Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer
10 de julio de 2026 actualizado por: Shu Wang, Peking University People's Hospital
Real-world Study of Pyrotinib-containing Regimens in First-line or Second-line Treatment of Advanced HER2-positive Breast Cancer
Given that pyrotinib has been proven to exert significant efficacy against HER2-positive advanced breast cancer in multiple Phase III studies, and the novel ADC drug disitamab vedotin has demonstrated potent anti-tumor activity, there remains insufficient real-world data on their sequential administration.
This multicenter, prospective real-world study plans to enroll 500 patients with HER2-positive advanced breast cancer receiving first-line or second-line treatment.
It aims to evaluate the efficacy and safety of sequential disitamab vedotin treatment after disease progression or intolerance to pyrotinib-based regimens (first-line: pyrotinib plus trastuzumab combined with chemotherapy; second-line: pyrotinib plus capecitabine).
The primary endpoint is real-world second progression-free survival (rwPFS2), while secondary endpoints cover real-world progression-free survival (rwPFS), tumor response, overall survival (OS), time to treatment failure, safety profiles and patient-reported outcomes.
It is currently expected to further validate the efficacy and safety of pyrotinib in patients with advanced HER2-positive breast cancer in the real-world setting, and to evaluate the efficacy and safety of recindopril trastuzumab following pyrotinib-containing regimens.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
500
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: peng yuan
- Número de teléfono: 86+13671287670
- Correo electrónico: 13671287670@163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100044
- Reclutamiento
- Peking University People's Hospital
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Contacto:
- yuan peng
- Número de teléfono: 86+13671287670
- Correo electrónico: 13671287670@163.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Aged ≥ 18 years old;
- Histopathologically confirmed HER2-positive inoperable locally advanced or metastatic breast cancer;
Patients with first-line or second-line advanced disease:
First-line advanced disease: no prior systemic therapy for locally advanced or metastatic disease. For patients who received neoadjuvant or adjuvant therapy, the disease-free interval (DFI) after the completion of the last chemotherapy or HER2-targeted therapy was more than 12 months; Second-line advanced disease: prior treatment with taxane combined with trastuzumab, with or without pertuzumab, in the advanced setting; or recurrence occurring during neoadjuvant/adjuvant therapy, or a disease-free interval (DFI) of ≤ 12 months after completion of the last neoadjuvant/adjuvant chemotherapy and HER2-targeted therapy;
- Planned to receive pyrotinib-containing regimen, and judged by investigators based on clinical practice to have potential subsequent treatment with Ruikang trastuzumab after failure of pyrotinib-containing therapy;
- Traceable medical records available throughout the treatment period.
Exclusion Criteria:
- Failure to sign the informed consent form;
- Pregnant or lactating females;
- Patients participating in any interventional clinical trial involving investigational drugs or marketed drugs at enrollment;
- Other conditions deemed ineligible for enrollment by the investigator's judgment.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Cohort A
This cohort consists of patients with first-line advanced disease.
First-line advanced disease is defined as no prior systemic therapy administered for locally advanced or metastatic disease.
For patients who have received neoadjuvant or adjuvant therapy, the disease-free interval (DFI) after the completion of the last chemotherapy or HER2-targeted therapy must be longer than 12 months.
First-line patients receive treatment with pyrotinib plus trastuzumab combined with chemotherapy.
Upon disease progression or intolerance to pyrotinib-containing regimens, subsequent treatment with Trastuzumab Rezetecan will be administered.
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Pyrotinib: administered orally once daily at a dose of 400 mg, 320 mg or 240 mg within 30 minutes after breakfast.
A continuous administration of 21 days is defined as one treatment cycle.
The dosage of pyrotinib will be adjusted by physicians according to the individual clinical conditions.
Concomitant chemotherapeutic agents and other supportive care treatments are determined at the investigators' discretion in accordance with clinical practice guidelines and drug instructions.
Trastuzumab Rezetecan: administered intravenously at a dose of 4.8 mg/kg on Day 1 of each cycle, with a 21-day treatment cycle.
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Experimental: Cohort B
This cohort includes patients with second-line advanced breast cancer.
