Study identifier:D8530C00003
ClinicalTrials.gov identifier:NCT04588298
EudraCT identifier:2020-001079-33
CTIS identifier:N/A
A Randomised, Open-Label, Parallel-Group, Pre-surgical Study to Investigate the Biological Effects of AZD9833 in Women with ER-positive, HER2-negative Primary Breast Cancer (SERENA-3)
HER2-negative breast cancer
Phase 2
No
AZD9833
Female
135
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Stage 1: AZD9833 Dose A Post-menopausal participants will receive once daily oral dose A of AZD9833 in stage 1 of the study. | Drug: AZD9833 AZD9833 tablets will be administered orally. |
Experimental: Stage 1: AZD9833 Dose B Post-menopausal participants will receive once daily oral dose B of AZD9833 in stage 1 of the study. | Drug: AZD9833 AZD9833 tablets will be administered orally. |
Experimental: Stage 2: AZD9833 Dose A Post-menopausal participants will receive once daily oral dose A of AZD9833 in stage 2 of the study. | Drug: AZD9833 AZD9833 tablets will be administered orally. |
Experimental: Stage 2: AZD9833 Dose B Post-menopausal participants will receive once daily oral dose B of AZD9833 in stage 2 of the study. | Drug: AZD9833 AZD9833 tablets will be administered orally. |
Experimental: Stage 2: AZD9833 Dose C Post-menopausal participants will receive once daily oral dose C of AZD9833 in stage 2 of the study. | Drug: AZD9833 AZD9833 tablets will be administered orally. |
Experimental: Stage 3: AZD9833 Dose A Post-menopausal participants will receive once daily oral dose A of AZD9833 in stage 3 of the study. | Drug: AZD9833 AZD9833 tablets will be administered orally. |
Experimental: Stage 3: AZD9833: Dose B Post-menopausal participants will receive once daily oral dose B of AZD9833 in stage 3 of the study. | Drug: AZD9833 AZD9833 tablets will be administered orally. |