NCT01702558 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Patients With HER2-Positive Metastatic Breast Cancer and Patients With HER2-Positive Locally Advanced / Metastatic Gastric Cancer (NCT01702558)

Trial Description
This multicenter study will assess the maximum tolerated dose of capecitabine (Xeloda®;Genentech, Inc.) in combination with ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) in patients with HER2-positive metastatic breast cancer and in patients with HER2-positive locally advanced/metastatic gastric cancer using a Phase I design, followed by a randomized, open-label Phase II study to explore the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla in metastatic breast cancer patients. The anticipated time on study treatment is until disease progression, intolerable toxicity, or withdrawal of consent.

This trial is sponsored by F. Hoffmann-La Roche. [1]

Study Data

  • Condition: 
    • Breast Cancer
    • Gastric Cancer
  • Interventions:
  • Phase: II
  • Estimated Enrollment: 235
  • Start: December 2012
  • Estimated Completion: January 2017
  • Last verified: July 2015

Study Schematic

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Last Editorial review: July 30, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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