Adjuvant Albumin-bound Paclitaxel Versus Taxanes in Breast Cancer: a Real-world Study

Официальное название

Adjuvant AC Followed by Albumin-bound Paclitaxel Versus AC Followed by Taxanes in Breast Cancer: a Prospective, Multi-center, Real-world Study

Обзор

This is a prospective, multi-center, real-world study designed to evaluate the efficacy and safety of albumin-bound paclitaxel versus paclitaxel or docetaxel in adjuvant treatment of breast cancer.

Вмешательства

• Препарат doxorubicin
  doxorubicin 50\~60mg/m2, i.v., d1, q3w or q2w.
• Препарат epirubicin
  epirubicin 80\~100mg/m2, i.v., d1, q3w or q2w.
• Препарат pirarubicin
  pirarubicin 40\~50mg/m2, i.v., d1, q3w or q2w.
• Препарат cyclophosphamide
  cyclophosphamide 600mg/m2, i.v., d1, q3w or q2w.
• Препарат albumin-bound paclitaxel
  albumin-bound paclitaxel 260mg/m2, i.v., d1, q3w; 260mg/m2, i.v., d1, q2w; or 125mg/m2, i.v., d1, qw.
• Препарат paclitaxel
  paclitaxel 175mg/m2, i.v., d1, q3w; 175mg/m2, i.v., d1, q2w; or 80mg/m2, i.v., d1, qw.
• Препарат docetaxel
  docetaxel 80\~100mg/m2, i.v., d1, q3w.

Первичные конечные точки

• 5-year invasive disease-free survival (IDFS) rate [Срок оценки: up to 60 months]

Вторичные конечные точки (4)

• IDFS [Срок оценки: up to 60 months]
• overall survival (OS) [Срок оценки: up to 60 months]
• 3-year invasive disease-free survival (IDFS) rate [Срок оценки: up to 36 months]
• Incidence and severity of adverse events [Срок оценки: up to 60 months]

Критерии участия

Критерии включения

• Female patients aged from 18 to 70 years old;
• Histologically confirmed as invasive breast cancer;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Participants achieved complete tumor resection by radical mastectomy, modified radical mastectomy or breast-conserving surgery with negative margins;
• AC-T adjuvant chemotherapy is planned after breast cancer surgery;
• Participants with HER-2 negative breast cancer at high risk of recurrence who meet any of the following conditions: 1) HR positive, and ≥4 positive lymph nodes or 1-3 positive lymph nodes with other risk of recurrence \[such as high Ki67 expression (≥20%), T > 2 cm, age < 35 years, lymphovascular invasion, grade 3 histology\]; 2) HR negative with positive lymph node or T > 2 cm;
• LVEF ≥ 50%;
• Participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form.

Критерии исключения

• In the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1) High-risk uncontrolled arrhythmia, atrial tachycardia (heart rate > 100/min in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 \[Mobitz 2\] atrioventricular block or third-degree atrioventricular block); 2) Angina pectoris requiring anti-angina medication; 3) Clinically significant valvular heart disease; 4) ECG showing transmural myocardial infarction; 5) Uncontrolled hypertension (eg systolic blood pressure > 180mm Hg or diastolic blood pressure > 100mmHg); 6) Myocardial infarction; 7) Congestive heart failure;
• Participants who have received prior any systematic treatment for breast cancer;
• Participants with bilateral invasive breast cancer;
• Breast cancer with distant metastasis;
• Grade 2 or higher Sensory or motor neurotoxicity was present as assessed by CTCAE V5.0;
• Participants have the following serious illnesses or medical conditions, including but not limited: 1) History of serious neurological or psychiatric disorders, including psychosis, dementia, or epilepsy, that prevent understanding and informed consent; 2) Active uncontrolled infection; 3) Active peptic ulcer, unstable diabetes;
• Previous or current existence of other malignant tumors other than breast cancer;
• Severe liver and kidney dysfunction;
• The presence of any myelodysplastic and other hematopoietic disorders;
• Participants who are known to be allergic to the active or other components of the study treatment;
• Participants who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation;
• Participants who were judged by the investigator to be unsuitable for this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Hospital, ChineseAMS — Пекин

Идентификаторы

NCT: NCT05287308 · LQ009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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