NCT02038010 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx (NCT02038010)

Trial Description
The purpose of this study is to see whether a combination of two different drugs – ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) and BYL719 is safe, and if it might be effective in treating metastatic breast cancer. T-DM1 is a type of drug that contains an antibody (trastuzumab) linked to chemotherapy. The antibody in T-DM1 targets a marker on breast cancer cells called HER2, which allows the drug to go directly to the cancer cells. The use of T-DM1 in this study is considered standard treatment for the type of cancer in this study. Participants in this study have already been treated with trastuzumab and chemotherapy in the past, and their cancer has gotten worse in spite of those treatments. BYL719 is an oral drug (taken by mouth) that the researchers think may help T-DM1 to work better.

This trial is sponsored by Northwestern University. [1]

Study Data

  • Condition: 
    • HER2-positive Breast Cancer
    • Recurrent Breast Cancer
    • Stage IIIA Breast Cancer
    • Stage IIIB Breast Cancer
    • Stage IIIC Breast Cancer
    • Stage IV Breast Cancer
  • Interventions:
    • Drugs used in this trial
    • Other: pharmacological study
    • Other: laboratory biomarker analysis
  • Phase: I
  • Estimated Enrollment: 28
  • Start: February 2014
  • Estimated Primary Completion: November 2017
  • Last verified: April 2015

Study Schematic

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Last Editorial review: July 28, 2015
Information based on (NIH/NCI) and other sources.

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