Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy In Metastatic Breast Cancer

Completed

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT01978977
• Lead Sponsor: Hellenic Oncology Research Group

Brief Summary

Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as first line treatment of patients with metastatic Breast Cancer.

Detailed Description

Nowadays in clinical practice patients with previously untreated metastatic breast cancer often receive taxane-based chemotherapy (paclitaxel or docetaxel) in combination with bevacizumab as it has been shown to increase progression-free survival. There is currently minimal information whether bevacizumab should be given as maintenance therapy after discontinuation of chemotherapy.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2013-11-03
• Study First Submitted QC: 2013-11-03
• Study First Posted: 2013-11-08
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Written informed consent
• Age ≥18 years
• Patients with histologically or cytologically confirmed, HER2-negative, metastatic Breast Cancer
• No prior first line treatment for metastatic Breast Cancer
• Previous hormonotherapy for metastatic Breast Cancer is allowed
• One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria
• ECOG performance status ≤2
• Adequate haematological, renal and hepatic function
• Urine protein <2+ (dipstick)
• Life expectancy of ≥12 weeks

Exclusion Criteria

• Previous first line treatment for metastatic colorectal cancer(progression >12 months after the end of adjuvant treatment)
• Previous radiotherapy to target lesions
• Patients with brain metastases and/or cancerous meningitis
• Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
• Patients participating in interventional clinical trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	Every 2 or 3 weeks up to 12 or 18 weeks	In this observational study investigators are going to assess standard schedules in which administration was every 2 or 3 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Response Rate	Disease evaluation at Week 3 or at week 6	In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 3 or 6 weeks
Percentage of Patients with Progression Free Survival	1 year
Patients Overall Survival	1 year

Trial Locations

Locations (6)

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

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology; 🇬🇷 Piraeus, Greece

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

"IASO" General Hospital of Athens; 🇬🇷 Athens, Greece

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

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