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

January 7, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1115
      • Budapest, Hungary, 1125
      • Budapest, Hungary, 1122
      • Budapest, Hungary, 1135
      • Budapest, Hungary, 1145
      • Budapest, Hungary, 1088
      • Budapest, Hungary, 1082
      • Budapest, Hungary, 1106
      • Budapest, Hungary, 1097
      • Budapest, Hungary, 1076
      • Budapest, Hungary, 1031
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with metastatic breast cancer initiated on treatment with Avastin in combination with paclitaxel

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 5 years
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.
Approximately 5 years
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.
Baseline (Day 1)
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.
Approximately 5 years
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.
Baseline (Day 1)
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.
Baseline (Day 1)
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.
Baseline (Day 1)
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).
Baseline (Day 1)
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.
Baseline (Day 1)
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.
Baseline (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

January 24, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21647

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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