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 febbraio 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
2098
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Buenos Aires, Argentina
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Capital Federal, Argentina
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Ciudad Autonoma De Buenos Airess, Argentina
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Cordoba, Argentina
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La Plata, Argentina
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Mendoza, Argentina
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Quilmes, Argentina
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Rosario, Argentina
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Santa Fe, Argentina
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Barretos, Brasile
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Curitiba, Brasile
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Goiânia/Go, Brasile
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Ijuí, Brasile
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Jau, Brasile
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Piracicaba, Brasile
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Porto Alegre, Brasile
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Ribeirão Preto/Sp, Brasile
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Santo Andre, Brasile
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Sao Paulo, Brasile
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São José Do Rio Preto, Brasile
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São Paulol, Brasile
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Arica, Chile
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Santiago, Chile
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Temuco, Chile
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Valdivia, Chile
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Valparaiso, Chile
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Bogota, Colombia
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Floridablanca-Santander, Colombia
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Monteria, Colombia
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Cuenca, Ecuador
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Guayaquil, Ecuador
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Portoviejo, Ecuador
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Quito, Ecuador
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Arkhangelsk, Federazione Russa
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Balashikha, Federazione Russa
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Belgorod, Federazione Russa
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Chelyabinsk, Federazione Russa
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Ekaterinburg, Federazione Russa
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Engels Saratov Region, Federazione Russa
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Ivanovo, Federazione Russa
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Kazan, Federazione Russa
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Krasnodar, Federazione Russa
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Leningrad Region, Federazione Russa
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Lipetsk, Federazione Russa
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Magnitogorsk, Federazione Russa
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Moscow, Federazione Russa
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Novosibirsk, Federazione Russa
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Obninsk, Federazione Russa
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Orenburg, Federazione Russa
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Perm, Federazione Russa
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Pyatigorsk, Federazione Russa
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Ryazan, Federazione Russa
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Smolensk, Federazione Russa
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St Petersburg, Federazione Russa
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St. Petersburg, Federazione Russa
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Tyumen, Federazione Russa
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Ufa, Federazione Russa
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Voronezh, Federazione Russa
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Cebu, Filippine
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Davao City, Filippine
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Iloilo City, Filippine
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Manila, Filippine
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Quezon City, Filippine
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Batumi, Georgia
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Tbilisi, Georgia
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Tblisi, Georgia
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New Territories, Hong Kong
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Ahmedabad, India
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Andra Pradesh, India
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Bangalore, India
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Bangalore N/A, India
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Bhopal, India
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Cochin, India
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Delhi, India
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Hyderabad, India
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Jaipur, India
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Karnad, India
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Kerala, India
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Kolkata, India
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Mangalore, India
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Mumbai, India
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Nashik, India
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New Delhi, India
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Pune, India
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Tamil Nadu, India
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Tamil Nadu Na, India
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Thiruvananthapuram, India
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Uttar Pradesh, India
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Vellore, India
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Bandung, Indonesia
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Jakarta, Indonesia
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Semarang, Indonesia
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Yogyakarta, Indonesia
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Bitola, Macedonia, ex Repubblica iugoslava di
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Skopje, Macedonia, ex Repubblica iugoslava di
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Georgetown, Malaysia
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Kelantan, Malaysia
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Kuala Lumpur, Malaysia
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Nilai, Malaysia
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Tanjung Bunga, Malaysia
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Chihuahua, Messico
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Guerrero, Messico
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Leon, Messico
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Merida, Messico
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Morelia, Messico
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Puebla, Messico
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San Luis Potosi, Messico
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Sinaloa, Messico
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Zapopan, Messico
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Białystok, Polonia
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Gdansk, Polonia
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Gliwice, Polonia
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Katowice N/A, Polonia
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Kraków, Polonia
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Lodz, Polonia
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Olsztyn, Polonia
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Poznan, Polonia
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Wroclaw, Polonia
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Brasov, Romania
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Bucuresti, Romania
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Cluj-Napoca, Romania
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Iasi, Romania
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Onesti, Romania
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Sibiu, Romania
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Suceava, Romania
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Timisoara, Romania
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California
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Anaheim, California, Stati Uniti
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Florida
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Gainesville, Florida, Stati Uniti
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Miami, Florida, Stati Uniti
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New Port Richey, Florida, Stati Uniti
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Rockledge, Florida, Stati Uniti
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Kentucky
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Hazard, Kentucky, Stati Uniti
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Louisiana
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Alexandria, Louisiana, Stati Uniti
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Marrero, Louisiana, Stati Uniti
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Mississippi
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Jackson, Mississippi, Stati Uniti
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New York
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Lake Success, New York, Stati Uniti
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Staten Island, New York, Stati Uniti
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti
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Texas
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Corpus Christi, Texas, Stati Uniti
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Houston, Texas, Stati Uniti
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Bloemfontein, Sud Africa
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Cape Town, Sud Africa
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Durban, Sud Africa
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Johannesburg, Sud Africa
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Klerksdorp, Sud Africa
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Port Elizabeth N/A, Sud Africa
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Pretoria, Sud Africa
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Changhua, Taiwan
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Chiayi, Taiwan
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Hualien, Taiwan
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Kaohsiung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei 112, Taiwan
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Tao-Yuan, Taiwan
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Cherkassy, Ucraina
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Chernihiv, Ucraina
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Chernivtsi, Ucraina
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Dnepropetrovsk, Ucraina
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Donetsk, Ucraina
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Ivano-Francovsk, Ucraina
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Kharkiv, Ucraina
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Kiev, Ucraina
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Lviv, Ucraina
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Odessa, Ucraina
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Poltava, Ucraina
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Sumy, Ucraina
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Uzhgorod, Ucraina
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Vinnitsa, Ucraina
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Vinnytsia, Ucraina
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Zaporozhye, Ucraina
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 99 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 001
epoetin alfa + packed RBC transfusion 40 000 IU SC once a week.
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40,000 IU SC once a week.
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Altro: 002
Standard supportive care (packed RBC transfusion) Per doctor prescription
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Per doctor prescription
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Progression Free Survival
Lasso di tempo: From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)
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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.
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From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Overall Survival
Lasso di tempo: 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.
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From randomization up to death from any cause (up to 8.4 years)
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Time to Tumor Progression
Lasso di tempo: From date of randomization to the date of the first documented PD (up to 8.4 years)
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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).
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From date of randomization to the date of the first documented PD (up to 8.4 years)
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Overall Response Rate (ORR)
Lasso di tempo: every 8 weeks for 1 year and then every 12 weeks until PD or death, whichever occurred first (up to 8.4 years)
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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.
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every 8 weeks for 1 year and then every 12 weeks until PD or death, whichever occurred first (up to 8.4 years)
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Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs)
Lasso di tempo: up to 8.4 years
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Suspected TVEs were identified by investigators and relevant clinical information was collected.
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up to 8.4 years
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
2 marzo 2006
Completamento primario (Effettivo)
7 luglio 2014
Completamento dello studio (Effettivo)
31 gennaio 2017
Date di iscrizione allo studio
Primo inviato
16 giugno 2006
Primo inviato che soddisfa i criteri di controllo qualità
16 giugno 2006
Primo Inserito (Stima)
20 giugno 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 marzo 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 febbraio 2018
Ultimo verificato
1 febbraio 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CR005143 (Altro identificatore: Janssen Research & Development, LLC)
- EPOANE3010 (Altro identificatore: Janssen Research & Development, LLC)
- 2005-001817-17 (Numero EudraCT: Janssen Research & Development, LLC)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .