Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer

Korábbi kezelés

• Participants who have received trastuzumab within the prior 36 days
• Concurrent malignancy other than skin cancer - Inability to provide informed consent

Egyéb

• Participants who are not considered candidates for ado-trastuzumab-emtansine
• No metastatic sites >= 20 mm

• Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla; biopsy must be obtained prior to initiation of chemotherapy; it should be performed within 28 days prior to enrollment (patients with a biopsy of recurrent disease that is HER2-positive and have not received HER2-directed therapy since the biopsy can exceed the 28-day window up to 6 months); patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible)
• At least 1 site of metastasis >= 20 mm in mean diameter must be identified
• The cancer must over express HER2 as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH)
• Patients may not have received trastuzumab within 6 weeks of projected 64Cu-DOTA-trastuzumab/PET-CT
• Participants must have normal cardiac ejection fraction
• Ability to provide informed consent
• Patients that may need dose reduction to commence cycle 1 treatment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Negative serum pregnancy test (female of childbearing potential only)
• Patients must have adequate cardiac function; left ventricular ejection fraction (LVEF) >= 50% as determined by multi gated acquisition (MUGA) scan or echocardiogram