TheranosticTrials.org

Clinical Trial · NCT01445054

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

Overview

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.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases

Phase

Early Phase 1

Contacts

Peter L Choyke, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01445054

Drug / Compound

trastuzumab

Isotope(s):
Target(s):
  • HER2
Ligand Class: Antibodies
Chelator: CHX-A DTPA

Eligibility

Inclusion

  • Availability of tumor tissue (either from the initial primary tumor or from current tumor lesion) for performing IHC or FISH analysis for HER2/Neu (Erb2)
  • Chemistry and CBC parameters: serum creatinine less than or equal to 1.4mg/dl. SGOT and SGPT less than or equal to 3 times of the upper limits of normal; total bilirubin, of less than or equal to 2 times the upper limits of normal or 3.0 mg/dl in patients with Gilbert s syndrome; platelet count must be greater than 100,00.
  • Primary tumor or metastatic focus must be 1.5cm or greater in diameter as established by palpation, ultrasound, mammography, CT or MRI.
  • ECOG Performance score of 0 or 1.

Exclusion

  • 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.
  • 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.
  • 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.
  • Pregnant or lactating women.
  • Participants with an active second malignancy (excluding treated basal cell skin carcinoma).
  • Participants with severe claustrophobia.
  • Gamma-camera table restrictions preclude scanning participants greater than 350 lbs (160 Kg)
  • Participants for whom enrollment would significantly delay (greater than 2 weeks) the scheduled standard of care therapy.
  • Known allergy to trastuzumab.