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

ConditionsBreast NeoplasmsLocally Advanced or Metastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSun Yat-sen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Signed the informed consent form;

Women aged ≥ 18 years;

Patients with locally advanced or metastatic, histologically or cytologically documented breast cancer;

The primary tumor and metastases (if re-biopsy was performed) were both HER2-negative;

Disqualifiers

HER-2 positive (IHC 3+, or FISH positive);

Other malignancies (including primary brain or leptomeninges-related tumors) within the past 5 years, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ;

Patients who have received anti-tumor therapy within 4 weeks prior to the start of study treatment, including chemotherapy, radical radiotherapy, biological therapy, immunotherapy or anti-tumor Chinese medicine therapy;

Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks before the first dose of treatment, or anticipating for a major surgical procedure during the study;

Trial design

Design model

Parallel

Treatments tested in this trial

  • utidelone

    Drug

    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.

  • docetaxel

    Drug

    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.

Treatment groups

349 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

Time from randomization to progression or death (whichever occurred first)

Time frame
up to 60 months

Secondary outcomes

1

Objective response rate (ORR)

The proportion of patients with a best response of CR or PR, according to RECIST 1.1 criteria

Time frame
up to 60 months
2

Time to response (TTR)

the time from randomization to the first documentation of disease response (CR or PR)

Time frame
up to 60 months
3

Duration of response (DOR)

the time from the first evaluation that criteria for CR or PR are met until PD or death is observed, whichever occurs first, calculated only for patients whose best response is evaluated as CR or PR.

Time frame
up to 60 months
4

Overall survival (OS)

Time from randomization to death Time from randomization to death Time from randomization to death Time from randomization to death

Time frame
up to 60 months

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Beijing Biostar Pharmaceuticals Co., Ltd.

Collaborator

Hunan Cancer Hospital

Collaborator

Source ClinicalTrials.gov
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