Know Cancer

forgot password

Vinorelbine Metronomic Plus Lapatinib as Salvage Therapy for Patients With Overexpressing HER-2 Metastatic Breast Cancer. A Multicenter Phase II Study

Phase 2
18 Years
75 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Vinorelbine Metronomic Plus Lapatinib as Salvage Therapy for Patients With Overexpressing HER-2 Metastatic Breast Cancer. A Multicenter Phase II Study

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

3 - 6 month

Safety Issue:


Principal Investigator

Dimitris Mavrudis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete, Dep of Medical Oncology


Greece: National Organization of Medicines

Study ID:




Start Date:

October 2008

Completion Date:

March 2011

Related Keywords:

  • Breast Cancer
  • Vinorelbine metronomic-lapatinib
  • Chemotherapy
  • Targeted therapy
  • Breast Neoplasms