Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Progression Free Survival (PFS) [Срок оценки: up to 60 months]

Вторичные конечные точки (5)

• Objective response rate (ORR) [Срок оценки: up to 60 months]
• Time to response (TTR) [Срок оценки: up to 60 months]
• Duration of response (DOR) [Срок оценки: up to 60 months]
• Overall survival (OS) [Срок оценки: up to 60 months]
• Patient-reported health-related quality of life (QoL): FACT-B total score [Срок оценки: up to 60 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Shusen Wang — Гуанчжоу
• Hunan Cancer Hospital — Hunan

Идентификаторы

NCT: NCT05430399 · SYSU-2022-UCAN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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