The XENERA™-1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Post-menopausal Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread

Official Title

XENERA™-1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Post-menopausal Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease

Summary:

The main objective of the trial is to assess the anti-tumour activity of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in post menopausal patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.

Trial Description

Primary Outcome:

• Progression free survival (PFS) as assessed by central review

• Overall survival (OS) defined as the time from randomisation until death from any cause
• Disease control (DC)
• Duration of DC is defined as the time from randomisation until the earliest of disease progression or death, among patients with DC
• Objective response (OR) Defined as a best overall response of complete response (CR) or partial response (PR)
• Time to pain progression or intensification of pain palliation

View this trial on ClinicalTrials.gov