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).
Documents