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A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy

15 de febrero de 2018 actualizado por: Janssen Research & Development, LLC

A Randomized, Open-label, Multicenter, Phase 3 Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy

The purpose of this study is to assess the impact on tumor progression as evaluated by progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating anemia according to label guidance in patients with metastatic breast cancer receiving standard chemotherapy.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Anemia is a common complication of the treatment of metastatic breast cancer and is related to the effects of chemotherapy and to chronic disease itself. This is a randomized, open-label, multicenter, international study to further examine the safety of the study drug used with standard supportive care (i.e., packed RBC transfusions) compared to standard supportive care alone, when used to treat anemia associated with chemotherapy. This study will be done in subjects with metastatic breast cancer who are being or will be treated with first-line chemotherapy with standard dose schedules of taxane monotherapy, or a taxane plus trastuzumab, or an anthracycline plus either a taxane or cyclophosphamide. The study hypothesis is that epoetin alfa, when used as supportive anemia care, does not increase the risk of tumor progression or death. The study treatment will be compared to the control treatment by comparing progression-free survival, i.e., the number of months from the date a patient is randomized into the trial to the date of the first documented disease progression or death. In addition to their chemotherapy, half of the subjects will be assigned to receive study drug (epoetin alfa) and half of the subjects will be assigned to standard supportive care for anemia. Subjects treated with the study drug will receive standard supportive care (packed RBC transfusions) plus 40,000 IU epoetin alfa given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until disease progression, whichever comes first.The hypothesis is to test that epoetin alfa, when used as supportive anemia care, is non-inferior to control (standard supportive care alone), as measured by progression free survival (PFS). Patients treated with the study drug will receive standard supportive care (packed red blood cells (RBC) transfusions) plus 40,000 IU epoetin alfa given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until disease progression, whichever comes first. Dose adjustments (dose escalation, dose reduction, dose interruption, and dose resumption) of epoetin alfa will be based on hemoglobin (Hb) and confirm to prescribing information.

Tipo de estudio

Intervencionista

Inscripción (Actual)

