Skip to main content
OpenTrials
Completed

NCT Number: NCT01661153

An Observational Study of Avastin (Bevacizumab) in Combination With Paclitaxel in First-Line Treatment in Patients With HER2-Negative Metastatic Breast Cancer

This prospective observational study will evaluate the use in clinical practice, efficacy and safety of Avastin (bevacizumab) in combination with paclitaxel in first line in patients with HER2-negative metastatic breast cancer. Data will be collected from eligible patients for up to 2.5 years.

Completed

Looking for future studies?

Notify Me

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

Uni Hospital Split; Oncology & Radiotherapy, Split, Croatia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, >/= 18 years of age
  • Locally recurrent or metastatic breast cancer
  • No prior treatment for metastatic or locally recurrent disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion criteria

  • History or clinical evidence of brain metastases
  • Pregnancy
  • Uncontrolled hypertension ( systolic > 150 mmHg and/or diastolic > 100 mmHg) or clinically significant (i.e. active) cardiovascular disease
  • Major surgical procedure or significant traumatic injury within 28 days prior to enrolment

Treatment and study plan

Primary outcomes

  1. Progression-free survival

    Time frame: approximately 2.5 years

Secondary outcomes

  1. Dosage/schedule/number of cycles of Avastin treatment in clinical practice

    Time frame: approximately 2.5 years

  2. Safety: Incidence of adverse events

    Time frame: approximately 2.5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Non-interventional Study of Avastin in Combination With Paclitaxel for First Line Treatment in HER2 Negative Metastatic Breast Cancer

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 9, 2012
Registry last updated
Aug 25, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.