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NCT Number: NCT01777932

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Budapest, Hungary

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jan 29, 2013
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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