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.

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

Summary:

The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer.

Trial Description

Primary Outcome:

• Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumours (RECIST) version 1.1

Secondary Outcome:

• Overall survival (OS)
• Second progression-free survival (PFS2)
• Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1
• Duration of response (DoR) assessed by the Investigator as defined by RECIST version 1.1
• Time to chemotherapy (TTC)
• Time to first subsequent anti-cancer therapy (TFST)
• Clinical benefit rate at 24 weeks (CBR24)
• Time to second subsequent therapy (TSST)
• Plasma concentration of AZD9833 at specified timepoints
• Change from baseline in EORTC QLQ-C30 scale scores
• Change from baseline in EORTC QLQ-BR45 scale scores

A Randomised, Multicentre, Double-Blind, Phase III study will evaluate the safety and efficacy of AZD9833 (next generation oral SERD) in combination with palbociclib versus anastrozole in combination with palbociclib for the treatment of patients with ER-positive breast cancer. The goal of the study is to demonstrate superiority of AZD9833 over anastrozole in the context of combination with palbociclib in first line setting.

View this trial on ClinicalTrials.gov