HER2 in triple-negative breast cancer

2 EU-approved indications in triple-negative breast cancer need a HER2 result: trastuzumab deruxtecan (2nd line, advanced) and datopotamab deruxtecan (1st line, advanced).

Line of therapy

Approved indications, Triple-negative breast cancer
DrugBiomarker requirementRegimenSettingConditions
HER2-low1
Trastuzumab deruxtecan
Enhertuconditional
IHC 1+ or IHC 2+/ISH-negative, HER2-low
Monotherapy
2L
advanced
After prior chemotherapy in the metastatic setting or disease recurrence during or within 6 months of completing adjuvant chemotherapy
ER/PR/HER2 negative1
Triple-negative (ER-negative, PR-negative, HER2-negative)
Monotherapy
1L
advanced
Not candidates for PD-1/PD-L1 inhibitor therapy

Tumour-agnostic approvals1

Approved for any solid tumour that carries the alteration, wherever the tumour started.

DrugBiomarker requirementRegimenSettingConditions
HER21
Trastuzumab deruxtecan
Enhertuconditional
HER2-positive (IHC 3+)
Monotherapy
2L
advanced
After prior treatment; No satisfactory treatment options

4 approvals for TNBC need no biomarker and apply whatever the result. All approvals for TNBC

See also

Label wording2

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Trastuzumab deruxtecan (Enhertu)
    • 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 (see section 4.2).
  2. Datopotamab deruxtecan (Datroway)
    Datroway as monotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy (see section 5.1).