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Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer

NCT05430399 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 349

Last updated 2023-07-13

No results posted yet for this study

Summary

It is a phase III trial to explore the efficacy and safety of utidelone versus docetaxel in HER2-negative locally advanced or metastatic breast cancer.

Conditions

Interventions

DRUG

utidelone

Eligible patients will receive treatment with utidelone(40 mg/ m2 /day, D1-5,Q3W) , treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration.

DRUG

docetaxel

Eligible patients will receive treatment with docetaxel (75mg/ m2/day, D1, Q3W) , treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration.

Sponsors & Collaborators

  • Beijing Biostar Pharmaceuticals Co., Ltd.

    collaborator INDUSTRY

  • Hunan Cancer Hospital

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2025-06-01
Completion
2027-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05430399 on ClinicalTrials.gov