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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00369850
Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98
Investigating Bone Density and Bone Loss Without Baseline Information
RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better treatment.
PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women with breast cancer receiving treatment in clinical trial IBCSG-1-98.
Visão geral do estudo
Status
Condições
Descrição detalhada
OBJECTIVES:
- Compare the effects on bone mineral density (BMD) in the L2-L4 (posterio-anterior) region of the spine and hip by assessing bone density in postmenopausal women with breast cancer receiving treatment on protocol IBCSG-1-98.
- Compare the incidence of radiological gross changes and fractures identified from spine x-rays (T4-L4) in these patients (in groups 1 and 2).
- Use longitudinal BMD measurements to estimate a linear rate of bone loss based on mixed effect models.
- Identify serum markers for bone loss to determine how they correlate with osteoporosis, microfractures, clinical fractures, and breast cancer-related bone events.
OUTLINE: This is a multicenter study and a substudy of protocol IBCSG-1-98. Patients are assigned to 1 of 3 groups according to the length of treatment they have undergone on protocol IBCSG-1-98.
- Group 1 (prior to or at the end of the second year of treatment on protocol IBCSG-1-98): Patients undergo bone mineral density (BMD) testing of the L2-L4 spine and hip at baseline and years 1, 2, 3, and 4 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 1, 3, and 4 from baseline.
- Group 2 (after 2 years but before the end of the third year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1, 2, and 3 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 2 and 3 from baseline.
- Group 3 (after 3 years but before the end of the fifth year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1 and 2 from baseline (for patients in 4th year of treatment) or year 1 from baseline (for patients in 5th year of treatment).
Patients undergo blood collection at baseline and periodically during study for biomarker correlative study.
PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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New South Wales
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Randwick, New South Wales, Austrália, 2031
- Institute of Oncology at Prince of Wales Hospital
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Queensland
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Brisbane, Queensland, Austrália, 4029
- Royal Brisbane and Women's Hospital
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Madrid, Espanha, 28034
- Hospital Ruber Internacional
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Bordeaux, França, 33076
- Institut Bergonie
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Aviano, Itália, 33081
- Centro di Riferimento Oncologico - Aviano
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Bergamo, Itália, 24100
- Ospedali Riuniti di Bergamo
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Milano, Itália, 20141
- European Institute of Oncology
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Dunedin, Nova Zelândia
- Dunedin Hospital
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Lima, Peru, 34
- Instituto Nacional de Enfermedades Neoplasicas
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Aarau, Suíça, CH-5001
- Kantonspital Aarau
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Bern, Suíça, CH-3010
- Inselspital Bern
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Lausanne, Suíça, CH-1011
- Centre Hospitalier Universitaire Vaudois
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Mendrisio, Suíça, CH-6850
- Ospedale Beata Vergine
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St. Gallen, Suíça, CH-9007
- Kantonsspital - St. Gallen
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Thun, Suíça, 3600
- Regionalspital
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Cape Town, África do Sul, 7925
- Groote Schuur Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
- Resected disease
Enrolled on protocol IBCSG-1-98
Receiving adjuvant endocrine therapy comprising 1 of the following regimens:
- Letrozole
- Tamoxifen
- Letrozole after 2 years of tamoxifen
- Tamoxifen after 2 years of letrozole
- Not yet completed 5 years of treatment
- No breast cancer recurrence or second primary cancer
- No known, symptomatic bone disease, including osteomalacia or osteogenesis imperfecta
- No prior registration to protocol IBCSG-1-98 Bone Mineral Density substudy
Hormone receptor status:
- Estrogen receptor-positive and/or progesterone receptor-positive tumor
PATIENT CHARACTERISTICS:
- Female
- Postmenopausal
- No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary diseases
- No malabsorption syndrome or clinically relevant vitamin D deficiency
- No patients for whom the bone density determination is impossible
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 1 year since prior and no concurrent anticonvulsants
- More than 6 weeks since prior and no concurrent corticosteroids (at doses > the equivalent of 5 mg/day prednisone) for > 2 weeks total
- No prior or concurrent sodium fluoride (at daily doses ≥ 5 mg/day) for > 1 month
- More than 12 months since prior and no concurrent anabolic steroids
- More than 6 months since prior treatment, either investigational or not, for the prevention of osteoporosis (excluding calcium or cholecalciferol [vitamin D])
- No concurrent raloxifene
- Concurrent therapeutic intervention for osteoporosis comprising bisphosphonates allowed
- Concurrent warfarin allowed provided it is given for ≤ 4 weeks
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Tamoxifeno 2 anos mais letrozol 3 anos
Pacientes tratados com tamoxifeno por 2 anos e posteriormente com letrozol por 3 anos.
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Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
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Experimental: Tamoxifen for 5 years
Patients treated with tamoxifen for 5 years after randomisation.
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Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
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Experimental: Letrozole for 5 years
Patients treated with letrozole for 5 years after randomisation.
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Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
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Experimental: Letrozole 2 years plus tamoxifen 3 years
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
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Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Relative percent change of bone mineral density (BMD) form baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98
Prazo: 5 years after randomisation to BIG 1-98
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5 years after randomisation to BIG 1-98
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Recovery of BMD at 1 year after the completion of treatment on protocol IBCSG-1-98
Prazo: 6 years after randomisation to BIG 1-98
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6 years after randomisation to BIG 1-98
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Proportion of patients with BMD below the absolute threshold value for osteoporosis
Prazo: 5 years after randomisation to BIG 1-98
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5 years after randomisation to BIG 1-98
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Relative percent change in markers of bone resorption from baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98
Prazo: 5 years after randomisation to BIG 1-98
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5 years after randomisation to BIG 1-98
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Recovery of the markers of bone resorption at 1 year after the completion of treatment on protocol IBCSG-1-98
Prazo: 6 years after randomisation to BIG 1-98
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6 years after randomisation to BIG 1-98
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Stefan Aebi, MD, University Hospital Inselspital, Berne
- Cadeira de estudo: Andrea Decensi, MD, European Institute of Oncology
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CDR0000482381
- NOVARTIS-2026703019 (Outro identificador: Novartis)
- IBCSG-18-98-BS (Outro identificador: IBCSG)
- EU-20623 (Outro identificador: EU)
- IBCSG-1-98-BS (Outro identificador: IBCSG)
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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