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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661153
• Other study ID #: ML25312
• Status: Completed
• Phase: N/A
• First received: August 7, 2012
• Last updated: August 24, 2017
• Start date: March 2, 2011
• Est. completion date: September 14, 2016

Study information

• Verified date: August 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 14, 2016
• Est. primary completion date: September 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Croatia	Uni Hospital Split; Oncology & Radiotherapy	Split
Croatia	General Hospital Varazdin	Varazdin

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		approximately 2.5 years
Secondary	Dosage/schedule/number of cycles of Avastin treatment in clinical practice		approximately 2.5 years
Secondary	Safety: Incidence of adverse events		approximately 2.5 years