Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA)
NCT06510465 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143
Last updated 2024-07-19
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.
Conditions
Interventions
- DRUG
-
utidelone
utidelone 50mg/m2,ivgtt,d1,8,15,22, q28d, up to 4 cycle;
- DRUG
-
cisplatin25mg/m2,ivgtt,d1,8,15;q28d, up to 4 cycle.
- DRUG
-
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 840mg, ivgtt, d1, then 420mg, q21d or Pertuzumab/trastuzumab/hyaluronidase
Sponsors & Collaborators
-
RenJi Hospital
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-01
- Primary Completion
- 2027-03-31
- Completion
- 2032-03-31
Countries
- China
Study Locations
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