AVAREG Study: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT01777932
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- 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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival Approximately 5 years Progression free survival (PFS) was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment.
- Secondary Outcome Measures
Name Time Method Time to Discontinuation (TTD) of Bevacizumab Treatment Approximately 5 years 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.
Participants With Hormone Receptor Status at Diagnosis Baseline (Day 1) 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.
Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry Approximately 5 years 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.
Participants With Prior Therapy at Study Entry (Baseline) Baseline (Day 1) The status of prior therapy (i.e. chemotherapy, endocrine therapy, and radiotherapy) at study entry (baseline) is reported.
Participants With Proteinuria at Study Entry (Baseline) Baseline (Day 1) The number of participants with proteinurea status as positive, negative or missing is reported.
Participants With Type of Metastases at Study Entry (Baseline) Baseline (Day 1) The type of metastases (bone and visceral) are reported at study entry (baseline) is reported.
One Year Survival Approximately 5 years The status of participants whether alive, dead, unknown or missing one year after the start of bevacizumab treatment is reported.
Participants With Tumor Stage at Diagnosis Baseline (Day 1) Number of participants at each Metastatic breast cancer stage 0, I, II, III or IV, at the point of diagnosis is reported.
Participants With Eastern Cooperative Oncology Group Status at Study Entry Baseline (Day 1) 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.
Participants With Disease History at Study Entry (Baseline) Baseline (Day 1) Participant's history at the time of diagnosis of metastatic disease and sites of metastases is reported at study entry (baseline).