Clinical trial · Interventional
AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.
A Phase II, Double-Blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of AZD2171 in Combination With Fulvestrant vs Fulvestrant Alone in Hormone Sensitive (ER+ve or PgR+ve) Post Menopausal Metastatic Breast Cancer Patients
NCT00454805CI-TRIAL-00023343completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD2171 | Drug | Cediranib | ALIAS |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Fulvestrant Monotherapy
- interventionNames
- Drug: Fulvestrant
- type
- EXPERIMENTAL
- label
- 3
- description
- AZD2171 + Fulvestrant
- interventionNames
- Drug: AZD2171
- Drug: Fulvestrant
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHyams DM, Chan A, de Oliveira C, Snyder R, Vinholes J, Audeh MW, Alencar VM, Lombard J, Mookerjee B, Xu J, Brown K, Klein P. Cediranib in combination with fulvestrant in hormone-sensitive metastatic breast cancer: a randomized Phase II study. Invest New Drugs. 2013 Oct;31(5):1345-54. doi: 10.1007/s10637-013-9991-2. Epub 2013 Jun 26. PMID 23801303