AVAREG Study: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01777932|
Recruitment Status : Completed
First Posted : January 29, 2013
Results First Posted : February 5, 2016
Last Update Posted : February 5, 2016
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||220 participants|
|Official Title:||A Multicenter, Single-arm, Observational Study Describing the Clinical Benefits of Bevacizumab (Avastin) Treatment in Patients With Metastatic Breast Cancer (AVAREG Study)|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
- Progression Free Survival [ Time Frame: 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.
- One Year Survival [ Time Frame: Approximately 5 years ]The status of participants whether alive, dead, unknown or missing one year after the start of bevacizumab treatment is reported.
- Time to Discontinuation (TTD) of Bevacizumab Treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Tumor Stage at Diagnosis [ Time Frame: 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 [ Time Frame: 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 Prior Therapy at Study Entry (Baseline) [ Time Frame: Baseline (Day 1) ]The status of prior therapy (i.e. chemotherapy, endocrine therapy, and radiotherapy) at study entry (baseline) is reported.
- Participants With Disease History at Study Entry (Baseline) [ Time Frame: Baseline (Day 1) ]Participant's history at the time of diagnosis of metastatic disease and sites of metastases is reported at study entry (baseline).
- Participants With Type of Metastases at Study Entry (Baseline) [ Time Frame: Baseline (Day 1) ]The type of metastases (bone and visceral) are reported at study entry (baseline) is reported.
- Participants With Proteinuria at Study Entry (Baseline) [ Time Frame: Baseline (Day 1) ]The number of participants with proteinurea status as positive, negative or missing is reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777932
|Budapest, Hungary, 1031|
|Budapest, Hungary, 1076|
|Budapest, Hungary, 1082|
|Budapest, Hungary, 1088|
|Budapest, Hungary, 1097|
|Budapest, Hungary, 1106|
|Budapest, Hungary, 1115|
|Budapest, Hungary, 1122|
|Budapest, Hungary, 1125|
|Budapest, Hungary, 1135|
|Budapest, Hungary, 1145|
|Debrecen, Hungary, 4012|
|Debrecen, Hungary, H-4031|
|Eger, Hungary, 3300|
|Gyor, Hungary, 9023|
|Gyula, Hungary, 5700|
|Kaposvar, Hungary, 7400|
|Kecskemet, Hungary, 6000|
|Kistarcsa, Hungary, 2143|
|Miskolc, Hungary, 3526|
|Nyíregyháza, Hungary, 4400|
|Pecs, Hungary, 7624|
|Salgótarján, Hungary, 3100|
|Szeged, Hungary, 6720|
|Szekesfehervar, Hungary, 8000|
|Szekszard, Hungary, 7100|
|Szentes, Hungary, 6600|
|Szolnok, Hungary, 5004|
|Szombathely, Hungary, 9700|
|Tatabánya, Hungary, 2800|
|Veszprem, Hungary, 8200|
|Zalaegerszeg, Hungary, 8900|
|Study Director:||Clinical Trials||Hoffmann-La Roche|