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. 2023 Apr 19;18(3):327–358. doi: 10.1007/s11523-023-00957-7

Table 2.

Included clinical study characteristics

Characteristic Number of studies
Total 87
Publication type
Full journal article 71
Abstract 13
Clinicaltrials.gov record 3
Study type
Clinical trial 12
Observational (retrospective) 66
Observational (prospective) 6
Observational (prospective-retrospective) 3
Year of data collection end
Pre-2015 0
2015–16 4
2017–18 32
2019–20 36
2021–current 12
NR 3
Region of investigation
Europe 14
North America 36
South America 3
Asia 23
International 6
NR 5
Breast cancer subtype
Early BC 0
Metastatic BC 87
HR+/HER2−a 83
HR+/HER2+a 1
HR−/HER2+ 0
HR−/HER2− 0
ER+ (HER2 status not specified) 1
NR (metastatic but subgroup not specified) 2
Metastatic breast cancer typeb
De novo 20
Recurrent 11
Distant metastases 3
NR 70
Number of metastatic sitesb
< 3 18
≥ 3 19
NR 69
Visceral/bone diseaseb
Visceral disease 45
Bone/bone marrow only 43
NR 34
CDK4/6i line of therapy
1L only 1
2L only 5
3L+ only 0
Multiple linesc 73
1L+ 62
2L+ 11
3L+ 0
NR/reported post-CDK4/6i only 8
Post-CDK4/6i therapy evaluatedb
ET only 26
CT only 24
mTORi-based only 12
CDK4/6i-based only 16
Combination of mTORi- and CDK4/6i-based therapies 1
Regimen unspecifiedd 11
NR 41

# number of lines of therapy, 1L first line, 2L second line, 3L third line, CDK4/6i cyclin-dependent kinase 4/6 inhibitor, CT chemotherapy, ER estrogen receptor, ET endocrine therapy, HER2 human epidermal growth factor receptor 2, HR hormone receptor, mBC metastatic breast cancer, mTORi mammalian target of rapamycin inhibitor, NR not reported

aHR+ includes studies reported as ER+ only

bStudies that reported characteristic for multiple categories were counted in each category

cStudies were grouped into the most appropriate category; groups are mutually exclusive. For example, a study reported CDK4/6i in 1L, 2L, and 3L+ settings would be counted as 1L+

dIncluding targeted therapy, best supportive care, and investigational drugs