The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).

Официальное название

The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Early Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).

Обзор

This is a multi-center real-world study, in which patients who meet the inclusion criteria will receive treatment with Pyrotinib + Trastuzumab + Taxanes. Taxanes will be used for 6-8 cycles or discontinued due to intolerable Adverse Events (AEs), after which Capecitabine will be used for rhythmic chemotherapy combined with Pyrotinib + Trastuzumab. The aim is to explore the efficacy and safety of Pyrotinib, Trastuzumab, and Taxanes in treating Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).

Вмешательства

• Препарат Pyrotinib
  Pyrotinib 400mg qd po continuously
• Препарат Trastuzumab
  For Trastuzumab, the loading dose for the first treatment cycle is 8 mg/kg, and for subsequent cycles, 6 mg/kg. It is to be used once every three weeks
• Препарат Taxanes
  Taxanes: Usual clinical dose is administered, in a 21-day cycle.
• Препарат Capecitabine
  Capecitabine: 650mg/m2 each time, given twice daily

Первичные конечные точки

• PFS [Срок оценки: 24months]

Вторичные конечные точки (5)

• CNS-PFS [Срок оценки: 24months]
• ORR [Срок оценки: 24months]
• DCR [Срок оценки: 24months]
• OS [Срок оценки: 24months]
• Overall Number of Participants Who Experienced at Least One Adverse Event, Including Serious and Non-Serious Adverse Events [Срок оценки: 24months]

Критерии участия

Критерии включения

• Age: 18-70 years old, female;
• Pathological examination confirmed HER-2 positive invasive breast cancer; (HER2 positivity is defined as an immunohistochemical (IHC) score of 3+ or in-situ hybridization (ISH) result for HER2 gene amplification in >10% of immunoreactive cells.

HER2 positivity needs to be verified by the pathology department of the research center involved in this study)

• Imaging confirmed recurrent/metastatic breast cancer;
• Patients who relapsed and metastasized three months after discontinuation of Trastuzumab treatment;
• Have at least one measurable lesion (according to RECIST 1.1 criteria);
• ECOG score of 0-2;
• Expected life span ≥3 months;
• Normal major organ function;
• The researcher believes that the participant may benefit;
• Volunteer to participate in this study, sign informed consent.

Критерии исключения

Patients who meet any of the following criteria are not eligible for participation:

• Have any confirmed history of drug allergies, or severe allergic reactions to any component of the investigational drug (NCI-CTCAE 5.0 grade > 3);
• Patients in advanced stages who have undergone systemic treatment;
• A history of serious heart diseases such as congestive heart failure, unstable angina, arrhythmia or myocardial infarction;
• Suffer from serious pulmonary diseases, such as interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary diseases, etc.;
• Currently suffering from severe liver-related diseases, such as acute hepatitis, explosive hepatitis, coagulation factor synthesis disorder, etc.; Those who are positive for HBV surface antigen or HBV core antibody must have a peripheral blood Hepatitis B virus DNA titer test < 1×10 \^3 IU/ml in order to participate;
• Comorbidity or condition that may interfere with their participation in the study, or any serious medical impediment that might affect participant's safety (such as, active or uncontrolled infection, active liver/gallbladder disease requiring antiviral treatment);
• Other invasive tumors (including second primary breast cancer) that may affect the evaluation of results and adherence to the protocol;
• Having undergone major surgical procedure or are yet to recover from major internal diseases within the 4 weeks prior to the study;
• Any circumstance that the researcher considers the participant unfit to participate in the study.

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

• The Fourth Hospital of Hebei Medical University — Shijiazhuang

Идентификаторы

NCT: NCT06217185 · OBU-BC-II-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