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Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer

ConditionAdvanced Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Biostar Pharmaceuticals Co., Ltd.

About this trial

This study is a randomized controlled study.The primary objective is to evaluate the Progression-Free Survival(PFS) of Utidelone Capsule combined with Capecitabine compared with Utidelone Injection combined with Capecitabine in patients with HER-2 negative advanced breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who have fully understood the objectives, content, process of the study and possible adverse events, voluntarily serves as a subject and signs the informed consent form.

Subjects aged ≥18 and ≤75.

Male or female subjects with ECOG performance status scored 0-1.

Patients who were diagnosed with HER-2 negative advanced breast cancer by histopathology.

Disqualifiers

Patients who have received non-investigational anti-tumor therapies within 4 weeks prior to study drug administration.

Patients who have used Capecitabine or Utidelone within 6 months prior to randomization.

Patients with breast cancer with CNS metastases leptomeningeal metastases.

Patients with uncontrollable bone metastases,existing or recent risk of fracture, recent need for surgery or local radiotherapy, or other critical conditions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Utidelone Capsule

    Drug

    Utidelone Capsule: 60 mg/m2/d, administered once a day orally continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days.

  • Utidelone Injection

    Drug

    Utidelone Injection：30 mg/m2/d, administered once a day intravenously, continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days.

  • Capecitabine

    Drug

    Capecitabine: 1000mg/m2, twice a day continuously for 14 days from day 1 to day 14, with a 21 day treatment cycle.

Treatment groups

308 Participants
are divided into 2 treatment groups
Group A: Utidelone Capsule combined with CapecitabineExperimental treatment 2 interventions
Group B: Utidelone Injection combined with CapecitabineActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival

To evaluate the Progression-Free Survival (PFS) of Utidelone capsules combined with Capecitabine compared with Utidelone Injection combined with Capecitabine

Time frame
6 weeks

Secondary outcomes

1

Objective Response Rate

The percentage of patients who have a partial response or complete response to the treatment.

Time frame
6 weeks
2

Disease Control Rate

The proportion of patients who achieve a complete response , partial response , or stable disease as their best overall response.

Time frame
6 weeks
3

Duration of Response

The time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.

Time frame
6 weeks
4

Time to Treatment Failure

The time from randomization to discontinuation of treatment due to any cause

Time frame
3 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Biostar Pharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: