- Patient has known hypersensitivity to alpelisib, fulvestrant or letrozole
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Patient has received prior treatment with any PI3K inhibitors
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Patient with an established diagnosis of diabetes mellitus type I or uncontrolled type II
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Patient has a concurrent malignancy or malignancy within 3 years of study screening period, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanoma skin cancer or curatively resected cervical cancer
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Patient has received radiotherapy = <4 weeks or limited field radiation for palliation = <2 weeks prior to enrollment, and who has not recovered to grade 1 or better from related side effects of such therapy
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History of acute pancreatitis within 1 year of screening or past medical history of pancreatitis
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Patient with severe liver impairment (Child Pugh score B/C)
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Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs
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Patient has documented pneumonitis which is active and requiring treatment
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Patient has a history of Stevens-Johnson-Syndrome (SJS) or Toxic Epidermal Necroloysis (TEN)
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Patient is concurrently using other anti-cancer therapy. All anti-cancer therapy must be discontinued prior to day one of study treatment.
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Please contact study personnel for more eligibility criteria
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