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Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02)

Trial Profile

Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2025

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At a glance

  • Drugs Tucatinib (Primary) ; Trastuzumab emtansine
  • Indications Advanced breast cancer; Brain metastases; Carcinoma; HER2 positive breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms HER2CLIMB-02
  • Sponsors Pfizer; Seagen

Most Recent Events

  • 29 May 2025 Planned End Date changed from 28 Oct 2027 to 10 Mar 2029.
  • 30 Apr 2025 Results evaluating efficacy and safety and pharmacokinetics of tucatinib in combination with T-DM1 versus placebo in combination with T-DM1 presented at the 116th Annual Meeting of the American Association for Cancer Research.
  • 22 Apr 2025 Planned End Date changed from 31 Oct 2027 to 28 Oct 2027.

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