TREATMENT REGIMEN UTILIZING NERATINIB FOR BREAST CANCER

Provided herein is neratinib or a pharmaceutically acceptable salt or hydrate thereof for use in a method for treating HER-2/neu overexpressed/amplified breast cancer in an extended neratinib adjuvant regimen, wherein the method comprises delivering the extended neratinib adjuvant regimen to a HER-2/neu overexpressed/amplified breast cancer patient, wherein the extended neratinib adjuvant regimen is started at least 2 weeks, at least one month, at least six months or at least nine months following the completion of a trastuzumab adjuvant therapy, and wherein the extended neratinib adjuvant regimen is administered over a period of at least six months, at least 12 months, at least 18 months, 8 months to 5 years or 12 months to three years; wherein the extended neratinib adjuvant regimen improves invasive disease-free survival (IDFS), disease-free survival - ductal carcinoma in situ (DFS-DCIS), distant disease-free survival (DDFS), and/or time to distant recurrence (TTDR) in the patient.