- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00114816
Docetaxel Followed by CEF (Cyclophosphamide, Epirubicin and 5-Fluorouracil) Compared to Docetaxel and Capecitabine Followed by CEX (Cyclophosphamide, Epirubicin and Capecitabine) as Adjuvant Treatment for Breast Cancer
A Randomized Phase III Study Comparing Docetaxel Followed by Cyclophosphamide, Epirubicin and 5-FU to Docetaxel With Capecitabine Followed by Cyclophosphamide, Epirubicin and Capecitabine as Adjuvant Treatment for Early Breast Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is an open-label, two-arm, randomized multi-center phase III trial to compare efficacy and safety of a taxane-anthracycline regimen to a taxane-anthracycline-capecitabine regimen as adjuvant treatment of early breast cancer with an intermediate-to-high risk of cancer recurrence.
Patients diagnosed with early breast cancer with an estimated risk of 25% or greater for distant recurrence within 5 years from the diagnosis will be randomly allocated to one of the following 2 arms (1:1):
- Arm A -- 3 cycles of docetaxel 80 mg/m² intravenous (i.v.) (repeated on day [d.] 22); followed by 3 cycles of CEF (cyclophosphamide 600 mg/m2 i.v., epirubicin 75mg/m² i.v., 5-fluorouracil 600 mg/m2 i.v., repeated on d. 22)
- Arm B -- 3 cycles of TX (docetaxel 60 mg/m² i.v., capecitabine twice daily 900 mg/m² given orally on days 1-15 of the cycle; cycle repeated on d. 22); followed by 3 cycles of CEX (cyclophosphamide 600 mg/m2 i.v., epirubicin 75mg/m² i.v, capecitabine twice daily 900 mg/m² on days 1-15 of the cycle; cycle repeated on d. 22)
Locoregional radiotherapy is given according to the institutional practice after completing adjuvant chemotherapy (Tx3/CEFx3 or TXx3/CEXx3).
All patients with ER and/or PgR positive disease will receive adjuvant endocrine therapy. This will consist of 1 mg p.o. anastrozole (ArimidexR) given for 60 months in women who were post-menopausal prior to chemotherapy (no menstrual periods for > 6 months) or of tamoxifen 20 mg p.o. for 60 months in women who were pre-menopausal prior to chemotherapy.
Use of trastuzumab is allowed in HER-2 positive disease.
Patients will be followed up for 5 years post-randomization.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Helsinki, Finlandia, FIN-00029
- Department of Oncology, Helsinki University Central Hospital, Finland
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
To be eligible for inclusion in the study, each patient must fulfill each of the criteria below.
- Have provided written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- Be female and 18 years of age or older.
- Have histologically confirmed invasive breast cancer.
High risk of breast cancer recurrence (> 25% within the first 5 years without adjuvant therapy, > 35% within the first 10 years) with one of the following:
- Regional node positive disease (pN+; tumor cells or tumor cell clusters < 0.2 mm in diameter are not counted as metastases);
- Pathological N0 and PgR- and tumor size > 20 mm.
Exclusion Criteria:
Patients who fulfill any of the following criteria will be excluded:
- > 65 years of age.
- "Special type" histology (mucinous, papillary, medullary, or tubular breast cancer), when pN0.
- ER, PgR and HER-2 status (via in situ hybridization or immunohistochemistry) not determined.
- Presence of distant metastases.
- Previous chemotherapy in the neoadjuvant setting.
- Non-ambulatory or WHO performance status > 1.
- Pregnant or lactating women. Women of childbearing potential (menstruating within 6 months of study entry or with no hysterectomy and age < 55) with either a positive or no pregnancy test at baseline.
- Women of childbearing potential unless using a reliable and appropriate contraceptive method. (Post-menopausal women must have been amenorrheic for at least 6 months to be considered of non-childbearing potential).
- More than 12 weeks between breast surgery and date of randomization.
- Organ allografts with immunosuppressive therapy required.
- Major surgery (except breast surgery) within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
- Participation in any investigational drug study within 4 weeks preceding treatment start.
- Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
- History of another malignancy within the last five years except cured basal cell carcinoma of skin or carcinoma in situ of the uterine cervix.
- Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months.
Abnormal laboratory values:
- Hemoglobin < 10.0 g/dL, neutrophils < 1.5 x 10^9/L, platelet count < 120 x 10^9/L;
- Serum creatinine > 1.5 x Upper Limit of Normal (ULN);
- Creatinine clearance (calculated per Cockroft and Gault) < 50 mL/min;
- Serum bilirubin > ULN;
- ALAT > 1.5 x ULN;
- Alkaline phosphatase > 2.5 x ULN.
- Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
- Lack of physical integrity of the upper gastrointestinal tract or those who have clinically significant malabsorption syndrome.
- Inability to swallow tablets.
- Life expectancy of less than 3 months.
- Unwilling or unable to comply with the protocol for the duration of the study.
- Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Supervivencia libre de recurrencia
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Medidas de resultado secundarias
Medida de resultado |
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Sobrevivencia promedio
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Adverse event rate (CTCAE v. 3.0)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Heikki T Joensuu, M.D., prof., Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland
Publicaciones y enlaces útiles
Publicaciones Generales
- Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
- Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola A, Tanner M, Ahlgren J, Auvinen P, Lahdenpera O, Villman K, Nyandoto P, Nilsson G, Poikonen-Saksela P, Kataja V, Bono P, Junnila J, Lindman H. Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial. J Clin Oncol. 2022 Apr 1;40(10):1051-1058. doi: 10.1200/JCO.21.02054. Epub 2022 Jan 12.
- Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola-Vuorinen A, Tanner M, Kokko R, Ahlgren J, Auvinen P, Lahdenpera O, Kosonen S, Villman K, Nyandoto P, Nilsson G, Poikonen-Saksela P, Kataja V, Junnila J, Bono P, Lindman H. Adjuvant Capecitabine in Combination With Docetaxel, Epirubicin, and Cyclophosphamide for Early Breast Cancer: The Randomized Clinical FinXX Trial. JAMA Oncol. 2017 Jun 1;3(6):793-800. doi: 10.1001/jamaoncol.2016.6120.
- Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola-Vuorinen A, Tanner M, Asola R, Kokko R, Ahlgren J, Auvinen P, Hemminki A, Paija O, Helle L, Nuortio L, Villman K, Nilsson G, Lahtela SL, Lehtio K, Pajunen M, Poikonen P, Nyandoto P, Kataja V, Bono P, Leinonen M, Lindman H; FinXX Study Investigators. Adjuvant capecitabine in combination with docetaxel and cyclophosphamide plus epirubicin for breast cancer: an open-label, randomised controlled trial. Lancet Oncol. 2009 Dec;10(12):1145-51. doi: 10.1016/S1470-2045(09)70307-9. Epub 2009 Nov 10.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
- Mecanismos moleculares de acción farmacológica
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Docetaxel
- Capecitabina
Otros números de identificación del estudio
- FBCG Protocol No. 01-2003
- Roche protocol number MO17728
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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