Pyrotinib in Women With High-risk in Early Stage Breast Cancer

Официальное название

Evaluating the Efficacy and Safety of Pyrotinib After Adjuvant Anti-HRE2 Therapy in Women With High-risk in Early or Locally Advanced Stage Breast Cancer

Обзор

ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached. However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.

Вмешательства

• Препарат Pyrotinib
  Pyrotinib after anti-HER2 therapy（Trastuzumab combined with Pertuzumab or T-DM1）

Первичные конечные точки

• Invasive Disease-free Survival (iDFS) at year 2 [Срок оценки: From enrollment until time of events up to 2 years]

Вторичные конечные точки (4)

• Disease-free Survival at year 2 (2y-DFS) [Срок оценки: From enrollment until time of events up to 2 years]
• Overall Survival (OS) [Срок оценки: Enrollment until death due to any cause, up to 10 years]
• Invasive Disease-free Survival (iDFS) at year 5 [Срок оценки: From enrollment until time of events up to 5 years]
• AEs and SAEs [Срок оценки: From the first administration to one months after the last drug administration]

Критерии участия

Критерии включения

• Subjects voluntarily participate in this study and sign the informed consent form；
• Female or male patients, aged ≥ 18 years, and ≤75 years;
• ECOG PS score: 0-1;
• Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH).
• Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery.
• Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM1.
• Could have been treated neoadjuvantly but have not reached pathologic complete response.

Критерии исключения

• metastatic disease (Stage IV) or inflammatory breast cancer
• Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
• Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
• A history of allergy to the drugs in this study；
• Unable or unwilling to swallow tablets
• History of gastrointestinal disease with diarrhea as the major symptom.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT05834764 · OBU-BC-II-083

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