2098

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

  • Argentina
      • Buenos Aires, Argentina
      • Capital Federal, Argentina
      • Ciudad Autonoma De Buenos Airess, Argentina
      • Cordoba, Argentina
      • La Plata, Argentina
      • Mendoza, Argentina
      • Quilmes, Argentina
      • Rosario, Argentina
      • Santa Fe, Argentina
  • Brasil
      • Barretos, Brasil
      • Curitiba, Brasil
      • Goiânia/Go, Brasil
      • Ijuí, Brasil
      • Jau, Brasil
      • Piracicaba, Brasil
      • Porto Alegre, Brasil
      • Ribeirão Preto/Sp, Brasil
      • Santo Andre, Brasil
      • Sao Paulo, Brasil
      • São José Do Rio Preto, Brasil
      • São Paulol, Brasil
  • Bulgaria
      • Plovdiv, Bulgaria
      • Rousse, Bulgaria
      • Sofia, Bulgaria
      • Stara Zagora, Bulgaria
      • Varna, Bulgaria
  • Chile
      • Arica, Chile
      • Santiago, Chile
      • Temuco, Chile
      • Valdivia, Chile
      • Valparaiso, Chile
  • Colombia
      • Bogota, Colombia
      • Floridablanca-Santander, Colombia
      • Monteria, Colombia
  • Ecuador
      • Cuenca, Ecuador
      • Guayaquil, Ecuador
      • Portoviejo, Ecuador
      • Quito, Ecuador
  • Estados Unidos
    • California
      • Anaheim, California, Estados Unidos
    • Florida
      • Gainesville, Florida, Estados Unidos
      • Miami, Florida, Estados Unidos
      • New Port Richey, Florida, Estados Unidos
      • Rockledge, Florida, Estados Unidos
    • Kentucky
      • Hazard, Kentucky, Estados Unidos
    • Louisiana
      • Alexandria, Louisiana, Estados Unidos
      • Marrero, Louisiana, Estados Unidos
    • Mississippi
      • Jackson, Mississippi, Estados Unidos
    • New York
      • Lake Success, New York, Estados Unidos
      • Staten Island, New York, Estados Unidos
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos
    • Texas
      • Corpus Christi, Texas, Estados Unidos
      • Houston, Texas, Estados Unidos
  • Federación Rusa
      • Arkhangelsk, Federación Rusa
      • Balashikha, Federación Rusa
      • Belgorod, Federación Rusa
      • Chelyabinsk, Federación Rusa
      • Ekaterinburg, Federación Rusa
      • Engels Saratov Region, Federación Rusa
      • Ivanovo, Federación Rusa
      • Kazan, Federación Rusa
      • Krasnodar, Federación Rusa
      • Leningrad Region, Federación Rusa
      • Lipetsk, Federación Rusa
      • Magnitogorsk, Federación Rusa
      • Moscow, Federación Rusa
      • Novosibirsk, Federación Rusa
      • Obninsk, Federación Rusa
      • Orenburg, Federación Rusa
      • Perm, Federación Rusa
      • Pyatigorsk, Federación Rusa
      • Ryazan, Federación Rusa
      • Smolensk, Federación Rusa
      • St Petersburg, Federación Rusa
      • St. Petersburg, Federación Rusa
      • Tyumen, Federación Rusa
      • Ufa, Federación Rusa
      • Voronezh, Federación Rusa
  • Filipinas
      • Cebu, Filipinas
      • Davao City, Filipinas
      • Iloilo City, Filipinas
      • Manila, Filipinas
      • Quezon City, Filipinas
  • Georgia
      • Batumi, Georgia
      • Tbilisi, Georgia
      • Tblisi, Georgia
  • Hong Kong
      • New Territories, Hong Kong
  • India
      • Ahmedabad, India
      • Andra Pradesh, India
      • Bangalore, India
      • Bangalore N/A, India
      • Bhopal, India
      • Cochin, India
      • Delhi, India
      • Hyderabad, India
      • Jaipur, India
      • Karnad, India
      • Kerala, India
      • Kolkata, India
      • Mangalore, India
      • Mumbai, India
      • Nashik, India
      • New Delhi, India
      • Pune, India
      • Tamil Nadu, India
      • Tamil Nadu Na, India
      • Thiruvananthapuram, India
      • Uttar Pradesh, India
      • Vellore, India
  • Indonesia
      • Bandung, Indonesia
      • Jakarta, Indonesia
      • Semarang, Indonesia
      • Yogyakarta, Indonesia
  • Macedonia, la ex República Yugoslava de
      • Bitola, Macedonia, la ex República Yugoslava de
      • Skopje, Macedonia, la ex República Yugoslava de
  • Malasia
      • Georgetown, Malasia
      • Kelantan, Malasia
      • Kuala Lumpur, Malasia
      • Nilai, Malasia
      • Tanjung Bunga, Malasia
  • México
      • Chihuahua, México
      • Guerrero, México
      • Leon, México
      • Merida, México
      • Morelia, México
      • Puebla, México
      • San Luis Potosi, México
      • Sinaloa, México
      • Zapopan, México
  • Polonia
      • Białystok, Polonia
      • Gdansk, Polonia
      • Gliwice, Polonia
      • Katowice N/A, Polonia
      • Kraków, Polonia
      • Lodz, Polonia
      • Olsztyn, Polonia
      • Poznan, Polonia
      • Wroclaw, Polonia
  • Rumania
      • Brasov, Rumania
      • Bucuresti, Rumania
      • Cluj-Napoca, Rumania
      • Iasi, Rumania
      • Onesti, Rumania
      • Sibiu, Rumania
      • Suceava, Rumania
      • Timisoara, Rumania
  • Sudáfrica
      • Bloemfontein, Sudáfrica
      • Cape Town, Sudáfrica
      • Durban, Sudáfrica
      • Johannesburg, Sudáfrica
      • Klerksdorp, Sudáfrica
      • Port Elizabeth N/A, Sudáfrica
      • Pretoria, Sudáfrica
  • Taiwán
      • Changhua, Taiwán
      • Chiayi, Taiwán
      • Hualien, Taiwán
      • Kaohsiung, Taiwán
      • Taichung, Taiwán
      • Tainan, Taiwán
      • Taipei, Taiwán
      • Taipei 112, Taiwán
      • Tao-Yuan, Taiwán
  • Ucrania
      • Cherkassy, Ucrania
      • Chernihiv, Ucrania
      • Chernivtsi, Ucrania
      • Dnepropetrovsk, Ucrania
      • Donetsk, Ucrania
      • Ivano-Francovsk, Ucrania
      • Kharkiv, Ucrania
      • Kiev, Ucrania
      • Lviv, Ucrania
      • Odessa, Ucrania
      • Poltava, Ucrania
      • Sumy, Ucrania
      • Uzhgorod, Ucrania
      • Vinnitsa, Ucrania
      • Vinnytsia, Ucrania
      • Zaporozhye, Ucrania

