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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01777932
First received: January 24, 2013
Last updated: January 7, 2016
Last verified: January 2016
  Purpose
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.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Single-arm, Observational Study Describing the Clinical Benefits of Bevacizumab (Avastin) Treatment in Patients With Metastatic Breast Cancer (AVAREG Study)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
    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:
  • One Year Survival [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    The number of participants with proteinurea status as positive, negative or missing is reported.


Enrollment: 220
Study Start Date: December 2007
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with metastatic breast cancer initiated on treatment with Avastin in combination with paclitaxel
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777932

Locations
Hungary
Budapest, Hungary, 1145
Budapest, Hungary, 1076
Budapest, Hungary, 1031
Budapest, Hungary, 1088
Budapest, Hungary, 1097
Budapest, Hungary, 1106
Budapest, Hungary, 1115
Budapest, Hungary, 1122
Budapest, Hungary, 1125
Budapest, Hungary, 1135
Budapest, Hungary, 1082
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01777932     History of Changes
Other Study ID Numbers: ML21647 
Study First Received: January 24, 2013
Results First Received: January 7, 2016
Last Updated: January 7, 2016
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2016