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NCT Number: NCT01978977

Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy In Metastatic Breast Cancer

Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as first line treatment of patients with metastatic Breast Cancer.

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Key information

Conditions

Metastatic 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

University Hospital of Crete, Dep of Medical Oncology, Heraklion, Crete, Greece

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About this study

Nowadays in clinical practice patients with previously untreated metastatic breast cancer often receive taxane-based chemotherapy (paclitaxel or docetaxel) in combination with bevacizumab as it has been shown to increase progression-free survival. There is currently minimal information whether bevacizumab should be given as maintenance therapy after discontinuation of chemotherapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent
  • Age ≥18 years
  • Patients with histologically or cytologically confirmed, HER2-negative, metastatic Breast Cancer
  • No prior first line treatment for metastatic Breast Cancer
  • Previous hormonotherapy for metastatic Breast Cancer is allowed
  • One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria
  • ECOG performance status ≤2
  • Adequate haematological, renal and hepatic function
  • Urine protein <2+ (dipstick)
  • Life expectancy of ≥12 weeks

Exclusion criteria

  • Previous first line treatment for metastatic colorectal cancer(progression >12 months after the end of adjuvant treatment)
  • Previous radiotherapy to target lesions
  • Patients with brain metastases and/or cancerous meningitis
  • Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
  • Patients participating in interventional clinical trial

Treatment and study plan

Primary outcomes

  1. Number of Participants with Adverse Events

    Time frame: Every 2 or 3 weeks up to 12 or 18 weeks

    In this observational study investigators are going to assess standard schedules in which administration was every 2 or 3 weeks

Secondary outcomes

  1. Number of Participants with Response Rate

    Time frame: Disease evaluation at Week 3 or at week 6

    In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 3 or 6 weeks

  2. Percentage of Patients with Progression Free Survival

    Time frame: 1 year

  3. Patients Overall Survival

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Hellenic Oncology Research Group

Other

Registry information

Official study title

Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy Plus Bevacizumab in Women With HER2-Negative Metastatic Breast Cancer. An Observational Study.

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 8, 2013
Registry last updated
Oct 7, 2015

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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