Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05430399

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

Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer : A Phase III, Open Label, Randomized Controlled Trial

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
349 (estimated)
Sponsor
Sun Yat-sen University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
DRUGutideloneEligible 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.
DRUGdocetaxelEligible 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.

Timeline

Start date
2022-06-21
Primary completion
2025-06-01
Completion
2027-06-01
First posted
2022-06-24
Last updated
2023-07-13

Locations

2 sites across 1 country: China

Source: ClinicalTrials.gov record NCT05430399. Inclusion in this directory is not an endorsement.