111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer
Status:
Terminated
Trial end date:
2014-08-20
Target enrollment:
Participant gender:
Summary
Background:
- Some breast cancer cells have specific proteins (receptors) on their surface that make
the tumor grow faster than normal cells. One of these receptors is called HER2/neu.
- An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the
cancer cell.
- Indium-Herceptin is an agent in which a tiny amount of radioactivity called Indium has
been attached to a tiny amount of Herceptin.
Objectives:
-To see if Indium-Herceptin provides information about the characteristics of the breast
cancer in women whose tumors express HER2/neu and those whose tumors do not.
Eligibility:
-Women 18 years or older with primary or metastatic breast cancer who have not received
treatment with herceptin for at least 6 months before enrollment into the study.
Design:
- Tissue from the patient s original breast or tumor biopsy is analyzed for HER2/neu
status.
- Patients have a physical examination and review of medical records.
- Patients receive an injection of Indium-Herceptin, followed by scanning with a gamma
camera that detects the radioactivity in the Indium-Herceptin.
- Patients return to the clinic 1, 2, 3 and 7 days later for repeat imaging to determine
the best time to image after injection of Indium-Herceptin.
- Blood samples are obtained every day of scanning to monitor the effects, if any, of the
Indium-Herceptin and to see how fast the agent leaves the body.