NCT01816035 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
Ado-Trastuzumab Emtansine in Treating Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed by Surgery (NCT01816035)

Trial Description
This phase I trial studies the side effects and best way of giving ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) in treating patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread to other parts of the body or nearby tissue and cannot be removed by surgery. Biological therapies, such as ado-trastuzumab emtansine, may stimulate the immune system in different ways and stop cancer cells from growing.

This trial is sponsored by University of WashingtonNational Cancer Institute (NCI). [1]

Study Data

  • Condition:
    • HER2/Neu Positive Breast Cancer
    • Recurrent Breast Carcinoma
    • Stage IIIB Breast Cancer
    • Stage IIIC Breast Cancer
    • Stage IV Breast Cancer
  • Interventions:
    • Drugs used in this trial
    • Other: Laboratory Biomarker Analysis
    • Other: Pharmacological Study
  • Phase: I
  • Estimated Enrollment: 20
  • Start: June 2014
  • Estimated Primary Completion: February 2016
  • Last verified: June 2015

Study Schematic

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Last Editorial review: July 28, 2015

Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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