A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
19. prosince 2012 aktualizováno: Hoffmann-La Roche
A Randomized, Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer
This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer.
Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle.
The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
2611
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Texas
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Houston, Texas, Spojené státy, 77060
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 70 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
Inclusion Criteria:
- female patients 18-70 years of age;
- adenocarcinoma of the breast;
- previous invasive breast cancer if diagnosed >5 years before entering study;
- no evidence of metastatic disease.
Exclusion Criteria:
- history of severe hypersensitivity reaction to Taxotere;
- previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;
- treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 1
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825 mg/m2 po nabídce ve dnech 1-14 každého 3týdenního cyklu
75 mg/m2 iv v den 1 každého 3týdenního cyklu
100mg/m2 iv on day 1 of each 3 week cycle
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Aktivní komparátor: 2
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75 mg/m2 iv v den 1 každého 3týdenního cyklu
100mg/m2 iv on day 1 of each 3 week cycle
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Disease Free Survival [Number of Events]
Časové okno: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
|
Number of patients with/without recurrence of breast cancer, or death due to any cause.
|
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
|
|
Disease Free Survival [Time to Event]
Časové okno: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
|
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause).
Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
|
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Survival [Number of Events]
Časové okno: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
|
Number of patients who died/were alive.
|
Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
|
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Overall Survival [Time to Event]
Časové okno: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
|
Overall survival was measured as the time from the date of randomization to the date of death.
Patients still alive at the time of the analysis were censored using the date they were last known to be alive.
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Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
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Breast Cancer Free Survival [Number of Events]
Časové okno: Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .
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Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer.
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Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .
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Breast Cancer Free Survival [Time to Event]
Časové okno: Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
|
Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer.
Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
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Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
|
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Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]
Časové okno: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
|
Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.
|
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
|
|
Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event
Časové okno: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
|
Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause).
Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
|
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
|
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Disease Free Survival Including Any New Cancer as Event [Number of Events]
Časové okno: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
|
Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.
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Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
|
|
Disease Free Survival Including Any New Cancer as Event [Time to Event]
Časové okno: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
|
Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause).
Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
|
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. srpna 2002
Primární dokončení (Aktuální)
1. června 2010
Dokončení studie (Aktuální)
1. května 2012
Termíny zápisu do studia
První předloženo
5. srpna 2004
První předloženo, které splnilo kritéria kontroly kvality
5. srpna 2004
První zveřejněno (Odhad)
6. srpna 2004
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
21. prosince 2012
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
19. prosince 2012
Naposledy ověřeno
1. prosince 2012
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NO17629
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .