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S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women

13 de julio de 2018 actualizado por: Southwest Oncology Group

Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing breast cancer.

PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing breast cancer in premenopausal women who are at risk for developing the disease.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

OBJECTIVES:

  • Compare 1-year mammographic density in premenopausal women at high risk for developing breast cancer treated with celecoxib vs placebo.
  • Compare 1-year proliferation of breast epithelial cells, as measured by Ki67 staining, in patients treated with these drugs.
  • Compare the expression of other biomarkers, including cyclo-oxygenase-2 (COX-2) enzyme and a marker of apoptosis, in breast tissue of patients treated with these drugs.
  • Compare 1-year plasma levels of insulin-like growth factor (IGF)-1, IGF binding protein-3, and prostaglandin E_2 in patients treated with these drugs.
  • Compare the toxicity of these drugs in these patients.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to risk category (lobular carcinoma in situ or ductal carcinoma in situ vs BRCA1/2 mutation AND any Gail risk vs Gail risk ≥1.7% but < 5% vs Gail risk ≥ 5%) and prior tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Celocoxib: Patients receive oral celecoxib twice daily.
  • Placebo: Patients receive oral placebo twice daily. In both arms, treatment continues for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Tipo de estudio

Intervencionista

Inscripción (Actual)

8

Fase

  • Fase 2

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

  • Estados Unidos
    • California
      • Glendale, California, Estados Unidos, 91204
        • Glendale Memorial Hospital Comprehensive Cancer Center
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87131-5636
        • University of New Mexico Cancer Center
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Ben Taub General Hospital
      • Houston, Texas, Estados Unidos, 77030
        • Methodist Hospital
      • Houston, Texas, Estados Unidos, 77030
        • Veterans Affairs Medical Center - Houston
      • Houston, Texas, Estados Unidos, 77030
        • Baylor University Medical Center - Houston
      • Houston, Texas, Estados Unidos, 77030
        • St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
    • Washington
      • Seattle, Washington, Estados Unidos, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, Estados Unidos, 98195-6043
        • University Cancer Center at University of Washington Medical Center

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 120 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

DISEASE CHARACTERISTICS:

  • At elevated risk of developing breast cancer, as defined by 1 of the following:

    • Modified Gail risk at 5 years ≥ 1.7% or lifetime risk ≥ 20% AND Claus Model, BRCAPro Model, or Tyrer-Cuzick Model lifetime risk ≥ 20%
    • Diagnosis of lobular carcinoma in situ or ductal carcinoma in situ
    • Known deleterious mutation of BRCA1 or BRCA2
  • At least 1 breast available for imagery and biopsy

  • Has undergone a baseline mammogram with a standard density wedge within 7-14 days after completion of the last menstrual period AND within 7 days before study entry

    • Mammogram normal or benign (BIRADS score 0 or 1)

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Premenopausal, defined by 1 of the following criteria:

    • Last menstrual period < 6 months ago AND no prior bilateral ovariectomy AND not on estrogen replacement therapy
    • Prior hysterectomy (with ovaries still in place) AND normal follicle-stimulating hormone levels within 28 days of study entry

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin < 2.0 times institutional upper limit of normal (IULN)
  • SGOT or SGPT < 2 times IULN
  • Alkaline phosphatase < 2 times IULN
  • INR ≤ 1.5
  • PT and PTT ≤ IULN

Renal

  • Serum creatinine < 2.0 times IULN

Cardiovascular

  • No history of myocardial infarction
  • No angina pectoris
  • No known coronary artery disease
  • No history of stroke or mini-stroke (e.g., transient ischemic attack)
  • No history of thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism)
  • No uncontrolled hypertension (i.e., blood pressure > 140/90 mmHg)

Pulmonary

  • No asthma after taking aspirin or other NSAIDs

Other

  • No known sensitivity to celecoxib
  • No allergy to sulfonamides
  • No urticaria or allergic-type reactions after taking aspirin or other NSAIDs
  • No extreme lactose intolerance
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or early bladder cancer (preinvasive transitional cell carcinoma of the bladder)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 5 years since prior biologic therapy for cancer

Chemotherapy

  • More than 5 years since prior chemotherapy for cancer

Endocrine therapy

  • At least 28 days since prior tamoxifen
  • No prior systemic estrogen modifiers (SERMs) or aromatase inhibitors
  • Concurrent hormonal contraception (i.e., pills, patches, or shots) allowed provided contraception was initiated prior to study entry

Radiotherapy

  • No prior radiotherapy to the breast to be studied

Surgery

  • Not specified

Other

  • At least 7 days since prior anticoagulant therapy

  • More than 1 month since prior chronic daily aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) of more than 7 days duration

    • Concurrent intermittent aspirin or NSAIDs allowed (no more than 10 days per month)
  • No concurrent participation in another clinical trial for treatment or prevention of cancer unless no longer receiving treatment and is in the follow-up phase

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Arm I - Celecoxib
Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Droga: celecoxib
Administrado oralmente
Comparador de placebos: Arm II - Placebo
Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Otro: placebo
Administrado oralmente

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mammographic Density
Periodo de tiempo: 1 year
The primary outcome measure is change in mammographic density. The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.
1 year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Ki-67 Expression
Periodo de tiempo: 1 year
The difference between the two arms in the percent of patients with non-zero ki-67 expression over the two time periods (baseline and 1-year).
1 year

Colaboradores e Investigadores

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

Patrocinador

Southwest Oncology Group

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Silla de estudio: Powel H. Brown, MD, PhD, Baylor College of Medicine

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 noviembre de 2004

Finalización primaria (Actual)

1 de julio de 2009

Finalización del estudio (Actual)

1 de julio de 2009

Fechas de registro del estudio

Enviado por primera vez

4 de agosto de 2004

Primero enviado que cumplió con los criterios de control de calidad

4 de agosto de 2004

Publicado por primera vez (Estimar)

5 de agosto de 2004

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de agosto de 2018

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

13 de julio de 2018

Última verificación

1 de julio de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CDR0000377698
  • U10CA012027 (Subvención/contrato del NIH de EE. UU.)
  • U10CA037429 (Subvención/contrato del NIH de EE. UU.)
  • S0300 (Otro identificador: SWOG)

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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