NCT06548178

T-DXd Versus THP for Medium-risk HER2-positive Early Breast Cancer

Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Versus Standard Treatment for Medium-risk HER2-positive Early Breast Cancer: a Randomized, Multi-center Trial (EXTEND)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study (EXTEND trial) is a multicentre, interventional, prospective, randomised, open-label, controlled neoadjuvant, phase 2 trial evaluating the efficacy and safety of T-DXd monotherapy vs. standard-of-care docetaxel+ trastuzumab + pertuzumab (THP) in medium-risk (lymph node negative with a primary tumour stage T2) HER2-positive early breast cancer.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	T-DXd	T-DXd (5.4 mg/kg Q3W on Day 1) ×6 cycles.
DRUG	THP	Docetaxel (75 mg/m2 Q3W on Day 1) concurrent with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg Q3W on Day 1) and pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) × 6 cycles.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-09-01
• Completion: 2028-09-01
• First posted: 2024-08-12
• Last updated: 2024-08-12

Locations

1 site across 1 country: China