- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04900311
Pyrotinib Versus Pertuzumab in Combination With Neoadjuvant Trastuzumab and Nab-Paclitaxel in HER2+ Early or Locally Advanced Breast Cancer (Pyramid)
19 de maio de 2021 atualizado por: Tianjin Medical University Cancer Institute and Hospital
The study is being conducted to evaluate the efficacy, and safety of pyrotinib versus pertuzumab in combination with trastuzumab and nab-paclitaxel for neoadjuvant treatment in HER2+ early or locally advanced breast cancer patients.
To explore whether pyrotinib regimen could provide better clinical results compared with pertuzumab in the study population.
Visão geral do estudo
Status
Ainda não está recrutando
Descrição detalhada
This study is a multi-center, randomized, open-label, controlled trial.
Eligible patients will be randomized to neoadjuvant pyrotinib or pertuzumab containing regimen every 3 weeks for four cycles before surgery.
Randomization was stratified by the following factors: hormone receptor status and primary tumor size.
After completing four cycles of neoadjuvant treatment, all patients who are eligible for surgery will undergo surgery and have their pathologic response evaluated.
Following surgery, patients will receive 90-100 mg/m2 epirubicin and 600 mg/m2 cyclophosphamide every 3 weeks for 4 cycles.
Clinicians will select subsequent treatments for patients based on guidelines as well as clinical practice at each site.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
490
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Jin Zhang, MD, Professor
- Número de telefone: 2121 0086-22-23340123
- E-mail: zhangjin@tjmuch.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- female patients, treatment-naïve, aged ≥ 18 years and ≤ 75 years;
- ECOG score 0-1 (ECOG, Eastern Cooperative Oncology Group);
- Histologically confirmed invasive breast cancer (early stage or locally advanced) :Primary tumor greater than 2 cm diameter and cT2-cT4/cN0-cN3/cM0 (clinical stage II and III);
- HER2 expression positive breast cancer confirmed by pathological examination,
- known hormone receptor status (ER and PR);
- the level of major organ function must meet the following requirements: blood routine test: neutrophil (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (Hb) ≥ 90g/L; blood biochemistry test: total bilirubin (TBIL) ≤ 2.5 × ULN (upper normal limit); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; echocardiography: LVEF ((Left Ventricular Ejection Fraction) ≥ 55%; 12 ECG: QT interval corrected by Fridericia method (QTcF) < 470 ms in women
- Female subjects who have not yet experienced menopausal or not surgically sterile agree to practice abstinence or use effective methods of contraception for at least 7 months during and after the last dose of study drug;
- Sign the informed consent form and are willing to cooperate in the follow-up.
Exclusion Criteria:
- breast cancer of both sides, stage IV breast cancer or metastatic breast cancer;
- inflammatory breast cancer;
- History of other malignancy, or previous anti-cancer therapy or radiotherapy for any malignancy, excluding cured carcinoma in situ of the cervix or squamous or basal cell carcinoma.
- simultaneously participated in other clinical trials;
- Major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or from which the patient has not fully recovered
- blood transfusion, or received colony-stimulating factor treatments before randomization;
- known history of allergy to any of the study medications and any of the ingredients or excipients of these medications;
- history of immunodeficiency, including positive HIV test, or suffering from other acquired, congenital immunodeficiency diseases, or history of organ transplantation.
- had any heart disease, including: (1) angina pectoris; (2) arrhythmia that is clinically significant or required medication; (3) myocardial infarction; (4) heart failure; (5) any other heart disease judged by the investigator as not suitable for this trial.
- pregnant or lactating
- Other concurrent serious diseases that are serious hazards to the patient's safety or may interfere with planned treatment (including but not limited to hypertension, severe diabetes, active infection, thyroid disease, etc.) ;
- Inability to swallow, chronic diarrhea, bowel obstruction, and other factors affecting medication intake and absorption.
