Lapatinib is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2);

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).

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).

in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor (see sections 4.4. and 5.1)

No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.