1.1 Adjuvant Breast Cancer

TRAZIMERA is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1)]) breast cancer

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as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel

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as part of a treatment regimen with docetaxel and carboplatin

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as a single agent following multi-modality anthracycline based therapy.

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.1)].

1.2 Metastatic Breast Cancer

TRAZIMERA is indicated:

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In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer

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As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.1)].

1.3 Metastatic Gastric Cancer

TRAZIMERA is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.1)].