AVAREG Study: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer

Study Overview
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Brief Summary
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This multicenter, single-arm observational study will evaluate the clinical benefits of Avastin (bevacizumab) in combination with paclitaxel in first-line treatment in patients with metastatic breast cancer. Patients with metastatic breast cancer who have started Avastin treatment within 6 months prior to study start will also be eligible. Data will be collected from patients for up to 5 years.

Official Title
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A Multicenter, Single-arm, Observational Study Describing the Clinical Benefits of Bevacizumab (Avastin) Treatment in Patients With Metastatic Breast Cancer (AVAREG Study)

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with metastatic breast cancer initiated on first-line treatment with Avastin in combination with paclitaxel according to the current Hungarian summary of Product Characteristics Patients with metastatic breast cancer initiated within 6 months before the start of the study on treatment with Avastin according to the current Hungarian Summary of Product Characteristics Exclusion Criteria: Contraindications for Avastin according to the current Hungarian Summary of Product Characteristics: Hypersensitivity to active ingredient of Avastin or to any excipients Hypersensitivity to products produced in Chinese hamster cells or to other recombinant or humanized antibodies Pregnancy Untreated central nervous system metastases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Progression free survival (PFS) was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment. | Approximately 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One Year Survival | The status of participants whether alive, dead, unknown or missing one year after the start of bevacizumab treatment is reported. | Approximately 5 years | 
| Time to Discontinuation (TTD) of Bevacizumab Treatment | Time to treatment discontinuation is defined as the time to change of therapy due to any cause (tumour progression, toxicity, or other causes) from the start of bevacizumab treatment. | Approximately 5 years | 
| Participants With Hormone Receptor Status at Diagnosis | The hormone receptor status for Oestrogen (ER), Progesterone (PgR) and Human epidermal growth factor receptor (HER-2) is reported as positive, negative, unknown or missing. | Baseline (Day 1) | 
| Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry | PFS was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment for participants with triple negative status and not triple negative status. | Approximately 5 years | 
| Participants With Tumor Stage at Diagnosis | Number of participants at each Metastatic breast cancer stage 0, I, II, III or IV, at the point of diagnosis is reported. | Baseline (Day 1) | 
| Participants With Eastern Cooperative Oncology Group Status at Study Entry | The Eastern Cooperative Oncology Group (ECOG) status for participants was categorized as 0, 1, 2, or missing. ECOG has 4 grades as: 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care, totally confined to bed/chair. | Baseline (Day 1) | 
| Participants With Prior Therapy at Study Entry (Baseline) | The status of prior therapy (i.e. chemotherapy, endocrine therapy, and radiotherapy) at study entry (baseline) is reported. | Baseline (Day 1) | 
| Participants With Disease History at Study Entry (Baseline) | Participant's history at the time of diagnosis of metastatic disease and sites of metastases is reported at study entry (baseline). | Baseline (Day 1) | 
| Participants With Type of Metastases at Study Entry (Baseline) | The type of metastases (bone and visceral) are reported at study entry (baseline) is reported. | Baseline (Day 1) | 
| Participants With Proteinuria at Study Entry (Baseline) | The number of participants with proteinurea status as positive, negative or missing is reported. | Baseline (Day 1) |