A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
19. desember 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
2611
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Texas
-
Houston, Texas, Forente stater, 77060
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 1
|
825mg/m2 po bud på dag 1-14 i hver 3 ukers syklus
75 mg/m2 iv på dag 1 i hver 3 ukers syklus
100mg/m2 iv on day 1 of each 3 week cycle
|
|
Aktiv komparator: 2
|
75 mg/m2 iv på dag 1 i hver 3 ukers syklus
100mg/m2 iv on day 1 of each 3 week cycle
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Disease Free Survival [Number of Events]
Tidsramme: 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]
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival [Number of Events]
Tidsramme: 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.
|
|
Overall Survival [Time to Event]
Tidsramme: 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.
|
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.
|
|
Breast Cancer Free Survival [Number of Events]
Tidsramme: 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 .
|
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.
|
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 .
|
|
Breast Cancer Free Survival [Time to Event]
Tidsramme: 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.
|
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.
|
|
Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]
Tidsramme: 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
Tidsramme: 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.
|
|
Disease Free Survival Including Any New Cancer as Event [Number of Events]
Tidsramme: 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.
|
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]
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
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Sponsor
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2002
Primær fullføring (Faktiske)
1. juni 2010
Studiet fullført (Faktiske)
1. mai 2012
Datoer for studieregistrering
Først innsendt
5. august 2004
Først innsendt som oppfylte QC-kriteriene
5. august 2004
Først lagt ut (Anslag)
6. august 2004
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
21. desember 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. desember 2012
Sist bekreftet
1. desember 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NO17629
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
produkt produsert i og eksportert fra USA
Nei
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