- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01160094
Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO) (TYCO)
25. mars 2016 oppdatert av: Novartis
Clinical Outcomes on ErbB2+ MBC Patients Treated With Lapatinib-Capecitabine After Trastuzumab Progression: Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO)
It will be conducted as an international multicenter prospective observational cohort study in a population of ErbB2 positive metastatic breast cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine immediately after 1st Trastuzumab progression (second line treatment), and Group 2: patients receiving Lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab progression (third line or greater).
Studieoversikt
Detaljert beskrivelse
Lapatinib in combination with capecitabine is a standard of care treatment for ErbB2+ metastatic breast cancer (MBC) patients who have progressed after anthracyclines, taxanes and trastuzumab treatment.
Results from the lapatinib pivotal trial showed that the addition of lapatinib to capecitabine increased median time to progression (TTP) even among heavily pre-treated patients (median of 4 prior lines of therapy).
A recent ad hoc subset analysis of this trial suggested that earlier administration of lapatinib-capecitabine in MBC patients who progress after trastuzumab may produce better clinical outcomes.
The TYCO study was designed to evaluate if early switch to lapatinib-capecitabine in patients with ErbB2+ MBC who have progressed on trastuzumab-containing regimen improves TTP in comparison with a later start (after several lines of therapy).
Secondary objectives include Overall Response Rate (ORR), 1 year Overall Survival (OS), and description of reported serious adverse events.
This is an international, multicenter, prospective, observational (non-interventional) study in 269 ErbB2+MBC patients whose disease has progressed after treatment with trastuzumab.
Two cohorts will be compared; Group 1: patients receiving lapatinib-capecitabine immediately after first trastuzumab progression, and Group 2: patients receiving lapatinib-capecitabine after two or more lines of treatment after first trastuzumab progression.
Eligibility criteria include females aged 18 or more with confirmed ErbB2+ MBC who have progressed after a previous trastuzumab-containing regimen, eligible to start standard therapy with lapatinib-capecitabine at approved conventional doses, as per local label approval.
The study duration is of 12 months with data collection at baseline and approximately every 3 months thereafter.
Patient evaluations will be conducted per standard patient care in each center and TTP will be determined by the treating physician (clinically or radiologically).
Enrollment started in February 2010 and completion of accrual is estimated for December 2011.
Studietype
Observasjonsmessig
Registrering (Faktiske)
288
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Bogota, Colombia
- Novartis Investigative Site
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Bogotá, Colombia
- Novartis Investigative Site
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Bucaramanga, Colombia
- Novartis Investigative Site
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Medellin, Colombia
- Novartis Investigative Site
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Pasto, Colombia
- Novartis Investigative Site
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Pereira, Colombia
- Novartis Investigative Site
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Dammam, Saudi-Arabia, Dammam 31444
- Novartis Investigative Site
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Jeddah, Saudi-Arabia, 21499
- Novartis Investigative Site
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Jeddah, Saudi-Arabia, jEDDAH 21423
- Novartis Investigative Site
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Jeddah, Saudi-Arabia
- Novartis Investigative Site
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Riyadh, Saudi-Arabia
- Novartis Investigative Site
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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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
All cases of ErbB2 positive metastatic breast cancer, receiving approved standard treatment with lapatinib-capecitabine, after trastuzumab-containing regimen progression in community setting.
Patients from private and public settings.
Beskrivelse
- Women with ErbB2+ MBC (ErbB2 expression confirmed by immunohistochemistry or FISH/CISH, either in the primary tumor or in the metastasis, according to the institution's common practice);
- Older than 18 years old;
- Have received prior treatment with trastuzumab-containing regimen for ErbB2+ breast cancer;
- Progressing after trastuzumab-containing regimen either used for the treatment of metastatic disease or progressing after adjuvant /neoadjuvant trastuzumab treatment;
- Eligible to start standard treatment with Lapatinib-capecitabine at conventional doses, OR receiving standard treatment with
- Lapatinib-capecitabine at conventional doses, for no longer than 10 weeks from the start of the treatment to the date of inclusion in the study;
- Signed consent to participate and release information for this study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Patients
ErbB2+ metastatic breast cancer patients
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patients treated with Lapatinib-Capecitabine after Trastuzumab Progression
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Time to disease progression
Tidsramme: One year
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the time from the date of start of Lapatinib capecitabine treatment until date of documented disease progression by the treating physician
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One year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Overall Response Rate
Tidsramme: One year
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the percentage of patients showing complete response (CR) and partial response (PR) to the given treatment.
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One year
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Overall survival
Tidsramme: measured at the end of follow-up
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the time from the start of lapatinib capecitabine treatment until death due to any cause
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measured at the end of follow-up
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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. februar 2010
Primær fullføring (Faktiske)
1. juli 2013
Studiet fullført (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først innsendt
8. juli 2010
Først innsendt som oppfylte QC-kriteriene
8. juli 2010
Først lagt ut (Anslag)
12. juli 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
28. mars 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. mars 2016
Sist bekreftet
1. mars 2016
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 113780
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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