NCT05953168

T-DXd in the First-Line Treatment of Locally Advanced or Metastatic TNBC-LAR HER2-low Patients

An Open-label, Single-arm Phase II Trial of First-line Treatment With Trastuzumab Deruxtecan for Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer, Luminal Androgen Receptor Subtype With Low Human Epidermal Growth Factor Receptor 2 (HER2) Expression.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm phase II trial of first-line treatment with trastuzumab deruxtecan (T-DXd) for patients with locally advanced or metastatic triple-negative breast cancer, luminal androgen receptor subtype (TNBC-LAR) with low HER2 expression.

Conditions

• Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab Deruxtecan	Trastuzumab Deruxtecan for TNBC-LAR patients with HER2 low expression

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-08-01
• Completion: 2026-08-01
• First posted: 2023-07-19
• Last updated: 2023-07-19

Locations

1 site across 1 country: China