Akt Inhibitor MK2206 in Treating Patients With Advanced Breast Cancer

Inclusion Criteria

• Patients must have histologically or cytologically confirmed breast cancer, with diagnosed or suspected metastatic, inoperable locally advanced breast cancer, or inoperable locally recurrent breast cancer
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan
• Patients who have failed to respond to at least one line of systemic therapy are eligible for MK2206 therapy; if the patient has a human epidermal growth factor receptor 2 (HER2) positive tumor, it is expected that they will have received at least one HER2-targeted therapy in the metastatic setting; if the patient has an estrogen receptor positive (ER+) tumor, it is expected that they will have received at least one ER-targeted therapy in the metastatic setting; patients can be enrolled for molecular screening while on another therapy if the patient is interested in MK2206 therapy upon progression
• Archived primary tumor biopsies or surgical specimens, or biopsies of recurrence or metastasis, will be available for PIK3CA/Akt mutational analysis and PTEN analysis; patients with surgical samples, or core/punch biopsies available, will be eligible for testing for PIK3CA/Akt status as well as PTEN testing; the most recent sample will be preferred (i.e. in patients with metastatic disease, metastases samples are preferred over archival primary tumor and in patients with local recurrences a biopsy of the recurrence is preferred over archival primary tumor); NOTE: PIK3CA or Akt mutation status can be determined on fine needle aspirate (FNA) samples, but PTEN status cannot as stroma and endothelial cells are used as internal controls and PTEN testing has not been validated on FNA samples; thus patients with only FNA samples and no tissue blocks available will be considered to be eligible for screening for PIK3CA/Akt mutations and will be enrolled onto the study only if they are found to have PIK3CA mutations or Akt mutations; patients whose tumors have already been tested in the Clinical Laboratory Improvement Amendments (CLIA) environment and have been found to have a PIK3CA mutation or Akt mutation or PTEN loss by immunohistochemistry (IHC) or PTEN mutation will be eligible for treatment; patients whose tumors have been tested in the research environment and found to have a PIK3CA mutation or Akt mutation or PTEN loss or PTEN mutation will have their marker status confirmed in the CLIA environment
• Patients whose tumors have already been tested in the CLIA environment and have been found to have a PIK3CA mutation or Akt mutation or PTEN loss or mutation will be eligible for treatment; patients whose tumors have been tested in the research environment and found to have a PIK3CA mutation or Akt mutation or PTEN loss or mutation will have their marker status confirmed in the CLIA environment.
• Patient will have a tumor suitable for FNA and/or core/punch biopsy for research purposes
• Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Absolute neutrophil count (ANC) >= 1,000/uL
• Platelets >= 100,000/uL
• Hemoglobin (Hgb) >= 9 g/dL
• Creatinine = = 6 months life expectancy as documented in patient records

Exclusion Criteria

• Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events to grade 1 or less due to agents administered more than 3 weeks earlier
• Patients may have received prior investigational therapies; however, they not be receiving any other investigational agents concurrent with MK2206; patients must have completed therapy a minimum of 21 days prior to initiation of study therapy
• Patients may not have received treatment