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

No results posted yet for this study

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

Interventions

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05983094 on ClinicalTrials.gov