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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01661153

Enrollment

Registered

2012-08-09

Start date

2011-03-02

Completion date

2016-09-14

Last updated

2017-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival	approximately 2.5 years

Secondary

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

Countries

Croatia

Outcome results