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 99 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Histologically confirmed (e.g., slide of tissue) breast cancer
  • HER2/NEU positive or negative
  • Clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (M1) lesion prior to starting the current chemotherapy
  • Received 1st and 2nd line chemotherapy
  • Hemoglobin (Hb) <= 11g/dL at the time of randomization
  • planned to receive at least 2 more cycles of chemotherapy
  • Life expectancy > 6 months
  • Eastern Cooperative Oncology Group score 0 or 1
  • At least 18 years old using effective birth control or surgically sterile or postmenopausal for 1 year

Exclusion Criteria:

  • Active second cancer
  • no recent history of clinically relevant thrombovascular event
  • Current treatment with anticoagulants
  • Brain metastasis or CNS involvement
  • Anemia secondary to another cause
  • Recent (within prior 1 months) use of an ESA
  • Patient pregnant or breast feeding
  • Progressive disease during adjuvant/neoadjuvant chemotherapy
  • Rapidly progressive or life-threatening metastatic disease
  • Concomitant endocrine therapy
  • Patient in whom the only site of metastasis was local and was successfully treated surgically.

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)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 001
epoetin alfa + packed RBC transfusion 40 000 IU SC once a week.
Droga: epoetin alfa + packed RBC transfusion
40,000 IU SC once a week.
Otro: 002
Standard supportive care (packed RBC transfusion) Per doctor prescription
Otro: Standard supportive care (packed RBC transfusion)
Per doctor prescription

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression Free Survival
Periodo de tiempo: From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)
Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.
From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival
Periodo de tiempo: From randomization up to death from any cause (up to 8.4 years)
Overall survival (OS) was defined as the interval between the date of randomization to the date of death from any cause. For participants who were lost to follow-up or withdrew before the final database lock, OS was censored at the last date the participants was known to be alive. For participants who were still alive and on study at the time of the final database lock, OS was censored at the date of final database lock.
From randomization up to death from any cause (up to 8.4 years)
Time to Tumor Progression
Periodo de tiempo: From date of randomization to the date of the first documented PD (up to 8.4 years)
The Time to tumor progression (TTP) was defined as the time from the date of starting treatment until the date of first documented evidence of progression of tumor. TTP was measured from the date of randomization to the date of the first documented PD (including death due to PD without prior PD).
From date of randomization to the date of the first documented PD (up to 8.4 years)
Overall Response Rate (ORR)
Periodo de tiempo: every 8 weeks for 1 year and then every 12 weeks until PD or death, whichever occurred first (up to 8.4 years)
Overall response was RECIST criteria. Complete response (CR) is appearance of all target and non-target lesions. Partial response (PR):a) 30% decrease in sum of lactate dehydrogenase(LD) of target lesions from baseline OR b) complete disappearance of target lesions, with persistence of one or more non-target measurable lesion or one or more non-measurable, evaluable lesions. Progressive disease(PD):a) 20% increase in sum of LDs of target lesions, taking as reference smallest sum LD recorded since treatment started; OR b) appearance of one or more new lesions or a clear worsening of measurable non-target lesions or evaluable disease with stable measurable lesions. Stable disease (SD):a) sufficient shrinkage to qualify for PR;b) sufficient increase to qualify for PD. Non evaluable(NE) lesion: all other lesions, including small lesions (longest diameter <20 millimeter (mm) with conventional techniques or <10 mm with spiral CT scan) and truly non-measurable lesions.
every 8 weeks for 1 year and then every 12 weeks until PD or death, whichever occurred first (up to 8.4 years)
Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs)
Periodo de tiempo: up to 8.4 years
Suspected TVEs were identified by investigators and relevant clinical information was collected.
up to 8.4 years

Colaboradores e Investigadores

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

Patrocinador

Janssen Research & Development, LLC

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 (Actual)

2 de marzo de 2006

Finalización primaria (Actual)

7 de julio de 2014

Finalización del estudio (Actual)

31 de enero de 2017

Fechas de registro del estudio

Enviado por primera vez

16 de junio de 2006

Primero enviado que cumplió con los criterios de control de calidad

16 de junio de 2006

Publicado por primera vez (Estimar)

20 de junio de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de marzo de 2018

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

15 de febrero de 2018

Última verificación

1 de febrero de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CR005143 (Otro identificador: Janssen Research & Development, LLC)
  • EPOANE3010 (Otro identificador: Janssen Research & Development, LLC)
  • 2005-001817-17 (Número EudraCT: Janssen Research & Development, LLC)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

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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