Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Breast Cancer

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Vinorelbine; Drug: Bevacizumab

• Registration Number: NCT00694200
• Lead Sponsor: Hellenic Oncology Research Group

Brief Summary

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.

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

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-06
• Study First Submitted QC: 2008-06-09
• Study First Posted: 2008-06-10
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Bevacizumab	Vinorelbine metronomic + bevacizumab
1	Vinorelbine	Vinorelbine metronomic + bevacizumab

Primary Outcome Measures

Name	Time	Method
Response rate	Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcome Measures

Name	Time	Method
Progression free survival	1 year
Duration of response	1 year
Overall survival	1 year

Trial Locations

Locations (9)

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology; 🇬🇷 Athens, Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine; 🇬🇷 Athens, Greece

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology; 🇬🇷 Athens, Greece

401 Military Hospital of Athens; 🇬🇷 Athens, Greece

Air Forces Military Hospital of Athens; 🇬🇷 Athens, Greece

University Hospital of Crete, Dep of Medical Oncology; 🇬🇷 Heraklion, Greece

State General Hospital of Larissa, Dep of Medical Oncology; 🇬🇷 Larissa,, Greece

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology; 🇬🇷 Thessaloniki, Greece