Open-label Study of Bevacizumab (Avastin) and Taxane Monotherapy for the First-line Treatment of Patients With Advanced Triple Negative Breast Cancer.
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
Open-label Study of Bevacizumab (Avastin) and Taxane Monotherapy for the First-line Treatment of Patients With Advanced Triple Negative Breast Cancer.
Inclusion Criteria:
- Adult patients >/=18 years of age
- Histologically confirmed triple-negative (oestrogen and progesterone receptor
(ER/PgR) and HER2 receptor negative) adenocarcinoma of the breast with metastatic
disease
- Patient who in the Investigator's opinion requires combination therapy for their
disease
- Life expectancy >/=12 weeks
Exclusion Criteria:
- Previous chemotherapy for metastatic breast cancer (adjuvant chemotherapy is allowed)
- Patients currently undergoing radiation therapy for the treatment of metastatic
disease (apart from the relief of metastatic bone pain)
- Major surgery or significant traumatic injury within 28 days prior to enrollment or
anticipation of the need for major surgery during study treatment
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety, Tolerability: AEs, quality of life questionnaires
Outcome Time Frame:
AEs: Throughout study until 6 months after final dose of bevacizumab; quality of life questionnaires: every 6 weeks
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
ML22780
NCT ID:
NCT01094184
Start Date:
March 2010
Completion Date:
December 2014
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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