- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00281697
A Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With Chemotherapy in Previously Treated Metastatic Breast Cancer (RIBBON 2)
5 de julho de 2013 atualizado por: Genentech, Inc.
A Phase III, Multicenter, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Treated Metastatic Breast Cancer
This phase III, multicenter, randomized, placebo-controlled, blinded trial is designed to evaluate the efficacy and safety of bevacizumab when combined with standard chemotherapy compared with chemotherapy alone in subjects with previously treated metastatic breast cancer.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
For all Outcome Measures except Overall Survival and One-year Survival, the Time Frame was from Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years 2 months).
For the Outcome Measures Overall Survival and One-year Survival, the Time Frame was from Baseline to the end of the study (up to 6 years, 7 months).
Tipo de estudo
Intervencional
Inscrição (Real)
684
Estágio
- Fase 3
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
Tudo
Descrição
Inclusion Criteria:
- Signed informed consent form.
- ≥ 18 years of age.
- Histologically confirmed carcinoma of the breast with measurable or non-measurable metastatic disease that has progressed (patients with a history of brain metastasis are eligible for study participation [USA only], as long as their brain metastases have been treated and they have no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone).
- Progression of disease during or following administration of one (non-investigational) chemotherapy regimen administered in the first-line setting.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- For women of childbearing potential, use of an effective means of non-hormonal contraception.
- Life expectancy ≥ 3 months.
- Willingness and capacity to comply with study and follow-up procedures.
Exclusion Criteria:
- Prior hormonal therapy only as treatment for metastatic disease without chemotherapy. Patients must have received chemotherapy for their metastatic disease in the first-line setting. Hormone therapy alone is not allowed.
- For subjects who have received prior anthracycline-based therapy, documentation of left ventricular ejection fraction < 50% by either multiple gated acquisition (MUGA) or echocardiogram (ECHO).
- Treatment with more than one prior cytotoxic regimen for metastatic breast cancer (MBC).
- HER2-positive status (patients who have unknown HER2 status, and for whom determination of HER2 status is not possible, are eligible for this study).
- Unknown estrogen receptor (ER) and progesterone receptor (PR) status.
- Radiation therapy other than for palliation or brain metastasis, biologic therapy, or chemotherapy for MBC within 21 days prior to Day 0 (Day 1 of Cycle 1 of treatment).
- Prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) pathway-targeted therapy.
- Untreated brain metastasis.
- Inadequately controlled hypertension.
- Unstable angina.
- New York Heart Association Grade II or greater congestive heart failure (CHF).
- History of myocardial infarction within 6 months prior to Day 0 (the day of the first bevacizumab/placebo infusion).
- History of stroke or transient ischemic attack within 6 months prior to Day 0.
- Clinically significant peripheral vascular disease.
- Evidence of bleeding diathesis or coagulopathy.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major elective surgical procedure during the study.
- Minor surgical procedures, fine-needle aspirations, or core biopsies within 7 days prior to Day 0.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0.
- Serious, non-healing wound, ulcer, or bone fracture.
- History of anaphylactic reaction to monoclonal antibody therapy not controlled with treatment premedication.
- History of other malignancies within 5 years of Day 0, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- inadequate organ function.
- Pregnancy (positive serum pregnancy test) or lactation.
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the subject at high risk from treatment complications.
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: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Standard chemotherapy + bevacizumab
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
|
The dose of bevacizumab was based on a patient's weight at baseline and remained the same throughout the study.
Outros nomes:
Patients received one of the following four standard chemotherapies for metastatic breast cancer.
|
Comparador de Placebo: Standard chemotherapy + placebo
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
|
Patients received one of the following four standard chemotherapies for metastatic breast cancer.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Progression-free Survival
Prazo: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)
|
PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first.
For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions.
For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically.
All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.
|
Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)
Prazo: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)
|
Progression-free survival was defined as the time from randomization to first documented disease progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first.
Results are reported for each of the 4 standard chemotherapy cohorts used in the study.
|
Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)
|
Overall Survival
Prazo: Baseline to the end of the study (up to 6 years, 7 months)
|
Overall survival was defined as the time from randomization to death from any cause.
|
Baseline to the end of the study (up to 6 years, 7 months)
|
One-year Survival
Prazo: Baseline to the end of the study (up to 6 years, 7 months)
|
Percentage of patients who survived 1 year in the study.
|
Baseline to the end of the study (up to 6 years, 7 months)
|
Objective Response
Prazo: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)
|
A patient had an objective response if they had a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST.
For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.
|
Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)
|
Duration of Objective Response
Prazo: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)
|
Duration of objective response was defined as the time from the initial response to documented disease progression or death from any cause, whichever occurred first.
Duration of objective response was only analyzed in patients who achieved an objective response.
|
Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Leo Faoro, MD, Genentech, Inc.
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 fevereiro de 2006
Conclusão Primária (Real)
1 de março de 2009
Conclusão do estudo (Real)
1 de setembro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
23 de janeiro de 2006
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de janeiro de 2006
Primeira postagem (Estimativa)
25 de janeiro de 2006
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
26 de julho de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de julho de 2013
Última verificação
1 de julho de 2013
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
- Efeitos Fisiológicos das Drogas
- Agentes Antineoplásicos
- Agentes Antineoplásicos Imunológicos
- Inibidores de angiogênese
- Agentes Moduladores da Angiogênese
- Substâncias de crescimento
- Inibidores de crescimento
- Bevacizumabe
Outros números de identificação do estudo
- AVF3693g
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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