- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00963729
Chemotherapy or Letrozole Before Surgery in Treating Postmenopausal Women With Breast Cancer That Can Be Removed By Surgery
A Neoadjuvant Study of Chemotherapy Versus Endocrine Therapy in Postmenopausal Patients With Primary Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. It is not yet known whether giving more than one drug (combination chemotherapy) or giving letrozole before surgery is more effective in treating women with breast cancer.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy before surgery to see how well it works compared with letrozole given before surgery in treating postmenopausal women with breast cancer that can be removed by surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- To compare the efficacy and tolerability of cytotoxic chemotherapy versus aromatase inhibition for the down-staging of strongly ER+ primary breast cancer in postmenopausal women.
- To identify biological predictors of response to these two treatment modalities.
OUTLINE: This is a multicenter pilot, feasibility study followed by a randomized study. In the pilot study, a record of all patients screened and invited to participate in the study is compiled. Reasons for failure to recruit will be recorded. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who do not achieve at least partial response after 3 courses receive docetaxel IV on day 1 of 3-week courses for an additional 3 courses.
- Arm II: Patients receive oral letrozole daily for 18-23 weeks until day of surgery.
Patients in both arms undergo surgery at week 18-23. Most patients then receive adjuvant therapy.
Quality of life is assessed at baseline, periodically during study treatment, and then during follow up.
Blood is collected pre-treatment, at mid-treatment, and before surgery. Blood is then collected every 6 months for 2 years. Blood samples and preserved tumor samples are used for correlative studies.
After completion of surgery, patients are followed up at least annually for 10 years.
PROJECTED ACCRUAL: A total of 40 patients for the pilot study and 716 patients for the phase III study will be accrued.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Seoul, Corea, república de, 138-736
- Asan Medical Center - University of Ulsan College of Medicine
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England
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Isleworth, England, Reino Unido, TW7 6AF
- West Middlesex University Hospital
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London, England, Reino Unido, W6 8RF
- Charing Cross Hospital
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London, England, Reino Unido, W2 1NY
- St. Mary's Hospital
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London, England, Reino Unido, SE1 9RT
- Guy's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically proven primary invasive breast cancer that is thought to be suitable for neoadjuvant treatment
- No cytological proof of malignancy only
- T2 tumor or greater (≥ 20 mm by ultrasound) or any T stage with nodal disease ≥ 20 mm diameter on ultrasound assessment
- No evidence of distant metastatic disease as disclosed by bone scan, liver, and chest imaging
- Definite indication for neoadjuvant and adjuvant chemotherapy
- Primary tumor amenable to biopsy
- No inoperable disease that is judged very unlikely to be rendered operable by neoadjuvant treatment
- No inflammatory breast cancer
- No bilateral invasive breast cancer
- HER-2 positivity is NOT an exclusion criterion in the feasibility (pilot) study
Estrogen receptor (ER) positive tumor
- No ER-poor disease as defined locally (e.g., H-score < 100, Allred 3/4/5)
- Allred 6/7/8, H-score H ≥100 allowed
PATIENT CHARACTERISTICS:
Postmenopausal, meeting 1 of the following criteria:
- Over 12 months since last menstrual period
- Postmenopausal gonadotrophin levels (luteinizing hormone or follicle-stimulating hormone levels above local criteria)
- Postmenopausal estradiol levels below local criteria
- Prior bilateral oophorectomy
- Menopause induced by gonadotrophin-releasing hormone not allowed
- WHO performance status 0 or 1
- WBC ≥ 3.0 × 10^9/L
- ANC ≥ 1.5 × 10^9/L
- Platelets ≥ 100 × 10^9/L
- Hemoglobin > 9 g/dL
- AST/ALT ≤ 1.5 times upper limit of normal (ULN)
- Serum bilirubin ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 1.5 times ULN
- Serum creatinine ≤ 1.5 times ULN
- No active, uncontrolled infection
No malignancy within the past 10 years except for basal cell carcinoma or cervical carcinoma in situ
- Treatment for previous malignancy confined to resection alone
- No concomitant medical, psychiatric, or geographic problems that might prevent completion of treatment or follow-up
- No known severe hypersensitivity to aromatase inhibitors
- No contraindication to receiving aromatase inhibitors (clinical evidence or recorded history of osteoporosis)
No other serious illness or medical condition including any of the following:
- Congestive heart failure or unstable angina pectoris
- Myocardial infarction within the past year
- Uncontrolled hypertension or high-risk uncontrolled arrhythmias
- History of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures, that would prohibit the understanding and giving of informed consent
- Active peptic ulcer
- Unstable diabetes mellitus
- No definite contraindications for the use of corticosteroids
- No contraindication to receiving combination anthracycline/taxane chemotherapy
- Willing to undergo repeat biopsies
PRIOR CONCURRENT THERAPY:
- No hormone replacement therapy within 4 weeks of starting treatment
- No chronic oral treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone or equivalent)
- No concurrent warfarin or heparin therapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Arm I
Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1.
Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Dado IV
Dado IV
Dado IV
Dado IV
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Experimental: Arm II
Patients receive oral letrozole daily for 18-23 weeks until day of surgery.
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Administrado oralmente
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Feasibility of patient recruitment (pilot)
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Feasibility of tissue collection (pilot)
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Ultrasound (or mammogram) response rate
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Medidas de resultado secundarias
Medida de resultado |
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Sobrevivencia promedio
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Calidad de vida
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Supervivencia libre de enfermedad
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Tasa de respuesta clínica
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Radiologic response rate by ultrasound (pilot)
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Pathological complete response rate (pCR) defined as no residual invasive or pre-invasive carcinoma in breast or axilla (pilot)
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Plasma DNA changes in relation to treatment response
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Rate of conservation surgery
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Degree of pathological response
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Ki-67 changes and its relationship to treatment response
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Length of time to maximum response within the treatment period
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Tolerability of the various treatments
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MRI response
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de la piel
- Neoplasias
- Neoplasias por sitio
- Enfermedades de los senos
- Neoplasias de mama
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antirreumáticos
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Antibióticos, Antineoplásicos
- Antagonistas de hormonas
- Inhibidores de la aromatasa
- Inhibidores de la síntesis de esteroides
- Antagonistas de estrógeno
- Docetaxel
- Ciclofosfamida
- Fluorouracilo
- Epirubicina
- Letrozol
Otros números de identificación del estudio
- ICCRU-NEOcent-C-21-07
- CDR0000641383 (Identificador de registro: PDQ (Physician Data Query))
- EU-20936
- EUDRACT-2006-003596-12
- ISRCTN77234840
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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