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

Hellenic Oncology Research Group

Status: Completed

Conditions: Metastatic Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01978977

CT/10.17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

Avastin regimens

Description:

Patients who are going to receive chemotherapy plus Avastin (bevacizumab)