Phase 2
Completed N=62
AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.
Source: ClinicalTrials.gov NCT00454805 ↗Enrolled (actual)
62
Serious AEs
30.7%
Results posted
Nov 2012
Primary outcomePrimary: Progression Free Survival — 223; 112 Days
Summary
The purpose of this study is to determine whether AZD2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
223; 112 | — |
| SECONDARY Objective Response Rate |
4; 1 | — |
| SECONDARY Duration of Response |
207.5; 224.0 | — |
| SECONDARY Clinical Benefit Rate |
0.419; 0.419 | — |
| SECONDARY Duration of Clinical Benefit |
306.6; 343.8 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- Females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease
- One or more evaluable lesions
Exclusion Criteria
- Prior hormonal therapy with fulvestrant
- More than one course of prior systemic cytotoxic chemotherapy for metastatic breast cancer
- Prior biologic therapy for ABC including Anti-VEGF agents
- Radiation therapy within 4 weeks prior to provision of consent
Data sourced from ClinicalTrials.gov (NCT00454805). 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.