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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

18 de mayo de 2007 actualizado por: Finnish Breast Cancer Group

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

This study compares two chemotherapy regimens as adjuvant treatment for breast cancer. The study participants are randomly allocated to receive either 3 cycles of docetaxel followed by 3 cycles of CEF (cyclophosphamide, epirubicin and 5-fluorouracil) or to receive 3 cycles of docetaxel plus capecitabine followed by 3 cycles of CEX (cyclophosphamide, epirubicin and capecitabine). The study participants are required to to have a medium to high risk for breast cancer recurrence. The primary aim of the study is to investigate whether addition of capecitabine to a standard taxane/anthracycline regimen will influence recurrence-free survival.

Descripción general del estudio

Estado

Terminado

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

Intervencionista

Inscripción (Anticipado)

1500

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Helsinki, Finlandia, FIN-00029
        • Department of Oncology, Helsinki University Central Hospital, Finland

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Supervivencia libre de recurrencia

Medidas de resultado secundarias

Medida de resultado
Sobrevivencia promedio
Adverse event rate (CTCAE v. 3.0)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Heikki T Joensuu, M.D., prof., Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2004

Finalización del estudio (Actual)

1 de abril de 2007

Fechas de registro del estudio

Enviado por primera vez

17 de junio de 2005

Primero enviado que cumplió con los criterios de control de calidad

17 de junio de 2005

Publicado por primera vez (Estimar)

20 de junio de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

21 de mayo de 2007

Última actualización enviada que cumplió con los criterios de control de calidad

18 de mayo de 2007

Última verificación

1 de mayo de 2007

Más información

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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Ensayos clínicos sobre docetaxel

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