N/A
N=220
AVAREG Study: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01777932 ↗Enrolled (actual)
220
Serious AEs
8.6%
Results posted
Feb 2016
Primary outcome: Primary: Progression Free Survival — 9.3 months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
9.3 | — |
| SECONDARY One Year Survival |
150; 37; 13; 20 | — |
| SECONDARY Time to Discontinuation (TTD) of Bevacizumab Treatment |
7.0 | — |
| SECONDARY Participants With Hormone Receptor Status at Diagnosis |
98; 117; 3; 2; 90; 125 | — |
| SECONDARY Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry |
8.30; 13.30 | — |
| SECONDARY Participants With Tumor Stage at Diagnosis |
1; 38; 87; 39; 50; 5 | — |
| SECONDARY Participants With Eastern Cooperative Oncology Group Status at Study Entry |
164; 45; 7; 4 | — |
| SECONDARY Participants With Prior Therapy at Study Entry (Baseline) |
64; 152; 1; 3; 135; 80 | — |
| SECONDARY Participants With Disease History at Study Entry (Baseline) |
44; 91; 79; 6; 101; 96 | — |
| SECONDARY Participants With Type of Metastases at Study Entry (Baseline) |
16; 196; 8; 113; 100; 7 | — |
| SECONDARY Participants With Proteinuria at Study Entry (Baseline) |
3; 215; 2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01777932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.