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 type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01EF02) ribociclib

  ribociclib

  (L02BA03) fulvestrant

  fulvestrant

  (L02BG04) letrozole

  letrozole
• Additional medical condition(s):
  Advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer

Population studied

• Age groups:
  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  812

Study design details

• Main study objective:
  The objective of this study was to perform a comprehensive analysis of real-world data (RWD) from the Bulgarian population.
• Outcomes:
  Clinical benefit rate (CBR, defined as complete remission [CR] or partial remission [PR] or stable disease [SD]), progression-free survival (PFS) and overall survival (OS).