Xentuzumab, Everolimus and Exemestane in metastatic breast cancer.

• Research type

  Research Study

• Full title

  Xenera TM-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.

• IRAS ID

  252601

• Contact name

  Peter Schmid

• Contact email

  p.schmid@qmul.ac.uk

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2017-003131-11

• Clinicaltrials.gov Identifier

  NCT03659136

• Duration of Study in the UK

  2 years, 8 months, 1 days

• Research summary

  This study is known as the Xenera-1 study which is 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. 80 eligible participants are planned to enter the study : 40 receiving Xentuzumab in combination with everolimus and exemestane; and 40 receiving placebo in combination with everolimus and exemestane. Each participant will continue in the trial as as long as the investigator considers they are still benefiting from participating or as long as they do not satisfy any of the withdrawal criteria. Each participant will be required to undergo various blood tests, undergo ECGs, and various imaging techniques to assess tumour response.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  19/NE/0125

• Date of REC Opinion

  13 May 2019

• REC opinion

  Further Information Favourable Opinion