Statement: Female patients over the age of 60, with Histologically confirmed breast cancer and advanced Alzheimer's disease are ineligible for both the secondary trial and the primary trial.
Primary_evidence: Inclusion Criteria:   All study patients must have histologically confirmed invasive adenocarcinoma of the breast. Their breast cancer must be resectable clinical stage I or II breast cancer as defined by the current AJCC TNM Staging System (Greene FL, Page DL, Fleming ID, et al.: editors. AJCC cancer staging manual, 6th edition. New York: Springer; 2002).   All patients must be able to and give informed consent indicating they are aware of the investigational nature of this treatment, prior to entry into the study.   All subjects must be Age >18 years.   All subject must have adequate hepatic and renal function documented prior to study entry to include: hepatic transaminases (AST or ALT)  1.5 times the upper limits of normal, total bilirubin  1.5 times the upper limits of normal, serum creatinine  1.5 times the upper limit of normal or eCRCl  60 mL/min. Exclusion criteria:   Patients who have received prior or be receiving radiation therapy for their breast cancer will be excluded.   Patients who have received prior chemotherapy or receiving chemotherapy or hormonal therapy for their breast cancer will not be included.   Women must be surgically sterilized or post-menopausal or women of childbearing potential must be using an adequate method of contraception. Women of childbearing potential must be using at least one of the following: oral, implanted, injectable contraceptive hormones, or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or have a partner that is sterile (e.g., vasectomy). Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study therapy. Women who are pregnant or breast-feeding and women of childbearing potential not using an adequate method of birth control will be excluded.   Patients with gastrointestinal abnormalities including: inability to take oral medication, requirement for intravenous alimentation, or prior surgical procedures affecting nutrient /drug absorption will be excluded.   A serious uncontrolled medical disorder or active infection which would impair their ability to receive study treatment will be excluded. Significant cardiac disease, including uncontrolled high blood pressure, unstable angina, and congestive heart failure, myocardial infarction within the previous 3 months or serious cardiac arrhythmias will be excluded. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol will be excluded.
Secondary_evidence: Inclusion Criteria:   Females  18 years of age   Histologically confirmed breast cancer that is HER2/neu positive (3+ by IHC or FISH +) and evidence of metastatic disease. Tumor may be of any estrogen and progesterone receptor type   Measurable disease by RECIST and an ECOG  2   Patients with known evidence of brain metastases are eligible if they are asymptomatic and have completed all therapy (surgery, radiotherapy, and/or steroids)   Baseline LVEF value within the institutional normal range   Any number of prior hormonal therapy treatments in the adjuvant setting or for metastatic disease. A subject must have progressed on hormonal therapy and all hormonal therapy (including birth control pills) must be discontinued at study entry.   Prior chemotherapy in the adjuvant setting and up to one prior chemotherapy regimen for metastatic disease is allowed.   Patients may have received one prior trastuzumab/chemotherapy containing regimen or prior single agent trastuzumab.   Prior radiation therapy in the adjuvant setting or for metastatic disease, provided it was not to the only site of evaluable disease.   All prior chemotherapy, trastuzumab and radiation therapy should be completed > 2 weeks before enrollment.   Patients receiving bisphosphonate therapy are eligible. However, if bisphosphonate were started within < 2 months prior to enrollment, the bone lesions will not be evaluated for response and the patient must have another site of metastatic disease that is either measurable or evaluable for response.   Patients must have recovered from toxicities due to prior therapy.   Lab values in accordance with the protocol   Patients must be nonpregnant and nonlactating. Patients of childbearing potential must implement an effective method of contraception during the study (birth control pills are not allowed). Exclusion Criteria:   Bone only disease are ineligible   Patients who received more than 1 prior chemotherapy regimen for metastatic disease are ineligible.   Patients with a history of other cancers except curatively-treated carcinoma of the cervix in situ or non-melanomatous skin cancer.   Active serious infection or other underlying medical condition that would impair their ability to receive protocol treatment.   Uncontrolled nervous system metastases   Dementia or significantly altered mental status that would interfere with proper consenting.   Receiving other investigational therapy.