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

Study Overview
=================
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.

Official Title
-----------------
Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy Plus Bevacizumab in Women With HER2-Negative Metastatic Breast Cancer. An Observational Study.

Conditions
-----------------
Metastatic Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Avastin regimens<br>Patients who are going to receive chemotherapy plus Avastin (bevacizumab) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | In this observational study investigators are going to assess standard schedules in which administration was every 2 or 3 weeks | Every 2 or 3 weeks up to 12 or 18 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HER2 negative, Chemotherapy, Anti-angiogenic agent, Bevacizumab, 1st Line, mBC