Adequate effectiveness of ribociclib plus letrozole or fulvestrant in patients with advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer treated in routine Bulgarian clinical practice

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000083
• EU PAS number:
  EUPAS1000000083
• Study ID:
  1000000083
• Official title and acronym:
  Adequate effectiveness of ribociclib plus letrozole or fulvestrant in patients with advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer treated in routine Bulgarian clinical practice
• DARWIN EU® study:
  No
• Study countries:
  Bulgaria
• Study description:
  A Real-World Evidence comparison of effectiveness and outcomes of Breast Cancer Targeted Therapy with Randomized Controlled Trials (RCTs) Using Danny Platform.
• Study status:
  Finalised

Research institutions and networks

Institutions

Sqilline Health

Bulgaria

The Bulgarian National Council on Prices and Reimbursement of Medicinal Products (NCPRMP)

Study timelines

Date when funding contract was signed

Planned: 18/01/2023

Actual: 18/01/2023

Study start date

Planned: 01/01/2018

Actual: 01/01/2018

Date of final study report

Planned: 31/12/2022

Actual: 14/04/2023

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable