Trastuzumab Deruxtecan With or Without Neratinib for HER2-positive Unresectable and/or Metastatic Breast Cancer With Brain Metastasis: A Multicenter, Randomized, Open Label, Phase II Trial (THUNDER Trial)

NCT07152782 Phase 2 NOT_YET_RECRUITING

A phase II, open-label, multicenter, randomized controlled trial exploring the efficacy and safety of Trastuzumab Deruxtecan combined with or without Neratinib in HER2-positive breast cancer with brain metastasis

Details

Lead sponsor	Fudan University
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	202
Start date	2025-11
Completion	2029-11

Conditions

• Breast Cancer With Brain Metastasis
• HER2-positive Breast Cancer

Interventions

• Neratinib
• Trastuzumab Deruxtecan

Primary outcomes

• Progression Free Survival(PFS) — 24 months
  Time to progressive disease (according to RECIST1.1)