NCT06510465

Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA)

Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA): A Multi-center, Prospective Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multi-center, single-arm, two-cohort, exploratory study, aiming to explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in breast cancer patients.

Detailed description

Explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in high risk early, locally advanced and Inflammatory breast cancer patients.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	utidelone	utidelone 50mg／m2，ivgtt，d1，8，15，22, q28d, up to 4 cycle；
DRUG	Cisplatin	cisplatin25mg/m2，ivgtt，d1，8，15；q28d, up to 4 cycle.
DRUG	Trastuzumab	Trastuzumab 8mg/kg, ivgtt, d1, then 6mg/kg, q21d or Trastuzumab 4mg/kg, ivgtt, d1, then 2mg/kg, q7d or Trastuzumab Injection（Subcutaneous Injection）600mg，subcutaneous Injection，d1，q21d
DRUG	Pertuzumab	Pertuzumab 840mg, ivgtt, d1, then 420mg, q21d or Pertuzumab/trastuzumab/hyaluronidase

Timeline

• Start date: 2024-08-01
• Primary completion: 2027-03-31
• Completion: 2032-03-31
• First posted: 2024-07-19
• Last updated: 2024-07-19

Locations

2 sites across 1 country: China