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A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer

19 de dezembro de 2012 atualizado por: Hoffmann-La Roche

A Randomized, Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer

This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

2611

Estágio

  • Fase 3

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

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 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  • female patients 18-70 years of age;
  • adenocarcinoma of the breast;
  • previous invasive breast cancer if diagnosed >5 years before entering study;
  • no evidence of metastatic disease.

Exclusion Criteria:

  • history of severe hypersensitivity reaction to Taxotere;
  • previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;
  • treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.

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: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 1
Medicamento: capecitabina [Xeloda]
825 mg/m2 por via oral nos dias 1-14 de cada ciclo de 3 semanas
Medicamento: Taxotere
75mg/m2 iv no dia 1 de cada ciclo de 3 semanas
Medicamento: Taxotere
100mg/m2 iv on day 1 of each 3 week cycle
Comparador Ativo: 2
Medicamento: Taxotere
75mg/m2 iv no dia 1 de cada ciclo de 3 semanas
Medicamento: Taxotere
100mg/m2 iv on day 1 of each 3 week cycle

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Disease Free Survival [Number of Events]
Prazo: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Number of patients with/without recurrence of breast cancer, or death due to any cause.
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival [Time to Event]
Prazo: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Survival [Number of Events]
Prazo: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Number of patients who died/were alive.
Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Overall Survival [Time to Event]
Prazo: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive.
Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Breast Cancer Free Survival [Number of Events]
Prazo: Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .
Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer.
Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .
Breast Cancer Free Survival [Time to Event]
Prazo: Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]
Prazo: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event
Prazo: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including Any New Cancer as Event [Number of Events]
Prazo: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including Any New Cancer as Event [Time to Event]
Prazo: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hoffmann-La Roche

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.

Publicações Gerais

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 2002

Conclusão Primária (Real)

1 de junho de 2010

Conclusão do estudo (Real)

1 de maio de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

5 de agosto de 2004

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de agosto de 2004

Primeira postagem (Estimativa)

6 de agosto de 2004

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

21 de dezembro de 2012

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de dezembro de 2012

Última verificação

1 de dezembro de 2012

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NO17629

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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 .

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