- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01325428
Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
17 de junho de 2016 atualizado por: Boehringer Ingelheim
An Open Label, Phase II Trial of Afatinib With or Without Vinorelbine for the Treatment of HER2-overexpressing Inflammatory Breast Cancer
The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer.
The study will include patients who have and have not failed prior trastuzumab treatment.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
26
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.
Locais de estudo
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Victoria
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East Bentleigh, Victoria, Austrália
- 1200.89.61002 Boehringer Ingelheim Investigational Site
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Western Australia
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Perth, Western Australia, Austrália
- 1200.89.61003 Boehringer Ingelheim Investigational Site
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California
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Los Angeles, California, Estados Unidos
- 1200.89.10001 Boehringer Ingelheim Investigational Site
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North Carolina
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Durham, North Carolina, Estados Unidos
- 1200.89.10005 Boehringer Ingelheim Investigational Site
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Hong Kong, Hong Kong
- 1200.89.85201 Boehringer Ingelheim Investigational Site
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Bournemouth, Reino Unido
- 1200.89.44002 Boehringer Ingelheim Investigational Site
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London, Reino Unido
- 1200.89.44001 Boehringer Ingelheim Investigational Site
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London, Reino Unido
- 1200.89.44003 Boehringer Ingelheim Investigational Site
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Seoul, Republica da Coréia
- 1200.89.82001 Boehringer Ingelheim Investigational Site
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Seoul, Republica da Coréia
- 1200.89.82002 Boehringer Ingelheim Investigational Site
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Bangkok, Tailândia
- 1200.89.66002 Boehringer Ingelheim Investigational Site
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Bangkok, Tailândia
- 1200.89.66004 Boehringer Ingelheim Investigational Site
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Chiangmai, Tailândia
- 1200.89.66003 Boehringer Ingelheim Investigational Site
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Hat-Yai, Songkhla, Tailândia
- 1200.89.66001 Boehringer Ingelheim Investigational Site
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Ariana, Tunísia
- 1200.89.21601 Boehringer Ingelheim Investigational Site
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Sousse, Tunísia
- 1200.89.21602 Boehringer Ingelheim Investigational Site
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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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion criteria:
- Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
- Locally advanced or metastatic disease
- Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)
- For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment
- Investigator-confirmed diagnosis of Inflammatory Breast Cancer
- Must have biopsiable disease
Exclusion criteria:
- Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population)
- Must not have received prior vinorelbine treatment
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: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Afatinib once daily (OD)
Patients receive afatinib monotherapy once daily until progression of their disease
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Patient to receive afatinib monotherapy until progression of their disease
Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Prazo: This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
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Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
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This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
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Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Prazo: This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
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Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
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This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Prazo: This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
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Objective response was defined on a patient level as a best response of CR or PR.
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This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
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Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Prazo: This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.
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Objective response was defined on a patient level as a best response of CR or PR.
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This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.
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Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Prazo: This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
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Objective response was defined on a patient level as a best response of CR or PR.
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This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
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Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).
Prazo: This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
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Objective response was defined on a patient level as a best response of CR or PR.
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This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
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Part A: Duration of Unconfirmed Objective Response.
Prazo: From first drug administration until end of Part A, up to 929 days.
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Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR).
Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)).
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From first drug administration until end of Part A, up to 929 days.
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Part B: Duration of Unconfirmed Objective Response.
Prazo: From first drug administration until end of Part B, up to 929 days.
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Objective response was defined on a patient level as a best response of CR or PR.
Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS).
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From first drug administration until end of Part B, up to 929 days.
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Part A: Progression Free Survival.
Prazo: From first drug administration until end of Part A, up to 713 days.
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PD was evaluated according to the RECIST version 1.1.
For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1.
The date of progression and date of first administration referred to the respective part of the study A.
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From first drug administration until end of Part A, up to 713 days.
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Part B: Progression Free Survival.
Prazo: From first drug administration until end of Part B, up to 230 days.
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PD was evaluated according to the RECIST version 1.1.
For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1.
The date of progression and date of first administration referred to the respective part of the study B.
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From first drug administration until end of Part B, up to 230 days.
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Progression Free Survival Over the Whole Sudy.
Prazo: From first drug administration until end of study, up to 700 days.
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PD was evaluated according to the RECIST version 1.1.
Number of days from the start of monotherapy to the date of second PD.
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From first drug administration until end of study, up to 700 days.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
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
1 de agosto de 2011
Conclusão Primária (Real)
1 de novembro de 2014
Conclusão do estudo (Real)
1 de novembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
28 de março de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de março de 2011
Primeira postagem (Estimativa)
29 de março de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
19 de julho de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de junho de 2016
Última verificação
1 de junho de 2016
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças de pele
- Neoplasias
- Neoplasias por local
- Doenças da mama
- Neoplasias da Mama
- Neoplasias Inflamatórias da Mama
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Agentes Antineoplásicos Fitogênicos
- Inibidores de proteína quinase
- Vinorelbina
- Afatinibe
Outros números de identificação do estudo
- 1200.89
- 2010-024454-10 (Número EudraCT: EudraCT)
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 Afatinib once daily (OD)
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GlaxoSmithKlineConcluído