Phase 2
N=90
A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00846027 ↗Enrolled (actual)
90
Serious AEs
25.6%
Results posted
Jun 2014
Primary outcome: Primary: Progression-free Survival — 11.51 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Drug); Paclitaxel (Drug); Gemcitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
11.51 | — |
| SECONDARY Percentage of Participants With an Objective Response |
72.37 | — |
| SECONDARY Duration of the Objective Response |
12.39 | — |
| SECONDARY Overall Survival |
27.39 | — |
Summary
This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel 150 mg/m^2 iv, and gemcitabine 200 mg/m^2 iv on Day 1 and Day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.
Eligibility Criteria
Inclusion Criteria
- Female patients, ≥ 18 years of age.
- Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only.
- HER-2 negative disease.
- Candidates for chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Exclusion Criteria
- Previous chemotherapy for metastatic or locally advanced breast cancer.
- Previous radiotherapy for treatment of metastatic breast cancer.
- Any prior adjuvant treatment with anthracyclines completed 325 mg/day) or clopidogrel (> 75mg/day).
Data sourced from ClinicalTrials.gov (NCT00846027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.