Perlmutter Cancer Center

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Breast Cancer
• Age: Between 18 years - 90 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1) The trial is open to female and male patients. 2) Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease confirmed as described below. Eligible patients include those with either: a) De novo metastatic disease presenting without prior history of HER2-positive breast cancer: - Diagnosis should have been made from a biopsy of a metastatic disease site, but biopsy from the breast primary or involved regional lymph nodes is acceptable if biopsy of the metastatic sites was thought to carry excessive risk for the patient. b) Locally recurrent or metastatic disease following prior therapy for early breast cancer: - Diagnosis must have been made from the biopsy of the locally recurrent or metastatic disease. - There must be an interval of = 6 months between completion of neoadjuvant/adjuvant HER2-targeted therapy and documentation of locally recurrent or metastatic HER2-positive disease by biopsy.
  

You may not be eligible for this study if the following are true:

• 1 Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions: 1) Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met: - Evaluable or measurable disease outside the CNS - No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm) - No history of intracranial hemorrhage or spinal cord hemorrhage - No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted. - No neurosurgical resection or brain biopsy within 28 days prior to randomization. b) Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following: - Radiographic demonstration of improvement upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study - No stereotactic radiation or whole-brain radiation within 4 weeks prior to randomization. - Screening CNS radiographic study at least 4 weeks from completion of radiotherapy and at least 2 weeks from discontinuation of corticosteroids. 2) Known leptomeningeal carcinomatosis. 3) Patients with metastatic disease limited to the CNS.