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Retrospective Analysis of Effectiveness and Safety Profile of Anastrozole and Letrozole in HR+ Breast Cancer Patients

Retrospective Analysis of Effectiveness and Safety Profile of Anastrozole and Letrozole in Adjuvant Treatment of HR+ Early Breast Cancer Patients

This is a single centre, observational and retrospective clinical study. The study group was about all HR positive postmenopausal breast cancer patients who were hospitalized between January, 2008 and October, 2010, and ever accepted AI therapy with the completed follow-up data.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

The department of surgery at Tian Jin Medical University Cancer Hospital, one of the centers of excellence to treat patients with breast cancer in China, collects and maintains an electronic database of patients treatment details and follow up data. This is a single centre, observational and retrospective clinical study. The study group was about all HR positive postmenopausal breast cancer patients who were hospitalized between January, 2008 and October, 2010, and ever accepted AI therapy with the completed follow-up data.All the enrolled patients received breast-conserving surgery or whole breast surgery, and afterwards, received adjuvant chemotherapy according the pathological types. The patient's clinical pathological data include the age, family history, surgery options, pathologic type, the size of tumor, lymph node status, histological grade, chemotherapy regime, irradiation regime, and the expressions pattern of Her-2 and Ki-67. The research starts when the patients received the first time AI treatment. In the subsequent treatment, we analyzed the patients' bone density changes (T value >-1 indicates normal,-2.5≤T value≤-1 indicates mild osteoporosis, T value <-2.5 indicates severe osteoporosis) each half year for 3 years, analyzed the patients' liver function and kidney function changes each half year for 3 years (AST, ALT, ALP, TBIL, DBIL,UREA and CREA values > 2 times ULN indicates abnormal), analyzed the patients' blood-lipoids (LDL, HDL, TG and TC) each half year for 3 years, the occurrence rates of adverse reactions (skin flush, joint pain, headache, rash, nausea, vomiting, diarrhea, et al), the causes and rates of treatment termination between the 2 groups, the 3 years DFS and OS between two groups, and the factors associated with survival and prognosis, and identified the benefit individuals of AI therapy.

Tipo de estudio

De observación

Inscripción (Anticipado)

1000

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

60 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra de probabilidad

Población de estudio

This is a single centre, observational and retrospective clinical study.The study group was about all HR positive postmenopausal breast cancer patients,and ever accepted AI therapy with the completed follow-up data. The patient's clinical pathological data include the age, family history, surgery options, pathologic type,et al. We analyzed the patients' bone density changes, liver function and kidney function changes,and analyzed the patients' blood-lipoids each half year for 3 years, the occurrence rates of adverse reactions, the causes and rates of treatment termination between the 2 groups, the 3 years DFS and OS between two groups, and the factors associated with survival and prognosis, and identified the benefit individuals of AI therapy.

Descripción

Inclusion Criteria:

  • 1). Breast cancer confirmed by histology or cytology with the tumor complete resection 2). ER and /or PR positive 3). Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria (based on the NCCN definition of menopause [National Comprehensive Cancer Network 2008]):

    1. Prior bilateral oophorectomy;
    2. Age ≥ 60 years;
    3. Age < 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and plasma FSH and estradiol in the postmenopausal range; if taking tamoxifen or toremifene, and age<60 years, then serial measurement of plasma FSH and estradiol are need to ensure in the postmenopausal ranges.

      4). Patients have received regular anastrozole or letrozole adjuvant treatment 6). The values of AST, ALT, ALP, TBIL, UREA, CREA were less than 2 times of ULN at the beginning of AI therapy.

      7). BMD T >-1 at baseline.

      Exclusion Criteria:

  • Any of the following is regarded as a criterion for exclusion from the study:

    1. . Previous use of the other AIs except for anastrozole or letrozole
    2. . Any severe concomitant condition before AI treatment: uncontrolled cardiac disease or uncontrolled diabetes mellitus et al.

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

Cohortes e Intervenciones

Grupo / Cohorte
Anastrozole treatment group
The study group was about HR positive postmenopausal breast cancer patients who were hospitalized between January, 2008 and October, 2010, and ever accepted anastrozole therapy with the completed follow-up data.
letrozole treatment group
The study group was about HR positive postmenopausal breast cancer patients who were hospitalized between January, 2008 and October, 2010, and ever accepted letrozole therapy with the completed follow-up data.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Compare the proportion of patients with abnormal biochemical test results including liver function, kidney function, blood-lipoids, bone density index.
Periodo de tiempo: one year
one year

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
To explore the proportion of patients discontinue AI treatment and reasons related to these discontinuation.
Periodo de tiempo: one year
one year
To explore the 3-year DFS rate among the people under upfront therapy.
Periodo de tiempo: one year
one year
To explore the 3-year OS rate among the people under upfront therapy.
Periodo de tiempo: one year
one year
To explore the DFS in the patients who quit treating.
Periodo de tiempo: one year
one year
To explore the OS in the patients who quit treating.
Periodo de tiempo: one year
one year

Colaboradores e Investigadores

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

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 julio de 2016

Finalización primaria (Anticipado)

1 de julio de 2017

Finalización del estudio (Anticipado)

1 de noviembre de 2017

Fechas de registro del estudio

Enviado por primera vez

15 de mayo de 2016

Primero enviado que cumplió con los criterios de control de calidad

21 de junio de 2016

Publicado por primera vez (Estimar)

24 de junio de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de junio de 2016

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

21 de junio de 2016

Última verificación

1 de abril de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • bc2015014

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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