An Observational Study of Avastin (Bevacizumab) in Combination With Paclitaxel in First-Line Treatment in Patients With HER2-Negative Metastatic Breast Cancer
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT01661153
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival approximately 2.5 years
- Secondary Outcome Measures
Name Time Method Dosage/schedule/number of cycles of Avastin treatment in clinical practice approximately 2.5 years Safety: Incidence of adverse events approximately 2.5 years
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie bevacizumab-paclitaxel synergy in HER2-negative metastatic breast cancer?
How does bevacizumab combination therapy compare to standard-of-care regimens in HER2-negative metastatic breast cancer patients?
Which biomarkers correlate with response to bevacizumab-paclitaxel combination therapy in HER2-negative metastatic breast cancer?
What are the most common adverse events associated with bevacizumab-paclitaxel combination therapy in metastatic breast cancer patients?
Are there alternative anti-angiogenic agents or combination strategies to bevacizumab-paclitaxel for HER2-negative metastatic breast cancer?
Trial Locations
- Locations (2)
Uni Hospital Split; Oncology & Radiotherapy
🇭🇷Split, Croatia
General Hospital Varazdin
🇭🇷Varazdin, Croatia
Uni Hospital Split; Oncology & Radiotherapy🇭🇷Split, Croatia