A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
19. december 2012 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
2611
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77060
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
|
825mg/m2 po bud på dag 1-14 i hver 3 ugers cyklus
75 mg/m2 iv på dag 1 i hver 3-ugers cyklus
100mg/m2 iv on day 1 of each 3 week cycle
|
|
Aktiv komparator: 2
|
75 mg/m2 iv på dag 1 i hver 3-ugers cyklus
100mg/m2 iv on day 1 of each 3 week cycle
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2002
Primær færdiggørelse (Faktiske)
1. juni 2010
Studieafslutning (Faktiske)
1. maj 2012
Datoer for studieregistrering
Først indsendt
5. august 2004
Først indsendt, der opfyldte QC-kriterier
5. august 2004
Først opslået (Skøn)
6. august 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. december 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. december 2012
Sidst verificeret
1. december 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NO17629
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