EUCTR2007-002942-40-ES进行中（未招募）不适用
EXPLORATORY STUDY OF THE EFFECT OF THREE DIFFERENT LEVELS OF DOSES OF TAMOXIFEN (20, 40 Y 60 MG/DAY) OVER THE PLASMATIC CONCENTRATION OF THE MAIN ACTIVE TAMOXIFEN METABOLITE (ENDOXIFEN) IN PATIENTS WITH HORMONO-SENSITIVE BREAST CANCER, CARRIERS OF A CYP2D6 GENOTYPE POOR METABOLIZER”.Estudio exploratorio del efecto de tres diferentes niveles de dosis de tamoxifeno (20, 40 y 60 mg/día) sobre la concentración plasmática de su principal metabolito activo (endoxifeno) en pacientes con cáncer de mama hormonodependiente portadoras de un genotipo de CYP2D6 metabolizador lento”
Fundación de la Comunidad Valenciana Hospital Provincial de Castellón0 个研究点开始时间: 2007年9月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for enrollement into the trial:
- •·Female,18 years of age or older.
- •·Karnofsky performance score = 80.
- •·Histologically proven diagnosis of hormone-dependent breast cancer, stage I, II, or III (T1-3, Nx, M0), without evidence of metastatic disease.
- •·Patient must have received definitive surgery treatment for breast cancer ( lumpectomy or mastectomy) and must have completed adjuvant or neo-adjuvant therapy if indicated.
- •·Adjuvant treatment with tamoxifen must be indicated. At the inclusion time, the patient can be about starting the endocrine therapy or can have yet started it, but in this last case it must be planned to continue this treatment for at least 8 months more.
- •·Patient with variant forms of the CYP2D6 gene corresponding to a poor metabolim of CYP2D6, as defined in ANEXO 2.
- •·Women of childbearing potencial must be using a medically accepted method of contraception. Postmenopausic women (non-histerectomized) must remain amenorrheic during at least 12 months to be considered infertile (or at least 24 months in case of amenorrhea induced by adjuvant chemotherapy.
- •·Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days before study inclusion.
- •·Adequate haematological function as defined by haemoglobin >10g/dL, absolute neutrophil count >
- •> 1,5 x 109/L, platelet count > 100 x 109/L); Adequate hepatic function as defined by: (ASAT/SGOT, ALAT/SGPTand alxaline phosphatase < 2,5 x ULN, total bilirubin < 2,5 mg/dl) and adequate renal function as defined by: creatinine < 2.0 mg/dl (within 15 days before inclusion).
- •·Normal ECG (or without clinically relevant abnormality) within 8 weeks before inclusion.
- •·Normal X-Ray (or without clinically relevant abnormality) within 8 weeks before inclusion.
- •·Patients must sign written informed consent to performance the CYP2D6 genotype testing. Afterwards, if patient is eligible, she ought to sign a written informed consent to participate in the clinical trial in the 15 days prior to the inclusion.
- •9.4.Criterios de inclusión
- •1.Mujeres ³ 18 años.
- •2.Índice del estado funcional de Karnofsky = 80 (ECOG 0,1).
- •3.Diagnóstico de cáncer de mama histológicamente demostrado y hormonosensible (con receptores de estrógeno (RE) y/o receptores de progesterona (RPg) positivos), con estadio I, II o III (T1-3, M0), sin evidencia de diseminación a distancia.
- •4.La paciente debe haber recibido un tratamiento quirúrgico definitivo para el cáncer de mama operable, bien mastectomía o bien cirugía conservadora, y debe haber completado el tratamiento quimioterápico adyuvante (o neoadyuvante) si éste estuviera indicado.
- •5.El tratamiento hormonal adyuvante con tamoxifeno debe estar indicado. En el momento de la inclusión en el estudio la paciente puede estar pendiente de iniciar la terapia hormonal o puede haberla iniciado ya, pero en este último caso debe estar planeado continuar la administración de tamoxifeno durante al menos 8 meses más.
- •6.Pacientes con un genotipo de CYP 2D6 metabolizador lento”, según la definición recogida en el ANEXO 2.
- •7.Las mujeres en edad fértil deben utilizar un método anticonceptivo fiable y apropiado. Las mujeres postmenopáusicas (no histerectomizadas) deben haber permanecido amenorreicas durante al menos 12 meses para ser consideradas como no fértiles (o al menos 24 meses si la amenorrea ha sido inducida por el tratamiento quimioterápico adyuvante).
排除标准
- •Patient with estrogen receptor AND progesterone receptor both negative breast cancer.
- •Patients for whom tamoxifen is contraindicated ( history of deep vein thrombosis, endometrial hyperplasia, or abnormal vaginal bleeding), or known hypersensitivity to tamoxifen.
- •Pregnant or breast feeding women. Patients of childbearing potential and serum or urine pregnancy test unknown or positive within 14 days before inclusion.
- •Patients concurrently receiving any other hormone therapy or anti-cancer therapy.
- •Concomitant treatment for hot flushes and sweats.
- •Concurrent treatment with strong inhibitors of CYP2D6 as the selective inhibitors of serotonine Reuptake SSRI (particularly paroxetine y fluoxetine) or other less potent inhibitors of CYP2D6 (as sertraline and citalopram among the SSRI, doxepine, celecoxib, difenhidramine, clorfeniramine, amiodarone, cimetidine, haloperidol y ticlopidine).
- •Concomitant oral treatment with coumarin-derivative anticoagulant therapy.
- •Patients not willing or not being able to compliance with the protocol.
- •9.5.Criterios de exclusión
- •1.Pacientes con tumores con receptores de estrógeno (RE) y receptores de progesterona ambos negativos.
- •2.Mujeres con contraindicación para recibir tamoxifeno (antecedentes de enfermedad tromboembólica, hiperplasia endometrial o síntomas ginecológicos anormales como metrorragia), así como hipersensibilidad conocida a tamoxifeno.
- •3.Pacientes embarazadas o en período de lactancia. Pacientes con potencial de fertilidad y un resultado desconocido o positivo en la prueba de embarazo en orina o suero, realizada en los 14 días anteriores a la inclusión en el estudio.
- •4.Tratamiento concomitante con otra terapia hormonal sistémica, o con fármacos citotóxicos.
- •5.Tratamiento médico concomitante para los sofocos o acaloradas postmenopáusicas.
- •6.Tratamiento concomitante con inhibidores potentes de CYP2D6 como los inhibidores selectivos de la recaptación de serotonina (ISRS, especialmente paroxetina y fluoxetina) u otros inhibidores menos potentes de CYP2D6 (como sertralina y citalopram entre los ISRS, doxepina, celecoxib, difenhidramina, clorfeniramina, amiodarona, cimetidina, haloperidol y ticlopidina).
- •7.Pacientes con tratamiento anticoagulante con derivados de cumarina.
- •8.Pacientes que no quieran o no puedan cumplir con el protocolo.
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