Study type

Study topic

Disease /health condition

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

Enhertu

Study drug International non-proprietary name (INN) or common name

TRASTUZUMAB DERUXTECAN

Anatomical Therapeutic Chemical (ATC) code

(L01FD04) trastuzumab deruxtecan

Medical condition to be studied

HER2 low breast cancer
Population studied

Short description of the study population

Setting:
• 1350 patients from different countries and care settings (primary care and secondary care and different specialties)

The study population consists of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

Age groups

Adult and elderly population (>18 years)
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

1350
Study design details

Study design

Multinational, multicenter, prospective observational, noninterventional study