Post Registration Observational Program for Patients With Locally Recurrent or Metastatic Breast Cancer Who Receive Bevacizumab (Avastin) in Combination With Paclitaxel for the First-line Treatment
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer
Both
Breast Cancer
Trial Information
Post Registration Observational Program for Patients With Locally Recurrent or Metastatic Breast Cancer Who Receive Bevacizumab (Avastin) in Combination With Paclitaxel for the First-line Treatment
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Locally recurrent or metastatic Her2-negative breast cancer
- Locally recurrent disease must not be amenable to radiation therapy or resection with
curative intent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Prior Adjuvant chemotherapy allowed; if taxane-based a disease-free interval after
completion of >/=12 months is required
- Adequate haematological, renal and liver function
Exclusion Criteria:
- Previous chemotherapy for locally recurrent or metastatic disease
- Radiation therapy for metastatic disease (except for relief of metastatic bone pain
with irradiation of
- CNS metastases
- Pre-existing peripheral neuropathy
- Clinically significant cardiovascular disease
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety profile: Adverse events
Outcome Time Frame:
approximately 2 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Russia: Ministry of Health of the Russian Federation
Study ID:
ML25081
NCT ID:
NCT01156961
Start Date:
October 2010
Completion Date:
December 2012
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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