NCT05983094

Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 181 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone based regimen as neoadjuvant treatment With High-risk Early-stage or Locally Advanced Breast Cancer.

Detailed description

This is a single arm, multi-center study,three-cohort, prospective phase II study which will enroll 181 high-risk early-stage or locally advanced breast cancer patients.

Conditions

• Breast Cancer
• Neoadjuvant Therapy

Interventions

Type	Name	Description
DRUG	Utidelone	Utidelone injection 30mg/m2, on days 1-5 of each cycle
DRUG	Carboplatin	Carboplatin Area under curve(AUC)6, iv, was administered on day 1
DRUG	Epirubicin	Epirubicin 75mg/m2 was administered on day 1
DRUG	Trastuzumab	Trastuzumab 8mg/kg iv in first cycle on day 1, then 6mg/kg in the rest cycles
DRUG	Pertuzumab	Pertuzumab 840mg/kg iv in first cycle on day 1, then 420mg/kg in the rest cycles

Timeline

• Start date: 2023-09-01
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2023-08-09
• Last updated: 2023-08-09

Locations

1 site across 1 country: China