Study identifier:D8530C00002
ClinicalTrials.gov identifier:NCT04214288
EudraCT identifier:2019-003706-27
CTIS identifier:2023-504974-40-00
SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 versus Fulvestrant in Women with Advanced ER-Positive HER2-Negative Breast Cancer
Advanced ER-Positive HER2-Negative Breast Cancer
Phase 2
No
AZD9833, Fulvestrant
Female
240
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: AZD9833 Dose A The patients will receive AZD9833 (Dose A). | Drug: AZD9833 Dosage formulation: AZD9833 tablets will be administered orally. |
Experimental: AZD9833 Dose B The patients will receive AZD9833 (Dose B). | Drug: AZD9833 Dosage formulation: AZD9833 tablets will be administered orally. |
Experimental: AZD9833 Dose C The patients will receive AZD9833 (Dose C). | Drug: AZD9833 Dosage formulation: AZD9833 tablets will be administered orally. |
Active Comparator: Fulvestrant 500 mg The patients will receive Fulvestrant (500 mg). | Drug: Fulvestrant Dosage formulation: Fulvestrant will be administered via intramuscular (IM) injection. |