A comparative study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease - SERENA-4

Study identifier:D8532C00001

ClinicalTrials.gov identifier:NCT04711252

EudraCT identifier:2020-002276-12

CTIS identifier:2023-503995-26-00

Recruiting

Official Title

SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) plus Palbociclib versus Anastrozole plus Palbociclib for the Treatment of Patients with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

Medical condition

ER-Positive HER2-Negative Breast Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

AZD9833, Anastrozole, Anastrozole placebo, AZD9833 placebo, Palbociclib, Luteinizing hormone-releasing hormone (LHRH) agonist

Sex

All

Estimated Enrollment

1342

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 28 Jan 2021
Estimated Primary Completion Date: 24 Aug 2026
Estimated Study Completion Date: 01 Feb 2029

Study design

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

Verification:

Verified 01 Nov 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria