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

August 24, 2017 updated by: Hoffmann-La Roche

A Non-interventional Study of Avastin in Combination With Paclitaxel for First Line Treatment in 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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Study Type

Observational

Enrollment (Actual)

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

Croatia
- - Split, Croatia, 21000
    - Uni Hospital Split; Oncology & Radiotherapy
  - Varazdin, Croatia, 42000
    - General Hospital Varazdin

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HER2-negative breast cancer patients in first-line treatment of metastatic disease

Description

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

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

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival Time Frame: approximately 2.5 years	approximately 2.5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events Time Frame: approximately 2.5 years	approximately 2.5 years
Dosage/schedule/number of cycles of Avastin treatment in clinical practice Time Frame: approximately 2.5 years	approximately 2.5 years

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 (ACTUAL)

March 2, 2011

Primary Completion (ACTUAL)

September 14, 2016

Study Completion (ACTUAL)

September 14, 2016

Study Registration Dates

First Submitted

August 7, 2012

First Submitted That Met QC Criteria