Phase 3
Completed N=2,296
A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.
Source: ClinicalTrials.gov NCT00448591 ↗Enrolled (actual)
2,296
Serious AEs
29.7%
Results posted
May 2015
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs) — 95.4; 57.6; 64.2; 29.7 percentage of participants
Summary
This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs) |
95.4; 57.6; 64.2; 29.7; 7.6; 53.1 | — |
| SECONDARY Percentage of Participants With Disease Progression |
72.44 | — |
| SECONDARY Time to Progression (TTP) |
9.7 | — |
| SECONDARY Percentage of Participants With Recorded Death |
53.14 | — |
| SECONDARY Overall Survival |
25.2 | — |
| SECONDARY Percentage of Participants by Best Overall Response to Treatment |
9.0; 45.1; 32.4; 9.1; 0.1; 4.2 | — |
Eligibility Criteria
Inclusion Criteria
- patients, >=18 years of age;
- HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting;
- candidates for chemotherapy.
Exclusion Criteria
- previous chemotherapy for metastatic or locally recurrent breast cancer;
- concomitant hormonal therapy for metastatic or locally recurrent disease;
- concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease;
- previous radiotherapy for treatment of metastatic disease;
- evidence of CNS metastases.
Data sourced from ClinicalTrials.gov (NCT00448591). 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. Informational only — not medical advice.