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NCT01772472 (KATHERINE) (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) (NCT01772472)

Trial Description
This 2-arm, randomized, open-label study will evaluate the efficacy and safety of ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) versus trastuzumab (Herceptin®; Genentech, Inc.) as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.

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

Study Data

  • Condition: Breast Cancer
  • Interventions:
  • Phase: III
  • Estimated Enrollment: 1484
  • Start: April 2013
  • Estimated Completion: March 2023
  • 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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