evERA

• Research type

  Research Study

• Full title

  A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared with Exemestane Plus Everolimus in Patients with Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

• IRAS ID

  1006280

• Contact name

  Eric Olson

• Contact email

  global.eudract@roche.com

• Sponsor organisation

  Genentech, Inc.

• Eudract number

  2022-000199-20

• Clinicaltrials.gov Identifier

  NCT05306340

• Research summary

  Estrogen Receptor (ER) Positive/Human Epidermal Growth Factor (HER2) Negative is a specific type of breast cancer that is locally advanced or metastatic (has spread to other parts of the body). Breast cancer is the most frequent cancer diagnosed in women, with an estimated global incidence of 2.1 million new cases reported in 2018. Globally, breast cancer accounts for approximately 12% (approximately 627,000 cases) of all cancer deaths.

  The purpose of this study is to compare the effects, good or bad, of giredestrant plus everolimus versus exemestane plus everolimus on patients with ER positive/HER2 negative breast cancer that is locally advanced or metastatic and has returned or worsened after previous treatment. Giredestrant is an experimental drug designed to block the sex hormone called oestrogen that contributes to cancer's growth and progression. Everolimus (Afinitor) is a drug that interrupts the signalling pathway that contributes to the growth and progression of cancer, slowing down the spread of disease. Exemestane (Aromasin) is a drug that blocks the activity of a protein necessary for the production of
  oestrogen in body.

  The study will consist of 3 parts: screening, treatment (multiple cycles with each cycle being 28 days long) and follow up period after treatment completion. There will be 2 treatment arms. Group 1 will receive a giredestrant pill and 1 to 2 everolimus pills, taken by mouth once daily. Group 2 will receive an exemestane pill and 1 to 2 everolimus pills, taken by mouth once daily. Treatment group will be allocated by randomisation. This is an open-label study which means both patient and study doctor will know which group they are placed in. About 320 people will take part in this study worldwide.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  22/NE/0230

• Date of REC Opinion

  24 Jan 2023

• REC opinion

  Further Information Favourable Opinion