Subject 006591 was a 56-year-old Ca

Subject 006591 was a 56-year-old Caucasian woman who received neratinib from 12/17/09 to 9/15/10. She was initially diagnosed with TXN1M0 invasive lobular carcinoma in February 2008. She received neoadjuvant TCH (docetaxel, carboplatin, trastuzumab) initiated in March 2008 to an unspecified date. This was followed by mastectomy and radiation therapy. On 9/15/10 she experienced Grade 4 neutropenia that led to study drug discontinuation. Bone marrow biopsy on 10/7/10 revealed acute myeloid leukemia. Per the investigator, the cause of AML was unknown, but possibly related to study drug. According to the CIOMS report (AER #2010US000813), the Sponsor assessed the adverse event of AML to be unrelated to study drugand study procedure. The prior therapy with an alkylating agent had been assessed to have played a contributory role because of a plausible temporal relationship, and the time to onset of AML with reference to the start of neratinib therapy did not suggest a causative relationship.