- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00131963
A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin (A)/Cyclophosphamide ©) and/or Weekly Paclitaxel
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well doxorubicin, cyclophosphamide, and/or paclitaxel work in treating women with nonmetastatic breast cancer.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
Primary
- Determine the pharmacogenomics of adjuvant chemotherapy comprising doxorubicin and cyclophosphamide and/or paclitaxel in women with nonmetastatic invasive breast cancer.
- Determine treatment-induced myelosuppression (e.g., neutropenia) in patients treated with adjuvant doxorubicin and cyclophosphamide who have polymorphisms in drug activation and metabolism genes.
- Correlate the incidence of peripheral neuropathy with pharmacogenomic analysis in patients treated with paclitaxel.
Secondary
- Determine response (i.e., relapse in the adjuvant setting) during a 10-year follow-up period in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients receive treatment on The Cancer and Leukemia Group B study(CALGB) CALGB-40101 OR are assigned to receive 1 of 2 treatment regimens on this study.
- Regimen 1: Patients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
- Regimen 2: Patients receive doxorubicin and cyclophosphamide as in regimen 1. Patients then receive paclitaxel IV over 1 hour once weekly for 12 weeks.
After completion of study treatment, patients are followed at 3, 6, and 12 months and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 500 patients (300 treated with doxorubicin and cyclophosphamide and 200 treated with paclitaxel) will be accrued for this study within 3-4 years.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke Cancer Institute
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Eligibility Criteria
- Histologically confirmed invasive breast cancer
- node negative stage > T1c or T1b with poor prognostic features (high grade, Her2/neu FISH positive, ER negative) or stage 2 (T2, N0) or
- enrolled on CALGB 40101, CALGB 49909, or the National Cancer Institute of Canada study MA-21 or
- any node positive patient or locally advanced undergoing neoadjuvant chemotherapy with either AC or paclitaxel
- Age greater than or equal to 18 years.
- >/=2 weeks from major surgery (wide excision / lumpectomy / mastectomy)
- No evidence of systemic metastasis
- Undergoing adjuvant treatment with standard dose AC or AC followed by weekly Paclitaxel at 80mg/m2
- Adequate bone marrow, hepatic and renal functions (absolute neutrophil count >1,500/ μl, platelet count > 100,000/ μl, serum creatinine <2.0 mg/dl, total Bilirubin <2.0 x the upper limit of normal (ULN)
- Ability to answer and understand study surveillance questionnaires
- No concurrent drug therapy (within 2 weeks) with agents that are known inducers or inhibitors of Cytochrome P450 (CYP450).
Exclusion Criteria
- Other anticancer cytotoxic or endocrine therapy, immunotherapy, or biologic response modifiers,Study Drugs or other concomitant medications known to cause myelosuppression especially neutropenia and neuropathy
- Eastern Cooperative Oncology Group Performance Status(ECOG) functional status > 2.
- Serious co-morbidities including poorly controlled diabetes mellitus, ischaemic heart disease,uncontrolled hypertension or active infection.
- Pregnancy
- Use of growth factor during cycle 1 of chemotherapy (AC) under pharmacokinetic evaluation
- Grade >/=2 peripheral neuropathy symptoms based on National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) Scale. Exception: a chronic neurologic disorder will be reviewed on a case by case basis by the study PI.
Prior treatment with weekly paclitaxelDISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:
Node negative disease AND meets 1 of the following stage criteria:
- Primary tumor > T1c
Primary tumor > T1b AND poor prognostic features, defined as the following:
- High-grade disease
- Human Epidermal Growth Factor Receptor 2 (HER2)/neu-positive disease by fluorescence in situ hybridization
- Estrogen receptor-negative disease
- Stage II disease (T2, N0)
- Node positive nonmetastatic disease
- Locally advanced disease AND receiving neoadjuvant chemotherapy comprising doxorubicin and cyclophosphamide OR paclitaxel
- Enrolled in clinical trial CALGB-40101
- No evidence of systemic metastasis
Hormone receptor status:
- Not specified
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
Regimen 1
Patients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over 30 minutes on day 1.
Treatment repeats every 21 days for 4 courses.
|
Dado IV
Outros nomes:
Dado IV
Outros nomes:
|
Regimen 2
Patients receive doxorubicin and cyclophosphamide as in regimen 1. Patients then receive paclitaxel IV over 1 hour once weekly for 12 weeks.
|
Dado IV
Outros nomes:
Dado IV
Outros nomes:
Dado IV
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Treatment-induced myelosuppression (e.g., neutropenia)
Prazo: 12 months
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12 months
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Incidence of peripheral neuropathy
Prazo: 12 month
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12 month
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Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Response (relapse in adjuvant setting) for 10 years after completion of study treatment
Prazo: Ten years
|
Ten years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Paul K. Marcom, MD, Duke Cancer Institute
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
- Doenças de pele
- Neoplasias
- Neoplasias por local
- Doenças da mama
- Neoplasias da Mama
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antirreumáticos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Agentes Antineoplásicos Alquilantes
- Agentes Alquilantes
- Agonistas Mieloablativos
- Agentes Antineoplásicos Fitogênicos
- Inibidores da Topoisomerase II
- Inibidores da Topoisomerase
- Antibióticos, Antineoplásicos
- Ciclofosfamida
- Paclitaxel
- Doxorrubicina
Outros números de identificação do estudo
- Pro00014267
- DUMC-4522-04-1-R1 (Outro identificador: Duke IRB)
- CDR0000438673 (Outro identificador: National Cancer Institute)
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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