(duplicate) LidERA

• Research type

  Research Study

• Full title

  A PHASE III, RANDOMIZED, OPEN-LABEL,MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTORPOSITIVE, HER2-NEGATIVE EARLY BREAST CANCER.

• IRAS ID

  305857

• Contact name

  Melissa Phillips

• Contact email

  melissa.phillips5@nhs.net

• Eudract number

  2021-000129-28

• Clinicaltrials.gov Identifier

  NCT04961996

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  11 years, 10 months, 28 days

• Research summary

  This is a Phase III, global, randomized, open-label, multicenter study evaluating the efficacy and safety of giredestrant compared with the Therapy of Physician's Choice (TPC) of Adjuvant Endocrine drugs currently available for patients with certain types of breast cancer (Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer). Patients will be treated daily with giredestrant or the TPC of Adjuvant Endocrine drugs for at least 5 years. Patients will need to attend hospital/clinical visits and undergo a number study procedures/tests. During the study, patients will be regularly assessed for efficacy, safety, and health-related quality of life. Patients who complete the 5-year study treatment will enter long-term follow-up for at least 5 years.
  Patients will be randomly assigned in a 1:1 ratio to one of the following treatment arms: Arm A (experimental arm): giredestrant 30 mg once a day, or Arm B (control arm): TPC dosing according to local prescribing information Endocrine Therapy of Physician’s Choice is limited to tamoxifen, anastrozole, letrozole, or exemestane. Approximately 4700 participants will be screened to achieve an estimated 4100 randomized participants for a total of 2050 randomized participants per treatment group.
  The total duration of study participation for each individual is expected to be approximately 10 years (5 years of treatment followed by 5 years of follow-up).

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  21/WM/0261

• Date of REC Opinion

  20 Dec 2021

• REC opinion

  Further Information Favourable Opinion