NCT03659136

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

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 Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Xentuzumab	Intravenous infusion
DRUG	Placebo	Intravenous infusion
DRUG	Everolimus	Tablet
DRUG	Exemestane	Tablet

Timeline

• Start date: 2018-11-28
• Primary completion: 2021-08-30
• Completion: 2022-05-11
• First posted: 2018-09-06
• Last updated: 2025-02-24
• Results posted: 2022-09-29

Locations

54 sites across 11 countries: United States, Australia, Belgium, Canada, France, Germany, Greece, Italy, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study