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for this study.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: pyrotinib + trastuzumab + nab-paclitaxel
|
patients will be treated every 3 weeks for four cycles prior to surgery at following doses: pyrotinib: 400 mg/day, orally, qd trastuzumab: IV infusion on Day 1 every 3 weeks with loading dose of 8 mg/kg in Cycle 1, and 6 mg/kg in Cycles 2-4 nab-paclitaxel: 260 mg/m2 IV infusion on Day 1 every 3 weeks, or 125 mg/m2 IV infusion on Days 1, 8 and 15 every 3 weeks (the nab-paclitaxel administration cycle was determined by investigator at each site)
|
Comparador Ativo: pertuzumab + trastuzumab + nab-paclitaxel
|
patients will be treated every 3 weeks for four cycles prior to surgery at following doses: pertuzumab: IV infusion on Day 1 every 3 weeks with loading dose of 840 mg for Cycle 1, followed by 420 mg for Cycles 2-4 trastuzumab: IV infusion on Day 1 every 3 weeks with loading dose of 8 mg/kg in Cycle 1, and 6 mg/kg in Cycles 2-4 nab-paclitaxel: 260 mg/m2 IV infusion on Day 1 every 3 weeks, or 125 mg/m2 IV infusion on Days 1, 8 and 15 every 3 weeks (the nab-paclitaxel administration cycle was determined by investigator at each site)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
tpCR (totally pathological Complete Response) assessed by the IRC(Independent Review Committee)
Prazo: Pathologic response will be evaluated right after surgery, which will be performed within 14 days after the completion neoadjuvant therapy (four cycles, 21 days per cycle).
|
defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant therapy and surgery.
|
Pathologic response will be evaluated right after surgery, which will be performed within 14 days after the completion neoadjuvant therapy (four cycles, 21 days per cycle).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
iDFS (Invasive disease-free survival)
Prazo: from the date of surgery till two years after study-defined treatment.
|
iDFS, defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of one of the following events:
|
from the date of surgery till two years after study-defined treatment.
|
EFS (event free survival)
Prazo: from the date of surgery till two years after study-defined treatment.
|
EFS, defined as time from randomization to the first documentation of one of the following events:
|
from the date of surgery till two years after study-defined treatment.
|
ORR (Objective Response Rate)
Prazo: At the end of neoadjuvant therapy (four cycles, 21 days per cycle).
|
the proportion of patients who achieved Complete Response (CR) or Partial Response (PR) during Cycles 1-4, according to RECIST v1.1
|
At the end of neoadjuvant therapy (four cycles, 21 days per cycle).
|
the rate of adopting breast-conserving surgery
Prazo: evaluated right after surgery, which will be performed within 14 days after the completion neoadjuvant therapy (four cycles, 21 days per cycle).
|
the proportion of patients who have undergone breast-conserving surgery
|
evaluated right after surgery, which will be performed within 14 days after the completion neoadjuvant therapy (four cycles, 21 days per cycle).
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Incidence of serious adverse events and other adverse events of special interest
Prazo: through study completion, an average of 2.5 years.
|
Assess the incidence of serious adverse events (SAEs) and other adverse events.
|
through study completion, an average of 2.5 years.
|
Exploratory biomarker analyses
Prazo: through study completion, an average of 2.5 years.
|
The correlation between baseline molecular biomarkers and efficacy outcomes will be evaluated.
Biomarkers may include blood lipids and metabolomics profiles based on Nuclear Magnetic Resonance techniques.
|
through study completion, an average of 2.5 years.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
1 de maio de 2021
Conclusão Primária (Antecipado)
1 de dezembro de 2023
Conclusão do estudo (Antecipado)
1 de dezembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
28 de abril de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de maio de 2021
Primeira postagem (Real)
25 de maio de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de maio de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de maio de 2021
Última verificação
1 de abril de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças de pele
- Neoplasias
- Neoplasias por local
- Doenças da mama
- Neoplasias da Mama
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antineoplásicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Agentes Antineoplásicos Fitogênicos
- Agentes Antineoplásicos Imunológicos
- Paclitaxel
- Trastuzumabe
- Paclitaxel ligado à albumina
- Pertuzumabe
Outros números de identificação do estudo
- MA-BC-II-020
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Sim
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em pyrotinib + trastuzumab + nab-paclitaxel
-
Fudan UniversityAtivo, não recrutandoTNBC - Câncer de Mama Triplo NegativoChina
-
William Sikov MDYale UniversityConcluídoCâncer de mamaEstados Unidos
-
Shengjing HospitalRecrutamento
-
Trishula Therapeutics, Inc.AbbVieRecrutamentoCâncer de pâncreasEstados Unidos
-
HutchmedAinda não está recrutando
-
Fundacion OncosurConcluído
-
M.D. Anderson Cancer CenterCelgene CorporationConcluídoMelanoma | Metástase HepáticaEstados Unidos
-
Changhai HospitalRecrutamento
-
Chinese PLA General HospitalRecrutamentoNeoplasias Pancreáticas | Câncer de pâncreas | Câncer de Pâncreas | PDAC - Adenocarcinoma Ductal PancreáticoChina
-
AIO-Studien-gGmbHCelgene; ClinAssess GmbHConcluídoCâncer de Pâncreas Ressecável | Adenocarcinoma Ductal do PâncreasAlemanha