Actively Recruiting
Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer
Led by Sun Yat-sen University · Updated on 2023-07-13
349
Participants Needed
2
Research Sites
258 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
B
Beijing Biostar Pharmaceuticals Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed the informed consent form
- Women aged 63; 18 years
- Locally advanced or metastatic breast cancer confirmed by histology or cytology
- Both primary tumor and metastases HER2-negative
- ECOG performance status 0 or 1
- Metastatic disease evaluable by imaging with at least one measurable lesion or non-measurable disease documented by bone scan, PET, or MRI
- Completed prior taxane chemotherapy for early breast cancer at least 12 months before randomization
- No prior chemotherapy for advanced breast cancer
- For HR+ breast cancer, either recurrence/progression within 2 years of adjuvant endocrine therapy or received at least one line of endocrine therapy for recurrence/metastasis
- Recovery to 64; Grade 1 from prior treatment toxicities except alopecia
- Asymptomatic CNS metastases allowed if intracranial lesions are evaluable and meet criteria
- Adequate blood, liver, and kidney function
- Women of childbearing potential agree to use contraception during treatment and for 90 days after last dose
- Life expectancy of at least 12 weeks
- Ability to participate and comply with treatment and follow-up
You will not qualify if you...
- HER2-positive breast cancer (IHC 3+ or FISH positive)
- Other malignancies within past 5 years except cured basal cell carcinoma or cervical carcinoma in situ
- Received any anti-tumor therapy within 4 weeks before study treatment
- Major organ surgery or significant trauma within 4 weeks before treatment or planned major surgery during study
- Experienced grade 63; 3 nervous system side effects from anti-microtubule drugs
- Symptomatic central nervous system metastases
- Pregnant or breastfeeding women
- Known or suspected allergy to study drugs or ingredients
- Any non-malignant systemic disease that prevents treatment or follow-up
- Any condition deemed inappropriate for trial participation by investigator
- Use of corticosteroids is prohibited
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shusen Wang
Guangzhou, Gangdong, China
Actively Recruiting
2
Hunan Cancer Hospital
Hunan, Hunan, China, 410000
Not Yet Recruiting
Research Team
S
shusen wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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