EUCTR2011-000490-30-ES进行中（未招募）1 期
Phase II randomised, open-label, multicentric clinical trial of neoadjuvant treatment comprising chemotherapy and trastuzumab with or without metformin, in women with HER2/ErbB2 positive primary breast cancer.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •1. Mujeres.
- •2. Edad 18-75 años.
- •3. Puntuación 0-1 de la clasificación ECOG (Eastern Cooperative Oncology Group) (ver ApéndiceB).
- •4. Cáncer de mama invasivo confirmado histológicamente (incluido el cáncer de mama inflamatorio y el cáncer de mama multifocal:)
- •- Tumor primario mayor de 2 cm. de diámetro, medido por examen clínico y por mamografía o ecografía.
- •- Cualquier N
- •- Sin evidencia de metástasis (M0), (un ganglio supraclavicular aislado afectado está permitido).
- •Se seguirá la 7ª edición del AJCC Cancer Staging Manual (ver Apéndice C).
- •5. Sobre-expresión y/o amplificación de HER2 en el componente invasivo del tumor primario, definido según el siguiente criterio:
- •- IHC 2+ y FISH/CISH positivo
- •6. Estado conocido de los receptores hormonales.
- •7. Función hematopoyética:
- •- Recuento absoluto de neutrófilos ?1,5 x109/L
- •- Recuento de plaquetas ?100 x109/L
- •- Hemoglobina ?9 g/dl
- •8. Función hepática:
- •- Bilirrubina sérica total ?1,5 x límite superior normal (LSN).
- •- AST y ALT ?2,5 x LSN
- •- Fosfatasa alcalina ?2,5 x LSN
- •- Glucosa en ayunas ?70 mg/dl
- •9. Función renal:
- •- Creatinina?1,5 x LSNCódigo del protocolo: METTEN-01 Confidencial Versión 2 Fecha 15/05/2011 23
- •10. Cardiovascular:
- •- FEVI basal ?50% medida mediante ecocardiografía (ECO) o rastreo MUGA (del inglés, Multiple Gate Acquisition)
- •11. 20 ?IMC? 30
- •12. Prueba de embarazo negativa en los 7 días previos a la aleatorización (en las mujeres potencialmente fértiles).
- •13. Las mujeres fértiles deben utilizar un método anticonceptivo efectivo.
- •14. Consentimiento informado por escrito.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 133
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1. Prior treatment for primary invasive breast cancer.
- •2. Bilateral breast cancer.
- •3. Precedent medical history less than 10 years or present history for other malignant neoplasia, except in situ carcinoma of the cervix and basocellular and epidermoid skin carcinoma. Previous diagnosis of melanoma or breast cancer are excluded.
- •4. Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarct, uncontrolled hypertension, dyspnea at rest, or chronic therapy with oxygen.
- •5. Metabolic disease (diabetes mellitus type I or II, obesity (BMI ? 30), hyperglycemia (preprandial glucose >128 mg/dl), hypercholesterolemia or hypertrigliceridemia ? grade 3 according to CTC-NCIC version 3.0.
- •6. History of metabolic acidosis.
- •7. Chronic neumopathy or respiratory restriction.
- •8. Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient's safety.
- •9. Active or uncontrolled infection.
- •10. Enolism. (daily media consumption of more than 3 alcoholic beverage intake)
- •11. Hepatic insufficiency.
- •12. Renal insufficiency (calculated CrCl < 60 mL/min).
- •13. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent by the patient.
- •14. Malabsorption syndrome, with disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
- •15. Concurrent treatment with therapies that can alter insulin levels (including chronic treatment with oral corticoids).
- •16. Concurrent treatment with an investigational drug or participation in another therapeutic clinical trial.
- •17. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab, metformin or their excipients. Glucose or galactos absorption problems and hereditary galactose intolerance.
- •18. Pregnant or lactating women.
- •and galactosemia o hereditary galactosemia intolerance.
- •19. Sociologic, familiar or geographical conditions that may compromise clinical trial protocol compliance.
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