A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
AZD9833: Dosage formulation: AZD9833 tablets will be administered orally.
Fulvestrant: Dosage formulation: Fulvestrant will be administered via intramuscular (IM) injection.
Study summary
This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.
Eligibility
Primary outcome measure(s)
- Progression-free Survival (PFS) — From date of randomisation to date of objective disease progression (or last evaluable assessment in the absence of progression) or death (up to data cut-off of 29 months)
PFS was assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1. PFS was defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or received another anti-cancer therapy prior to progression. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. Data from the 300mg arm should be interpreted with caution as recruitment to the 300mg arm was stopped early at 20 patients randomised and therefore the 300mg data is highly variable.
Trial sites (85)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Birmingham | Alabama | |
| Research Site | Long Beach | California | |
| Research Site | Fort Myers | Florida | |
| Research Site | St. Petersburg | Florida | |
| Research Site | Lincoln | Nebraska | |
| Research Site | Canton | Ohio | |
| Research Site | Chattanooga | Tennessee | |
| Research Site | Nashville | Tennessee | |
| Research Site | Eagle River | Wisconsin | |
| Research Site | Brasschaat | Belgium | |
| Research Site | Charleroi | Belgium | |
| Research Site | Ghent | Belgium | |
| Research Site | Haine-Saint-Paul | Belgium | |
| Research Site | Leuven | Belgium | |
| Research Site | Libramont-Chevigny | Belgium | |
| Research Site | Namur | Belgium | |
| Research Site | Greenfield Park | Quebec | |
| Research Site | Montreal | Quebec | |
| Research Site | Montreal | Quebec | |
| Research Site | Paris | France | |
| Research Site | Vandœuvre-lès-Nancy | France | |
| Research Site | Batumi | Georgia | |
| Research Site | Tbilisi | Georgia | |
| Research Site | Tbilisi | Georgia | |
| Research Site | Tbilisi | Georgia | |
| Research Site | Tbilisi | Georgia | |
| Research Site | Tbilisi | Georgia | |
| Research Site | Berlin | Germany | |
| Research Site | Düsseldorf | Germany | |
| Research Site | Essen | Germany | |
| Research Site | Budapest | Hungary | |
| Research Site | Debrecen | Hungary | |
| Research Site | Kaposvár | Hungary | |
| Research Site | Kecskemét | Hungary | |
| Research Site | Nyíregyháza | Hungary | |
| Research Site | Pécs | Hungary | |
| Research Site | Szeged | Hungary | |
| Research Site | Jerusalem | Israel | |
| Research Site | Jerusalem | Israel | |
| Research Site | Nahariya | Israel |
+ 45 more sites — see the full list on the official registry below.
More AstraZeneca trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04214288 on ClinicalTrials.gov ↗ ← All trials in South Korea