NCT02236000 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer (NCT02236000)

Trial Description
This study is being done for the following reasons:

The study has two parts. The purpose of the first part (Phase I) of the study is to find out the highest dose of neratinib that can be given safely with ado-trastuzumab emtansine (T-DM1) (Kadcyla®; Genentech, Inc.).
The purpose of the second part of the study (Phase II) is to find out whether the dose of neratinib with T-DM1 determined in Phase I will keep breast cancer from getting worse for a period of time.
In order to learn more about study therapy levels in blood and discover genetic and protein changes associated with cancer, the study includes special research tests using samples from blood and from breast tumor. Blood samples will be collected before study treatment, once during treatment, and after study treatment stops.
In the optional part of this study, three biopsies will be performed to obtain fresh tumor samples from an area where your cancer has spread.

This trial is sponsored by NSABP Foundation Inc./ Puma Biotechnology Inc. [1]

Study Data

  • Condition: Breast Cancer
  • Interventions:
    • Drugs used in this trial
  • Phase: I & II
  • Estimated Enrollment: 63
  • Start: August 2014
  • Estimated Completion: August 2016

Study Schematic

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Last Editorial review: July 27, 2015
Information based on (NIH/NCI) and other sources.

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