Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer
NCT05983094 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 181
Last updated 2023-08-09
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.
Conditions
- Breast Cancer
- Neoadjuvant Therapy
Interventions
- DRUG
-
Utidelone
Utidelone injection 30mg/m2, on days 1-5 of each cycle
- DRUG
-
Carboplatin Area under curve(AUC)6, iv, was administered on day 1
- DRUG
-
Epirubicin
Epirubicin 75mg/m2 was administered on day 1
- DRUG
-
Trastuzumab 8mg/kg iv in first cycle on day 1, then 6mg/kg in the rest cycles
- DRUG
-
Pertuzumab 840mg/kg iv in first cycle on day 1, then 420mg/kg in the rest cycles
Sponsors & Collaborators
-
Chinese Academy of Medical Sciences
collaborator OTHER -
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
collaborator OTHER -
First Affiliated Hospital of China Medical University
collaborator UNKNOWN -
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-01
- Primary Completion
- 2026-09-01
- Completion
- 2027-09-01
Countries
- China
Study Locations
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