Utidelone Versus Docetaxel in HER2-negative Locally 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
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
Treatments tested in this trial
- utidelone
- docetaxel
Treatment groups
349 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sun Yat-sen University
Lead sponsor
Beijing Biostar Pharmaceuticals Co., Ltd.
Collaborator
Hunan Cancer Hospital
Collaborator
Source ClinicalTrials.gov