EMBER-4

• Research type

  Research Study

• Full title

  EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence

• IRAS ID

  1006662

• Contact name

  Elizabeth Heaviside

• Contact email

  EU_lilly_clinical_trials@lilly.com

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2022-501007-28

• Research summary

  Breast cancer is a major cause of morbidity and mortality. In the US, it is estimated that 281,550 female patients and 2,650 male patients were diagnosed with breast cancer in 2021. The estrogen receptor positive (ER+), human epidermal growth factor negative (HER2-) breast cancer type is the most common type, accounting for approximately 70% of all breast cancers and the most deaths from the disease.

  Breast cancer recurrence peaks at 2 years post-surgery; however, there is an ongoing and steady
  risk of recurrence that persists from 5 to 20 years after diagnosis, despite completion of 5 years
  of adjuvant Endocrine hormone Therapy (ET), with more than half of recurrences and deaths from breast cancer occurring after year 5. Unfortunately, despite the effectiveness of ET, a significant number of ER+, HER2- Early Breast Cancer (EBC) patients will experience distant or metastatic recurrence.

  Study EMBER-4 will investigate study medicine imlunestrant treatment vs physician’s choice ET in patients with ER+, HER2- EBC who are at an increased risk of recurrence. Imlunestrant is a selective estrogen receptor degrader (SERDs) that disrupts estrogen signalling, and therefore should stop or slow down tumour growth in ER+ cancers. This study will recruit approximately 6000 participants globally, including around 110 within the UK. Participation in this study will last 10 years. This will include a 5-year treatment phase and a 5-year follow-up phase.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  23/LO/0094

• Date of REC Opinion

  1 Aug 2023

• REC opinion

  Further Information Favourable Opinion