NCT01966471 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
A Study of Kadcyla (Trastuzumab Emtansine) Plus Perjeta (Pertuzumab) Following Anthracyclines in Comparison With Herceptin (Trastuzumab) Plus Perjeta and a Taxane Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer (NCT01966471)

Trial Description
This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) in combination with pertuzumab (Perjeta®; Genentech, Inc.) versus trastuzumab (Herceptin®;Genentech, Inc.) in combination with Perjeta and a taxane as adjuvant therapy in patients with HER2-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, patients will receive either Kadcyla 3.6 mg/kg and Perjeta 420 mg intravenously (iv) every three weeks or trastuzumab (Herceptin®;Genentech, Inc.) 6 mg/kg iv every three weeks in combination with Perjeta and a taxane. Anticipated time on HER2 targeted study treatment is up to 1 year.

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

Study Data

  • Condition: Breast Cancer
  • Interventions:
  • Phase: III
  • Estimated Enrollment: 2500
  • Start: January 2014
  • Estimated Completion: September 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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