- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01160094
Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO) (TYCO)
25. marts 2016 opdateret af: 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).
Studieoversigt
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
288
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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 Arabien, Dammam 31444
- Novartis Investigative Site
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Jeddah, Saudi Arabien, 21499
- Novartis Investigative Site
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Jeddah, Saudi Arabien, jEDDAH 21423
- Novartis Investigative Site
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Jeddah, Saudi Arabien
- Novartis Investigative Site
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Riyadh, Saudi Arabien
- Novartis Investigative Site
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Patients
ErbB2+ metastatic breast cancer patients
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patients treated with Lapatinib-Capecitabine after Trastuzumab Progression
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. februar 2010
Primær færdiggørelse (Faktiske)
1. juli 2013
Studieafslutning (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først indsendt
8. juli 2010
Først indsendt, der opfyldte QC-kriterier
8. juli 2010
Først opslået (Skøn)
12. juli 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. marts 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. marts 2016
Sidst verificeret
1. marts 2016
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 113780
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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