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Набор скоро начнётся NCT06795503

Non-Inferiority Study on MRNA-lncRNA Model in Low-Risk Triple-Negative Breast Cancer Patients

Фаза III С лечением Triple-negative Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Docetaxel plus cyclophosphamide, Epirubicin, cyclophosphamide plus paclitaxel.
Кому может быть актуально
Состояния в реестре: Triple-negative Breast Cancer. Базовые параметры: 18 лет — 70 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

To compare the efficacy and safety of different adjuvant chemotherapy regimens for low-risk triple-negative breast cancer patients predicted by mRNA-lncRNA model

Вмешательства

  • Препарат Docetaxel plus cyclophosphamide
    Docetaxel (T) at a dose of 75 mg/m² was administered intravenously on Day 1 of each cycle, and Cyclophosphamide (C) at a dose of 600 mg/m² was administered intravenously on Day 1 of each cycle as well.
  • Препарат Epirubicin, cyclophosphamide plus paclitaxel
    Patients in the control group received the EC-P regimen chemotherapy, with a cycle length of 21 days, for a total of 8 cycles. The specific treatment was as follows: Epirubicin (E) at a dose of 90 mg/m² and Cyclophosphamide (C) at a dose of 600 mg/m² were administered intravenously on Day 1 of each cycle for the first 4 cycles. This was followed by Paclitaxel (P) at a dose of 80 mg/m², administered intravenously on Days 1, 8, and 15 of each cycle for the subsequent 4 cycles.

Первичные конечные точки

  • invasive disease-free survival (iDFS) [Срок оценки: Five years]
Вторичные конечные точки (3)
  • Distant recurrence-free survival (DRFS) [Срок оценки: Five years]
  • Overall survival (OS) [Срок оценки: Five years]
  • Safety according to CTCAE v5.0 (Common Terminology Criteria for Adverse Events, version 5.0) [Срок оценки: Five years]

Критерии участия

Критерии включения

  • Female participants aged ≥18 and ≤70 years.
  • ECOG performance status of 0 to 1.
  • Histologically confirmed invasive triple-negative breast cancer (TNBC), defined as breast cancer with estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) all determined to be negative by pathological testing. Specifically, ER-negative: IHC \<1%, PR-negative: IHC \<1%, HER2-negative: IHC -/+ or IHC++ but FISH/CISH negative. Tissue samples must be verified by the central lead institution as low-risk according to the mRNA-lncRNA model.
  • Postoperative early-stage breast cancer patients who have undergone radical surgery, with pathological TNM staging of pT1c-3N0-3M0.
  • Normal major organ function, meeting the following criteria: ① Hematological examination standards: HB ≥ 90g/L (no blood transfusion within the last 14 days); ANC ≥ 1.5×10⁹/L; PLT ≥ 75×10⁹/L; ② Biochemical examination standards: TBIL ≤ 1.5×ULN (upper limit of normal); ALT and AST ≤ 3×ULN; Serum Cr ≤ 1×ULN, and creatinine clearance rate \> 50ml/min (Cockcroft-Gault formula).
  • Women of childbearing potential must use medically approved contraception during the study treatment period and for at least 3 months after the last dose of the study drug.
  • Participants must voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up procedures.

Критерии исключения

  • Patients who have received neoadjuvant treatment, including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy.
  • Bilateral breast cancer.
  • Metastasis at any site.
  • Any \>T4 lesions (UICC1987) (involving skin invasion, tumor fixation, or inflammatory breast cancer).
  • History of clinically significant or uncontrolled heart disease, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmias.
  • History of other malignancies within the past 5 years, except for cured in situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma of the skin.
  • Pregnant or breastfeeding women, or women of childbearing potential who are unable to use effective contraception.
  • Patients concurrently participating in other clinical trials.
  • Severe or uncontrolled infections.
  • Known active HBV or HCV infection, or HBV DNA ≥ 500, or chronic infection with abnormal liver function.
  • History of substance abuse that cannot be quit or any psychiatric disorders.
  • Patients deemed unsuitable for the study by the investigator.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06795503 · 2407299-27

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