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NCT01745965 (Clinical Trial / Ado-Trastuzumab Emtansine)

Study Title
A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Trastuzumab Emtansine (T-DM1) With or Without Standard Endocrine Therapy vs. Trastuzumab With Standard Endocrine Therapy Given for Twelve Weeks in Patients With Operable HER2+/HR+ Breast Cancer Within the ADAPT Protocol. (ADAPT; T-DM1 (NCT01745965)

Trial Description
Trial to optimize neoadjuvant therapy for HER overexpression and co-expressing of hormone receptors(ER and/or PR) breast cancer (HEr2+/HR+).

A new high potential trastuzumab conjugate ado-trastuzumab emtansine (T-DM1) (Kadcyla®; Genentech, Inc.) (trastuzumab was linked with the cytotoxic agent mertansine DM1) was tested with endocrine therapy and without against a standard arm with trastuzumab and endocrine therapy.

This trial is sponsored by West German Study Group / F. Hoffmann-La Roche Ltd. [1]

Study Data

  • Condition: Breast Cancer
  • Interventions:
    • Drugs used in this trial
  • Phase: II
  • Estimated Enrollment: 380
  • Start: November 2012
  • Estimated Completion: October 2020
  • Last verified: June 2015

Study Schematic

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

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