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

Roche

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01661153

ML25312

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

16 participants in 1 patient group

Cohort