Recruiting NCT05430399
Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: utidelone, docetaxel.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer : A Phase III, Open Label, Randomized Controlled Trial
Overview
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.
Interventions
- Drug utidelone
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. - Drug docetaxel
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.
Primary outcome measures
- Progression Free Survival (PFS) [Time frame: up to 60 months]
Secondary outcome measures (5)
- Objective response rate (ORR) [Time frame: up to 60 months]
- Time to response (TTR) [Time frame: up to 60 months]
- Duration of response (DOR) [Time frame: up to 60 months]
- Overall survival (OS) [Time frame: up to 60 months]
- Patient-reported health-related quality of life (QoL): FACT-B total score [Time frame: up to 60 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Shusen Wang — Guangzhou
- Hunan Cancer Hospital — Hunan
Identifiers
NCT: NCT05430399 · SYSU-2022-UCAN