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 - SERENA-2

Study identifier:D8530C00002

ClinicalTrials.gov identifier:NCT04214288

EudraCT identifier:2019-003706-27

CTIS identifier:2023-504974-40-00

Recruitment Complete

Official Title

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

Medical condition

Advanced ER-Positive HER2-Negative Breast Cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

AZD9833, Fulvestrant

Sex

Female

Actual Enrollment

240

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 22 Apr 2020
Primary Completion Date: 30 Aug 2022
Estimated Study Completion Date: 28 Mar 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria