111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer

Stopped early · Early Phase 1

Conditions studied: Breast Cancer, Prostate Cancer, Lung Cancer, Colon Cancer

In brief

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.

Key facts

Study ID

NCT01445054

Run by

National Cancer Institute (NCI)

People needed

13

Starts

2007-03-01

Expected to finish

2014-08-20

Last updated by the study team

2019-03-11

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Known allergy to trastuzumab.
• Pregnant or lactating women.
• Participants for whom enrollment would significantly delay (greater than 2 weeks) the scheduled standard of care therapy.
• Participants with an active second malignancy (excluding treated basal cell skin carcinoma).
• History of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis).
• Participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
• Participants with severe claustrophobia.
• A participant who needs a nuclear medicine scan other than a PET scan as part of their work-up cannot enroll until these scans have been completed.
• Gamma-camera table restrictions preclude scanning participants greater than 350 lbs (160 Kg)
• With the exception of AT13387 and PU-H71, and Ad5f35HER2ECTM transduced autologous dendritic cell vaccine participants cannot have received another experimental drug within 14 days prior to or during study enrollment.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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