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Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Patients With 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 Bevacizumab as Salvage Therapy for Patients With 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, initial therapy of metastatic breast cancer with
paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared
with paclitaxel alone.

Inclusion Criteria:

- 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

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)

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

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

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:

April 2008

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • breast cancer
  • chemotherapy
  • anti-angiogenesis therapy
  • Breast Neoplasms