- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01836640
Developing Plasma DNA as a Surrogate for Tumor Biopsy to Identify Tumor Genetic Alterations in Patients With Advanced Breast Cancer
There are three major subtypes of breast cancer:
- Hormone receptor positive (contain cells that express the estrogen receptor or progesterone receptor).
- Tumors that express the epidermal growth factor receptor gene ( HER-2)
- Triple negative (cancer cells that lack the hormone receptors and the epidermal growth factor receptor gene HER-2.
While effective therapies exist for most cases of breast cancer at first occurrence, many patients eventually exhibit disease that does not respond to all standard breast therapies, particularly in the metastatic setting.
There are therapies that are used to treat other types of cancers with genetic mutations that are in the process of being evaluated for use in breast cancer. The current techniques used for detecting mutations in the genes of breast cancer patients, which can be treated with drugs specific for the genetic mutations, are invasive and identifying effective diagnostic non-invasive procedures are the next challenge for physicians. This study will compare the ability to detect genetic mutations samples from non-invasive procedures such as a blood draw, to more invasive procedures such as tissue taken from a biopsy sample.
There is also a concern with current techniques used to detect genetic mutations that cells from a single tissue sample may not be representative of the types of cells present in all the tumors in the body and therapies selected using a single tissue sample may not be effective for all of the cancer in the body. This study will use blood drawn from participants prior to any drug therapy and compare the genes from this blood to tissue samples from multiple sites of disease.
The study will also compare the genetic profile of the metastatic tumors to the genetic profile of the original breast cancer to determine if there are any changes in the genetics of the tumor cells.
The participants that have newly diagnosed metastatic disease will provide tissue from their primary site of disease via an image guided biopsy. These participants will also provide tissue from at least 2 other distant metastatic sites (lung, pleural/peritoneal, liver, brain, or skin). Each biopsy procedure will attempt to obtain 2-3 samples for research purposes.
Participants that have locally recurrent disease in the breast will have the tissue from the site of re-occurrence biopsied as well as two distant metastatic sites (lung, pleural/peritoneal, liver, brain, or skin). Participants that have either multi-centric disease or bilateral disease will have all tumors sampled with the intention of providing 2-3 samples/tumor for research purposes. Participants with multi-centric and bilateral disease will also have 2 distant sites of distant disease sampled (lung, pleural/peritoneal, liver, brain, or skin).
Prior to any scheduled biopsy procedures all participants will have a blood draw used to examine the genetics of the tumor cells in the blood. The participants will have 8 tubes of blood drawn for the test and then they will proceed onto the tissue sampling portion of the study.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth-Hitchcock Medical Center
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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
Inclusion Criteria:
- 3.1 Radiographic evidence of new or progressive metastatic breast cancer by CT chest/abdomen/pelvis and bone scan, or by PET scan.
- 3.2 Patient must have ≥3 sites of disease involving ≥2 organ sites appropriate for biopsy. Treating physician, in consultation with interventional radiologist as needed, will select sites for potential biopsy (see section 5.2.2 for guidance on evaluable sites.)Histologic documentation of metastatic invasive breast cancer with metastasis to a distant organ site (lung, liver, pleural/peritoneal, skin [if skin, must be determined by treating physician that it is not skin involvement from breast primary or local regional recurrence], and/or bone) by core needle or excisional biopsy.
- 3.3 The subject must agree to undergo and be able to tolerate the research biopsy(ies) and blood draw.
- 3.4 Prior chemotherapy, endocrine therapy, or radiotherapy with therapeutic intent is allowed in the metastatic setting. However, for patients currently receiving such treatment(s), archived tumor specimens will not count towards the required biopsy of 3 tumors
- 3.5 Women or men > age 18.
- 3.6 Ability to give informed consent.
- 3.7 Normal Prothrombin Time/International Normalized Ratio within 30 days of any diagnostic biopsies, or if patient is on anticoagulation therapy, approval is required by provider doing the biopsy.
- 3.8 Negative pregnancy test or beyond reproductive potential.
- 3.9 Medical evaluation by medical oncology within 4 weeks.
- 3.10 Previous but not current smokers are eligible if they have not smoked for more than 10 years and have less than 25 pk yr smoking history, see exclusion criterion 3.14.
Exclusion Criteria:
3.12 Poor venous access (unable to tolerate large-gauge needle).
3.13 Unable to tolerate blood draw or research biopsy procedures.
3.14 Current smokers or smoked at all within the last 10 years, or have a lifetime smoking history greater than 25 pack-years. (One pack year is equal to smoking 1 pack per day for 1 year; 5 pack years = one pack/day for 5 yrs, or ½ pack/day for 10 yrs, etc.). There is evidence that smoking increases the likelihood of detecting mutations in cancer-related genes in plasma DNA in healthy individuals (i.e., who do not have detectable cancer) (15, 16). We wish to avoid detecting such genetic lesions in this pilot study by excluding current, recent and heavy smokers
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Genetic Lesion detection
Prazo: baseline
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To determine whether the genetic mutations in plasma DNA are reflective of the genetic mutations present in biopsies of tumor tissue obtained from ≥ 3 tumors within patients with metastatic breast cancer.
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baseline
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Somatic genetic mutations in tumor samples
Prazo: baseline
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To determine the amount of plasma DNA required to capture all somatic genetic mutations as represented in biopsied tumor samples.
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baseline
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Genetic heterogeneity among metastatic tumors.
Prazo: baseline
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To determine the extent of genetic heterogeneity among biopsies of different metastatic tumors within patients with metastatic breast cancer.
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baseline
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Genetic heterogeneity between primary and metastatic breast tumors
Prazo: baseline
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To determine the degree of genetic heterogeneity between primary and metastatic breast tumors.
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baseline
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Colaboradores e Investigadores
Patrocinador
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- D13100
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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