NCT02226276 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer (NCT02226276)

Trial Description
This pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET) works in predicting response to treatment with ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) in patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer that has spread to other places in the body. Copper Cu 64-DOTA-trastuzumab is a chemotherapy drug (trastuzumab (Herceptin®;Genentech, Inc.)) attached to a radioactive substance. Diagnostic procedures using PET may allow scanners to take pictures of where the drug travels in the body and may help doctors identify which patients may benefit from treatment with ado-trastuzumab emtansine.

This trial is sponsored by City of Hope Medical Center [1]

Study Data

  • Condition:
    • Bone Metastases
    • HER2-positive Breast Cancer
    • Liver Metastases
    • Lung Metastases
    • Recurrent Breast Cancer
    • Soft Tissue Metastases
    • Stage IV Breast Cancer
  • Interventions:
    • Drugs used in this trial
    • Radiation: fludeoxyglucose F 18
    • Procedure: positron emission tomography
    • Procedure: computed tomography
    • Radiation: copper Cu 64-DOTA-trastuzumab
    • Other: laboratory biomarker analysis
  • Phase:
  • Estimated Enrollment: 10
  • Start: January 2015
  • Estimated Completion: December 2016
  • Last verified: May 2015

Study Schematic

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Last Editorial review: July 29, 2015
Information based on (NIH/NCI) and other sources.

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