Metastatic Breast Cancer
Conditions
Keywords
mBC, HER2 negative, Chemotherapy, Anti-angiogenic agent, Bevacizumab, 1st Line
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.
Interventions
None listed
Sponsors
Hellenic Oncology Research Group
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Greece
Outcome results
None listed