Second-line advanced disease is defined as prior receipt of taxane combined with trastuzumab, with or without pertuzumab, in the advanced setting; or disease recurrence during neoadjuvant/adjuvant therapy, or a disease-free interval (DFI) of ≤ 12 months after completion of the last cycle of neoadjuvant/adjuvant chemotherapy and HER2-targeted therapy.
Patients in the second-line setting are treated with pyrotinib plus capecitabine.
Following disease progression or intolerance to pyrotinib-containing regimens, subsequent treatment with Trastuzumab Rezetecan is administered.
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Pyrotinib: administered orally once daily at a dose of 400 mg, 320 mg or 240 mg within 30 minutes after breakfast.
A continuous administration of 21 days is defined as one treatment cycle.
The dosage of pyrotinib will be adjusted by physicians according to the individual clinical conditions.
Concomitant chemotherapeutic agents and other supportive care treatments are determined at the investigators' discretion in accordance with clinical practice guidelines and drug instructions.
Trastuzumab Rezetecan: administered intravenously at a dose of 4.8 mg/kg on Day 1 of each cycle, with a 21-day treatment cycle.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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rwPFS2
Periodo de tiempo: From the start of first administration of pyrotinib-containing regimen (first-line or second-line) until disease progression or death occurring after the initiation of subsequent trastuzumab Rezetecan therapy，assessed up to 60 months.
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Second assessment of real-world progression-free survival (rwPFS2): defined as the time (in months) from the initial administration of pyrotinib-containing regimens (first-line pyrotinib combined with trastuzumab plus chemotherapy, or second-line pyrotinib combined with capecitabine) to disease progression or death after the initiation of subsequent Trastuzumab Rezetecan therapy.
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From the start of first administration of pyrotinib-containing regimen (first-line or second-line) until disease progression or death occurring after the initiation of subsequent trastuzumab Rezetecan therapy，assessed up to 60 months.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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rwPFS
Periodo de tiempo: From the start of initial pyrotinib treatment until the occurrence of disease progression, death, or switch to trastuzumab rezetecan due to intolerable toxicity，assessed up to 60 months.
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Real-world progression-free survival (rwPFS): defined as the time from the initial initiation of pyrotinib treatment to disease progression, death, or switch to Trastuzumab Rezetecan due to intolerable toxicity.
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From the start of initial pyrotinib treatment until the occurrence of disease progression, death, or switch to trastuzumab rezetecan due to intolerable toxicity，assessed up to 60 months.
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OS
Periodo de tiempo: From the initiation of the study treatment regimen to death from any cause，assessed up to 60 months.
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Overall Survival (OS): defined as the time from the initiation of the study treatment regimen to death from any cause.
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From the initiation of the study treatment regimen to death from any cause，assessed up to 60 months.
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rwORR
Periodo de tiempo: From the initiation of the study treatment regimen until disease progression or study withdrawal，assessed up to 60 months.
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Real-world Objective Response Rate (rwORR): refers to the percentage of subjects with a best overall response of CR or PR from the initiation of the study treatment regimen until disease progression and study withdrawal, among the total number of subjects in the analysis set.
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From the initiation of the study treatment regimen until disease progression or study withdrawal，assessed up to 60 months.
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rwTTF
Periodo de tiempo: From the initiation of the study treatment regimen until disease progression or study withdrawal，assessed up to 60 months.
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Real-world Time to Treatment Failure (rwTTF): defined as the time from the date of treatment initiation to treatment discontinuation for any reason, including but not limited to disease progression, death, adverse drug reactions/toxicity, patient preference, and initiation of subsequent-line therapy.
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From the initiation of the study treatment regimen until disease progression or study withdrawal，assessed up to 60 months.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: wang shu, Peking University People's Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
6 de julio de 2026
Finalización primaria (Estimado)
30 de diciembre de 2031
Finalización del estudio (Estimado)
30 de diciembre de 2031
Fechas de registro del estudio
Enviado por primera vez
7 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de mayo de 2026
Publicado por primera vez (Actual)
20 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de julio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MA-BC-RWS-141
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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