Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Breast Cancer

Hellenic Oncology Research Group

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Bevacizumab

Drug: Vinorelbine

Study type

Interventional

Funder types

Other

Identifiers

NCT00694200

CT/08.03

Details and patient eligibility

About

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.

Full 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, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone.

Enrollment

13 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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