- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02626013
Real-world Evidence Prospective Study on the Effect of Nab-paclitaxel Treatment on the Clinical Outcomes and HRQoL in Patients With MBC in Greece (ABReast)
26. november 2020 oppdatert av: Genesis Pharma S.A.
A Multicenter, Prospective Cohort Study to Provide Real-world Evidence on the Effect of Nab-paclitaxel (ABRAXANE®) Treatment on the Clinical Outcomes and Health-related Quality of Life in Patients With Metastatic Breast Cancer in Greece. The 'ABReast' Study.
This non-interventional study aims at assessing the impact of nab-paclitaxel on the clinical outcomes and the health-related QoL (HRQoL) of this heavily burdened and difficult-to-treat population.
Notably, the data generated in the context of this study will serve as complementary evidence to that of the tightly and strictly controlled pre-registration clinical trial setting, which is of essential importance especially in patient populations with diseases of complex and heterogeneous biology, such as breast cancer.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
156
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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-
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Athens, Hellas, GR11528
- Athens
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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
Sannsynlighetsprøve
Studiepopulasjon
Adult patients with a histologically or cytologically confirmed diagnosis of MBC who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated
Beskrivelse
Inclusion Criteria:
Patients eligible for inclusion in this study have to meet all of the following criteria:
- Adult patients (18 years and older);
- Patients with a histologically or cytologically confirmed diagnosis of MBC who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated;
- Patients for whom the decision to prescribe therapy with nab-paclitaxel according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study; the assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of nab-paclitaxel is clearly separated from the physician's decision to include the patient in the current study;
- Patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;
- Patients must have signed an informed consent document;
- Patients must be able to read, understand and complete the study specific questionnaire
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from participation in this study:
- Patients who have initiated treatment with nab-paclitaxel more than 7 days prior to their enrolment into the study;
- Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC;
- Receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with nab-paclitaxel.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluation of the best objective response to nab-paclitaxel treatment in eligible MBC patients as measured from the start of therapy until disease progression, unacceptable toxicity, or termination of study participation
Tidsramme: as measured by routine assessments from the start of nab-paclitaxel therapy (at least 6 months post-treatment onset and up to 12 months) until disease progression, occurrence of unacceptable toxicity, or study participation termination
|
The proportion of objective responders [patients with either a complete response (CR) or a partial response (PR) as the best objective response] as measured by routine assessments from the start of nab-paclitaxel therapy until disease progression, occurrence of unacceptable toxicity, or study participation termination whichever occurs sooner
|
as measured by routine assessments from the start of nab-paclitaxel therapy (at least 6 months post-treatment onset and up to 12 months) until disease progression, occurrence of unacceptable toxicity, or study participation termination
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Kiki Karvounis, GenesisPharma Medical Department
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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 (Faktiske)
12. april 2016
Primær fullføring (Faktiske)
12. september 2018
Studiet fullført (Faktiske)
12. september 2018
Datoer for studieregistrering
Først innsendt
25. november 2015
Først innsendt som oppfylte QC-kriteriene
7. desember 2015
Først lagt ut (Anslag)
10. desember 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. november 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. november 2020
Sist bekreftet
1. november 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NIPMS-GENESIS-ONCO-GRC-001
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. .