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

NCT ID: NCT01661153

Last Updated: 2017-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-02

Study Completion Date

2016-09-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uni Hospital Split; Oncology & Radiotherapy

Split, , Croatia

Site Status

General Hospital Varazdin

Varaždin, , Croatia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Croatia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ML25312

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.