Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer : A Phase III, Open Label, Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

• Eastern Cooperative Oncology Group (ECOG) score \[0-1\] points;

• Patients must have metastatic disease that is evaluable on imaging: including at least one measurable lesion (assessed according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)); or only non-measurable disease as defined by RECIST 1.1 , especially in patients with bone metastases only, while the disease could be documented/assessed by bone scan, PET or MRI;

• Previous chemotherapy with taxane for early breast cancer (eBC; neoadjuvant or adjuvant setting) is permitted if completed ≥12 months before randomization;

• No previous chemotherapy for advanced breast cancer ;

• For HR+ breast cancer patients shall meet one of the two criteria below: a) radiographically confirmed recurrence or progression within 2 years of adjuvant endocrine therapy; b) received at least one line of endocrine therapy in the recurrence or metastasis stage;

• Patients must have recovered to ≤ Grade 1 (CTCAE v5.0) from all toxicities related to prior antineoplastic therapy. However, patients with any grade of alopecia were allowed ;

• Patients with asymptomatic CNS metastases may be enrolled, if:

‣ Intracranial lesions are evaluable and eligible for systemic therapy only in the absence of extracranial evaluable lesions, or

⁃ Patients with stable intracranial lesions after local treatment while there are extracranial evaluable lesions ;

• Adequate hematological, hepatic and renal function;

• Women of childbearing potential must agree to use a contraceptive method during the treatment period and for at least 90 days after the last dose of experiment treatment;

• Life expectancy of at least 12 weeks;

• Patients must be able to participate and comply with treatment and follow up.

Locations
Other Locations
China
Shusen Wang
RECRUITING
Guangzhou
Hunan Cancer Hospital
NOT_YET_RECRUITING
Hunan
Contact Information
Primary
shusen wang, MD
wangshs@sysucc.org.cn
+86-020-87342693
Time Frame
Start Date: 2022-06-21
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 349
Treatments
Experimental: Arm A
utidelone
Active_comparator: Arm B
docetaxel
Related Therapeutic Areas
Sponsors
Collaborators: Hunan Cancer Hospital, Beijing Biostar Pharmaceuticals Co., Ltd.
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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