Status:
RECRUITING
Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Beijing Biostar Pharmaceuticals Co., Ltd.
Hunan Cancer Hospital
Conditions:
Breast Neoplasms
Locally Advanced or Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 Criteria
Inclusion
- 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.
Exclusion
- 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;
- Experienced grade ≥ 3 nervous system-related adverse events after treatment with anti-microtubule drugs;
- Symptomatic central nervous system metastases;
- Pregnant or lactating women;
- Known or suspected hypersensitivity to any of the study drugs or excipients;
- Any other non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that precludes study treatment implementation or follow-up ;
- Any other condition that the investigator considers inappropriate to participate in this trial .
- Use of corticosteroids is prohibited.
Key Trial Info
Start Date :
June 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
349 Patients enrolled
Trial Details
Trial ID
NCT05430399
Start Date
June 21 2022
End Date
June 1 2027
Last Update
July 13 2023
Active Locations (2)
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1
Shusen Wang
Guangzhou, Gangdong, China
2
Hunan Cancer Hospital
Hunan, Hunan, China, 410000