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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777932
• Other study ID #: ML21647
• Status: Completed
• Phase: N/A
• First received: January 24, 2013
• Last updated: January 7, 2016
• Start date: December 2007
• Est. completion date: March 2012

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Participants With Proteinuria at Study Entry (Baseline)	The number of participants with proteinurea status as positive, negative or missing is reported.	Baseline (Day 1)	No