Table 2.

FDA indication for HER2-targeted agents in breast cancer

Targeted agent	Clinical indication
Trastuzumab [25, 26]	• Adjuvant treatment for HER2 + breast cancer as part of a treatment regimen that includes doxorubicin, cyclophosphamide, and paclitaxel or docetaxel OR part of a treatment regimen with docetaxel and carboplatin OR single agent following anthracycline-based therapy
Pertuzumab [27]	• Metastatic HER2 + breast cancer in combination with trastuzumab and docetaxel for first-line treatment • Adjuvant treatment of early stage HER2 + breast cancer at high risk of recurrence in combination with trastuzumab • Neoadjuvant treatment of locally advanced, inflammatory or early stage HER2 + breast cancer in combination with trastuzumab and chemotherapy
Lapatinib [28]	• Advanced or metastatic HER2 + breast cancer in combination with capecitabine after prior therapy including an anthracycline, a taxane, and Trastuzumab • Metastatic HER2 + , hormone-receptor positive breast cancer in postmenopausal women in combination with letrozole
Neratinib [29]	• Extended adjuvant treatment of early-stage HER2 + breast cancer after adjuvant trastuzumab-based therapy • Advanced/metastatic HER2 + breast cancer in combination with capecitabine after 2 prior anti-HER2 based regimens in metastatic setting
Tucatinib [23]	• Unresectable/metastatic HER2 + breast cancer in combination with Trastuzumab and capecitabine after 1 prior anti-HER2 based regimen
T-DM1 [22]	• Treatment of early-stage HER2 + breast cancer with residual invasive-disease following neoadjuvant taxane and trastuzumab-based treatment • Metastatic HER2 + breast cancer after previous trastuzumab and taxane therapy
Trastuzumab Deruxtecan [18]	• Metastatic HER2 + breast cancer after 2 prior lines of HER2-based regimens in metastatic setting

Abbreviations: HER2 + , Human Epidermal Growth Factor Receptor 2 Positive; LVEF, left ventricular ejection fraction; T-DMI, Trastuzumab Emtansine