinorelbine, given three times a week (metronomic) is feasible and exceptionally well tolerated at doses up to 50 mg. Early results show activity against refractory tumors and provide evidence towards clinical proof of efficacy for metronomic chemotherapy. Recently, lapatinib plus capecitabine was proven superior to capecitabine alone in women with HER2-positive advanced breast cancer that has progressed after treatment with regimens that included an anthracycline, a taxane, and trastuzumab.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vinorelbine Metronomic Plus Lapatinib as Salvage Therapy for Patients With Overexpressing HER-2 Metastatic Breast Cancer. A Multicenter Phase II Study
Study Start Date : October 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 1
Vinorelbine metronomic/Lapatinib
Drug: Vinorelbine
Vinorelbine p.o (50 mg 3 times a week) until disease progression or appearance of unacceptable toxicity
Other Name: Navelbine

Drug: Lapatinib
Lapatinib p.o every day without interruption disease progression or appearance of unacceptable toxicity
Other Names:
  • Tyverb
  • Tykerb

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 3 - 6 month ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 1 year ]
  2. Toxicity profile [ Time Frame: 21 days ]
  3. Overall Survival [ Time Frame: 1 year ]
  4. Quality of life assessment [ Time Frame: 42 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT00754702

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University Hospital of Crete, Dep of Medical Oncology
Heraklion, Crete, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
Sponsors and Collaborators
University Hospital of Crete
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Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete, Dep of Medical Oncology
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Responsible Party: Vassilis Georgoulias, MD, MD, University Hospital of Crete Identifier: NCT00754702    
Other Study ID Numbers: CT/08.27
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015
Keywords provided by Vassilis Georgoulias, MD, University Hospital of Crete:
Vinorelbine metronomic-lapatinib
Targeted therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors