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.

Titre officiel

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

Sommaire:

L’étude vise à démontrer la supériorité de l’AZD9833 en association avec le palbociclib (un inhibiteur de la kinase dépendante des cyclines 4/6 [KDC 4/6]) par rapport à l’anastrozole (un inhibiteur de l’aromatase) et au palbociclib dans le traitement initial de patientes atteintes d’un cancer du sein avancé/métastatique positif pour les récepteurs hormonaux (RH+) et négatif pour le récepteur 2 du facteur de croissance épidermique humain (HER2-).

Description de l'essai

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.

Voir cet essai sur ClinicalTrials.gov