RecruitingPhase 3NCT05430399

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

Sponsor

Sun Yat-sen University

Enrollment

349 participants

Start Date

Jun 21, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms Locally Advanced or Metastatic Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy drugs — utidelone (a newer agent) versus docetaxel (a standard treatment) — in women with HER2-negative advanced breast cancer that has not yet been treated with chemotherapy for their metastatic disease. **You may be eligible if:** - You are a woman aged 18 or older - You have locally advanced or metastatic breast cancer confirmed by biopsy - Your cancer tests HER2-negative - Your cancer has not been treated with chemotherapy in the metastatic setting - Your ECOG performance status is 0 or 1 (active and able to carry out daily activities) - Your cancer is measurable or assessable on imaging - If you received taxane chemotherapy previously, it was at least 12 months ago and was for early-stage disease **You may NOT be eligible if:** - You have had chemotherapy for metastatic breast cancer previously - Your cancer is HER2-positive - You have uncontrolled brain metastases - Your organ function is significantly impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGutidelone

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.

DRUGdocetaxel

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.