An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO) (VIRGO)
8 de junho de 2017 atualizado por: Genentech, Inc.
An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer
This is a multicenter, prospective observational cohort study (OCS) designed to follow patients with locally recurrent or metastatic breast cancer in the United States. Two cohorts will be included:
- Patients with human epidermal growth factor receptor 2-negative (HER2-negative) disease receiving their first cytotoxic chemotherapy and/or targeted therapy (approximately 825 patients)
- Patients with hormone receptor-positive (HR-positive) disease receiving their first hormonal therapy for advanced disease (approximately 425 patients)
Patients who have received any chemotherapy for advanced disease more than 8 weeks prior to enrollment to this OCS will not be eligible. A total of approximately 1,250 patients will be enrolled. Approximately 150 study sites will be activated in order to achieve complete enrollment by December 2010.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
1287
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
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Breast cancer clinic
Descrição
Inclusion Criteria:
- Signed Informed Consent Form
- Locally recurrent or metastatic breast cancer
- Receipt of first systemic cytotoxic chemotherapy and/or targeted therapy among those with HER2-negative disease or first hormone therapy among those with HR-positive disease for the treatment of locally recurrent or metastatic disease, within 8 weeks prior to enrollment
Exclusion Criteria
- Any medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to provide informed consent or comply with the treatment
- Any prior chemotherapy started more than 8 weeks prior to enrollment for the treatment of locally recurrent or for metastatic breast cancer
- Concurrent participation only in a blinded clinical trial
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
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Chemotherapy Cohort
Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
|
Hormonal Therapy Cohort
Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression Free Survival
Prazo: Approximately 4.5 years
|
Progression free survival was defined as the time from enrollment to progression or death of any cause, whichever came first.
The disease response status was assessed by the investigator according to the method of his or her choice.
The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.
|
Approximately 4.5 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Survival
Prazo: Approximately 4.5 years
|
Overall survival was defined as the time from enrolment to death of any cause.
|
Approximately 4.5 years
|
|
Number of Participants With Tumor Response
Prazo: Approximately 4.5 years
|
The tumor response was measured as complete response, partial response, stable disease, progressive disease, or clinical deterioration based on their best overall response.
The tumor response was assessed by the investigator according to the method of his or her choice.
The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.
|
Approximately 4.5 years
|
|
Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation
Prazo: Approximately 4.5 years
|
Participants were assessed quarterly for progressive events and treatment status.
|
Approximately 4.5 years
|
|
Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death
Prazo: Approximately 4.5 years
|
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
An Serious Adverse Events (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
|
Approximately 4.5 years
|
|
Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy
Prazo: Approximately 4.5 years
|
All AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 as Grade 1 (mild), Graded 2 (moderate), Grade 3 (severe), Grade 4 (very severe, life threatening, or disabling), and Grade 5 (death related to AE).
Venous Thromboembolic Events (VTEs) included all Grade 4 or of more severity of deep vein thrombosis, pulmonary embolus; Arterial Thromboembolic Events (ATEs) Included new or worsening angina pectoris, myocardial infarction, stroke, transient ischemic attack, peripheral arterial ischemia of any NCI CTCAE grade; Left Ventricular Systolic Dysfunction (LVSD) included congestive heart failure) of NCI CTCAE Grade 2 or of more severity; Peripheral Neuropathy (PN) included sensory and/or motor events of Grade 3 or of more severity.
|
Approximately 4.5 years
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 (Real)
1 de junho de 2008
Conclusão Primária (Real)
1 de dezembro de 2012
Conclusão do estudo (Real)
1 de dezembro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
30 de julho de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de julho de 2008
Primeira postagem (Estimativa)
1 de agosto de 2008
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de julho de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de junho de 2017
Última verificação
1 de junho de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AVF4349n
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