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HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg. This extension does not include potential pediatric exclusivity for IBRANCE, that involves substantial risks and uncertainties in the process of drug development and commercialization. IBRANCE when taken in combination with endocrine therapy.