HER2 in breast cancer
27 EU-approved indications in breast cancer need a HER2 result: trastuzumab (3rd line+, metastatic), trastuzumab (1st line, metastatic), trastuzumab (1st line, metastatic), trastuzumab (metastatic), trastuzumab (adjuvant, early), trastuzumab (adjuvant, early), trastuzumab (adjuvant, early), trastuzumab (neoadjuvant), trastuzumab (adjuvant), trastuzumab deruxtecan (1st line, advanced), trastuzumab deruxtecan (2nd line, advanced), trastuzumab deruxtecan (2nd line, advanced), trastuzumab deruxtecan (2nd line, advanced), pertuzumab (neoadjuvant), pertuzumab (adjuvant, early), pertuzumab (1st line, advanced), datopotamab deruxtecan (1st line, advanced), trastuzumab emtansine (adjuvant, early), trastuzumab emtansine (2nd line, advanced), lapatinib (2nd line, advanced), lapatinib (2nd line, metastatic), lapatinib (metastatic), tucatinib (3rd line+, advanced), pertuzumab + trastuzumab (neoadjuvant), pertuzumab + trastuzumab (adjuvant, early), pertuzumab + trastuzumab (1st line, advanced) and neratinib (adjuvant, early).
Disease setting
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| ER/PR/HER2 negative1 | ||||
Datroway | Triple-negative (ER-negative, PR-negative, HER2-negative) | Monotherapy | 1L advanced | Not candidates for PD-1/PD-L1 inhibitor therapy |
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| HER226 | ||||
Perjeta | IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and chemotherapy | Neoadj. | Locally advanced, inflammatory, or early stage; high risk of recurrence |
Phesgo | IHC 3+ or IHC 2+/ISH-positive | + chemotherapy | Neoadj. | Locally advanced, inflammatory, or early stage; high risk of recurrence |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | + neoadjuvant chemotherapy | Neoadj. | Then adjuvant monotherapy after surgery; Locally advanced (including inflammatory) disease or tumours > 2 cm in diameter |
Nerlynx | IHC 3+ or IHC 2+/ISH-positive, HR-positive | Monotherapy | Adj. early | After adjuvant trastuzumab-based therapy completed less than one year ago |
Perjeta | IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and chemotherapy | Adj. early | High risk of recurrence |
Phesgo | IHC 3+ or IHC 2+/ISH-positive | + chemotherapy | Adj. early | High risk of recurrence |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | + docetaxel and carboplatin | Adj. early | None |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | + paclitaxel or docetaxel | Adj. early | After adjuvant chemotherapy with doxorubicin and cyclophosphamide |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adj. early | Following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adj. | After neoadjuvant Herceptin + chemotherapy and surgical resection; Locally advanced (including inflammatory) disease or tumours > 2 cm in diameter |
Kadcyla | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adj. early | After neoadjuvant taxane-based and HER2-targeted therapy; Residual invasive disease, in the breast and/or lymph nodes |
Perjeta | IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and docetaxel | 1L advanced | No prior anti-HER2 therapy or chemotherapy for metastatic disease |
Phesgo | IHC 3+ or IHC 2+/ISH-positive | + docetaxel | 1L advanced | No prior anti-HER2 therapy or chemotherapy for metastatic disease |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | + docetaxel | 1L metastatic | None |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | + paclitaxel | 1L metastatic | Anthracycline is not suitable |
Enhertuconditional | IHC 3+ or IHC 2+/ISH-positive | + pertuzumab | 1L advanced | None |
Tyverb | IHC 3+ or IHC 2+/ISH-positive | + capecitabine | 2L advanced | Progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting |
Tyverb | IHC 3+ or IHC 2+/ISH-positive, HR-negative | + trastuzumab | 2L metastatic | Progressed on prior trastuzumab therapy(ies) in combination with chemotherapy |
Enhertuconditional | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2L advanced | After one or more prior anti-HER2-based regimens |
Enhertuconditional | IHC 1+ or IHC 2+/ISH-negative or IHC 0 with membrane staining (faint, incomplete, ≤10% of tumour cells), HER2-low or HER2-ultralow, HR-positive | Monotherapy | 2L advanced | After at least one endocrine therapy in the metastatic setting; Not considered suitable for endocrine therapy as the next line of treatment |
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 |
Kadcyla | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2L advanced | After prior trastuzumab and a taxane, separately or in combination; and either prior therapy for locally advanced or metastatic disease, or disease recurrence during or within six months of completing adjuvant therapy |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 3L+ metastatic | After at least two prior chemotherapy regimens for metastatic disease including an anthracycline and a taxane (unless unsuitable); failed hormonal therapy for hormone receptor-positive disease (unless unsuitable) |
Tukysa | IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and capecitabine | 3L+ advanced | After at least 2 prior anti-HER2 treatment regimens |
Tyverb | IHC 3+ or IHC 2+/ISH-positive, HR-positive | + an aromatase inhibitor | Any line metastatic | Postmenopausal women; not currently intended for chemotherapy |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive, HR-positive | + aromatase inhibitor | Any line metastatic | No prior trastuzumab; Postmenopausal |
Tumour-agnostic approvals1
Approved for any solid tumour that carries the alteration, wherever the tumour started.
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| HER21 | ||||
Enhertuconditional | HER2-positive (IHC 3+) | Monotherapy | 2L advanced | After prior treatment; No satisfactory treatment options |
See also
Label wording27
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Trastuzumab (Herceptin, Tuznue)
as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
- Trastuzumab (Herceptin, Tuznue)
in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.
- Trastuzumab (Herceptin, Tuznue)
in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
- Trastuzumab (Herceptin, Tuznue)
in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.
- Trastuzumab (Herceptin, Tuznue)
following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
- Trastuzumab (Herceptin, Tuznue)
following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
- Trastuzumab (Herceptin, Tuznue)
in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
- Trastuzumab (Herceptin, Tuznue)
in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).
- Trastuzumab (Herceptin, Tuznue)
in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).
- Trastuzumab deruxtecan (Enhertu)
Enhertu in combination with pertuzumab is indicated for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (for biomarker-based patient selection, see section 4.2).
- Trastuzumab deruxtecan (Enhertu)
Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
- Trastuzumab deruxtecan (Enhertu)
• hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment (see sections 4.2 and 5.1).
- 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).
- Pertuzumab (Perjeta)
the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)
- Pertuzumab (Perjeta)
the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)
- Pertuzumab (Perjeta)
Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
- 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).
- Trastuzumab emtansine (Kadcyla)
Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.
- Trastuzumab emtansine (Kadcyla)
Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
- Lapatinib (Tyverb)
in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1).
- Lapatinib (Tyverb)
in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy (see section 5.1).
- Lapatinib (Tyverb)
in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy.
- Tucatinib (Tukysa)
TUKYSA is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens.
- Pertuzumab + trastuzumab (Phesgo)
the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)
- Pertuzumab + trastuzumab (Phesgo)
the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)
- Pertuzumab + trastuzumab (Phesgo)
Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
- Neratinib (Nerlynx)
Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.