- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00088972
S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women
Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing breast cancer.
PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing breast cancer in premenopausal women who are at risk for developing the disease.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
- Compare 1-year mammographic density in premenopausal women at high risk for developing breast cancer treated with celecoxib vs placebo.
- Compare 1-year proliferation of breast epithelial cells, as measured by Ki67 staining, in patients treated with these drugs.
- Compare the expression of other biomarkers, including cyclo-oxygenase-2 (COX-2) enzyme and a marker of apoptosis, in breast tissue of patients treated with these drugs.
- Compare 1-year plasma levels of insulin-like growth factor (IGF)-1, IGF binding protein-3, and prostaglandin E_2 in patients treated with these drugs.
- Compare the toxicity of these drugs in these patients.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to risk category (lobular carcinoma in situ or ductal carcinoma in situ vs BRCA1/2 mutation AND any Gail risk vs Gail risk ≥1.7% but < 5% vs Gail risk ≥ 5%) and prior tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Celocoxib: Patients receive oral celecoxib twice daily.
- Placebo: Patients receive oral placebo twice daily. In both arms, treatment continues for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
-
-
California
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Glendale, California, Estados Unidos, 91204
- Glendale Memorial Hospital Comprehensive Cancer Center
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-
New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87131-5636
- University of New Mexico Cancer Center
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Texas
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Houston, Texas, Estados Unidos, 77030
- Ben Taub General Hospital
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Houston, Texas, Estados Unidos, 77030
- Methodist Hospital
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Houston, Texas, Estados Unidos, 77030
- Veterans Affairs Medical Center - Houston
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Houston, Texas, Estados Unidos, 77030
- Baylor University Medical Center - Houston
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Houston, Texas, Estados Unidos, 77030
- St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
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Washington
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Seattle, Washington, Estados Unidos, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Seattle, Washington, Estados Unidos, 98195-6043
- University Cancer Center at University of Washington Medical Center
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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:
At elevated risk of developing breast cancer, as defined by 1 of the following:
- Modified Gail risk at 5 years ≥ 1.7% or lifetime risk ≥ 20% AND Claus Model, BRCAPro Model, or Tyrer-Cuzick Model lifetime risk ≥ 20%
- Diagnosis of lobular carcinoma in situ or ductal carcinoma in situ
- Known deleterious mutation of BRCA1 or BRCA2
- At least 1 breast available for imagery and biopsy
Has undergone a baseline mammogram with a standard density wedge within 7-14 days after completion of the last menstrual period AND within 7 days before study entry
- Mammogram normal or benign (BIRADS score 0 or 1)
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
Premenopausal, defined by 1 of the following criteria:
- Last menstrual period < 6 months ago AND no prior bilateral ovariectomy AND not on estrogen replacement therapy
- Prior hysterectomy (with ovaries still in place) AND normal follicle-stimulating hormone levels within 28 days of study entry
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin < 2.0 times institutional upper limit of normal (IULN)
- SGOT or SGPT < 2 times IULN
- Alkaline phosphatase < 2 times IULN
- INR ≤ 1.5
- PT and PTT ≤ IULN
Renal
- Serum creatinine < 2.0 times IULN
Cardiovascular
- No history of myocardial infarction
- No angina pectoris
- No known coronary artery disease
- No history of stroke or mini-stroke (e.g., transient ischemic attack)
- No history of thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism)
- No uncontrolled hypertension (i.e., blood pressure > 140/90 mmHg)
Pulmonary
- No asthma after taking aspirin or other NSAIDs
Other
- No known sensitivity to celecoxib
- No allergy to sulfonamides
- No urticaria or allergic-type reactions after taking aspirin or other NSAIDs
- No extreme lactose intolerance
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or early bladder cancer (preinvasive transitional cell carcinoma of the bladder)
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 5 years since prior biologic therapy for cancer
Chemotherapy
- More than 5 years since prior chemotherapy for cancer
Endocrine therapy
- At least 28 days since prior tamoxifen
- No prior systemic estrogen modifiers (SERMs) or aromatase inhibitors
- Concurrent hormonal contraception (i.e., pills, patches, or shots) allowed provided contraception was initiated prior to study entry
Radiotherapy
- No prior radiotherapy to the breast to be studied
Surgery
- Not specified
Other
- At least 7 days since prior anticoagulant therapy
More than 1 month since prior chronic daily aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) of more than 7 days duration
- Concurrent intermittent aspirin or NSAIDs allowed (no more than 10 days per month)
- No concurrent participation in another clinical trial for treatment or prevention of cancer unless no longer receiving treatment and is in the follow-up phase
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Arm I - Celecoxib
Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
|
Dado oralmente
|
Comparador de Placebo: Arm II - Placebo
Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
|
Dado oralmente
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Mammographic Density
Prazo: 1 year
|
The primary outcome measure is change in mammographic density.
The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.
|
1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Ki-67 Expression
Prazo: 1 year
|
The difference between the two arms in the percent of patients with non-zero ki-67 expression over the two time periods (baseline and 1-year).
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Powel H. Brown, MD, PhD, Baylor College of Medicine
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 (Real)
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
- Doenças de pele
- Neoplasias
- Neoplasias por local
- Doenças da mama
- Neoplasias da Mama
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes do Sistema Nervoso Periférico
- Inibidores Enzimáticos
- Analgésicos
- Agentes do Sistema Sensorial
- Agentes anti-inflamatórios não esteróides
- Analgésicos, Não Narcóticos
- Antiinflamatórios
- Agentes Antirreumáticos
- Inibidores da Ciclooxigenase
- Inibidores da Ciclooxigenase 2
- Celecoxibe
Outros números de identificação do estudo
- CDR0000377698
- U10CA012027 (Concessão/Contrato do NIH dos EUA)
- U10CA037429 (Concessão/Contrato do NIH dos EUA)
- S0300 (Outro identificador: SWOG)
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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