Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice (AMBER)

28. oktober 2016 oppdatert av: Celgene Corporation

Retrospective Observational Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice

This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. The study will be conducted by reviewing the medical records of patients up to the start of the study. In each case, only data from before the start of the study will be obtained in order to ensure they are retrospective in nature, thus reflecting the regular use of nab-paclitaxel in clinical practice and avoiding interference with the physician's clinical practice.

To ensure the observational nature of this study, these data will be collected whenever they are available in the patient's medical record, and so no diagnostic or therapeutic intervention outside regular clinical practice will be used.

Studieoversikt

Status

Avsluttet

Forhold

Detaljert beskrivelse

This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. Investigators will include all consecutive adult patients diagnosed with HER2-negative MBC who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease during the past 3 years (2012-2014). These patients must meet all the inclusion criteria and none of the exclusion criteria established in this protocol.

The primary objective is to describe the effectiveness of nab-paclitaxel in terms of response in early lines of chemotherapy for metastatic breast cancer in routine clinical practice.

This study plans to collect data retrospectively, provided they are available in the patient's medical record and according to routine clinical practice.

Studietype

Observasjonsmessig

Registrering (Faktiske)

46

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
      • Madrid, Spania, 28040
        • Hospital Clínico San Carlos
      • Madrid, Spania, 28033
        • MD Anderson
      • Madrid, Spania, 28041
        • Hospital 12 Octubre
      • Madrid, Spania, 28007:
        • Hospital Gregorio Marañon
      • Madrid, Spania, 28223
        • Hospital Quirón
      • Murcia, Spania, 30008
        • Hospital Morales Meseguer
    • Andalucía
      • Jaén, Andalucía, Spania, 23007
        • Complejo Hospitalario Jaén
    • Aragón
      • Zaragoza, Aragón, Spania, 50009
        • Hospital Clinico Lozano Blesa
    • Castilla La Mancha
      • Toledo, Castilla La Mancha, Spania, 45071
        • Hospital Virgen Salud
    • Castilla y León
      • Burgos, Castilla y León, Spania, 09006
        • Hospital Universitario Burgos
      • Salamanca, Castilla y León, Spania, 37007
        • Hospital Clinico Salamanca
      • Valladolid, Castilla y León, Spania, 47005:
        • Hospital Clínico Valladolid
    • Cataluña
      • Barcelona, Cataluña, Spania, 08035
        • Hospital Vall D´Hebron
      • Reus, Cataluña, Spania, 43204
        • Hospital Universitario San Joan Reus
    • Extremadura
      • Badajoz, Extremadura, Spania, 06006
        • Hospital Infanta Cristina
      • Badajoz, Extremadura, Spania, 06011
        • Capio Clideba
    • Galicia
      • Orense, Galicia, Spania, 32005
        • Complejo Hospitalario Orense
    • Murcia
      • Cartagena, Murcia, Spania, 30202
        • Hospital Santa Lucía
    • Navarra
      • Pamplona, Navarra, Spania, 31008
        • Hospital Navarra

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

Adult patients diagnosed with HER2-negative MBC who have started treatment with nab-paclitaxel monotherapy no further than third-line chemotherapy for metastatic disease between 2012 and 2014 will be enrolled consecutively. In addition, patients must meet the selection criteria established in this protocol.

Beskrivelse

Inclusion Criteria:

  • Women ≥18 years of age.
  • Confirmed diagnosis of MBC (stage IV).
  • Breast adenocarcinoma confirmed histologically.
  • HER2-negative according to the American Society of Clinical Oncology (ASCO) and Anatomical Pathology (CAP) criteria for the detection of HER2 in breast cancer.
  • Patients who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease in HER2-negative breast cancer during the period 2012-2014 (3 years) and who have received at least one cycle of treatment.
  • Ability to give informed consent, preferably in writing or orally in front of a witness, before the start of data collection (if it is able to be given).

Exclusion Criteria:

  • Patients with any medical or psychological disorder which in the investigator's opinion might compromise the ability of the patient to give their informed consent.
  • Patients who have received treatment with nab-paclitaxel combined with other chemotherapy agents or anti-angiogenic drugs or tumor-targeting drugs with anti-tumor activity.
  • Patients who have taken part in any clinical trial (interventional) during the study period.

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
Abraxane® treatment in patients with metastatic breast cancer
Patients diagnosed with HER2-negative MBC who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease during the past 3 years (2012-2014) and who give their consent to data collection.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall response rate (ORR)
Tidsramme: Up to approximately 8 months
The number of patients who achieve a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria during treatment with nab-paclitaxel until disease progression, the end of treatment or the start of the study, whichever comes first.
Up to approximately 8 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Response Rate (ORR)
Tidsramme: Up to approximately 8 months
The number of patients who achieve a complete response (CR) or partial response (PR) during the first 3 treatment cycles with nab-paclitaxel and the corresponding 95% CI will be calculated.
Up to approximately 8 months
Disease control rate (DCR)
Tidsramme: Up to approximately 8 months
The percentage of patients with complete response (CR), partial response (PR), or stable disease (SD) for at least 16 weeks, and the corresponding 95% confidence intervals (CI) will be calculated.
Up to approximately 8 months
Time to disease progression (TTP)
Tidsramme: Up to approximately 8 months
Is defined as the time from the start of treatment with nab-paclitaxel to disease progression or death due to progression. TTP will be estimated by using the Kaplan-Meier method. The median and confidence interval for the median at 95% reliability (95% CI) will be calculated. In patients who show no disease progression or who have not died, the date of censoring may be the day on which the patient's death is documented, the day of the last follow-up assessment or the day of the last tumor assessment in case the foregoing is not available.
Up to approximately 8 months
Progression-free survival (PFS)
Tidsramme: Up to approximately 8 months
Is defined as the time from the start of treatment with nab-paclitaxel to disease progression or death from any cause. PFS will be estimated by using the Kaplan-Meier method. Patients who have shown no disease progression or who have not died at the time of data collection will be censored on the date on which it was last known that no disease progression occurred. The date of censoring may be the day of the last follow-up assessment or the day of the last tumor assessment in case the foregoing is not available.
Up to approximately 8 months
Overall survival (OS)
Tidsramme: Up to approximately 8 months
Is defined as the time from the start of treatment with nab-paclitaxel to death from any cause. OS will be estimated by using the Kaplan-Meier method. Patients who have not died at the time of data collection will be censored on the date on which they are last known to be alive. The date of censoring may be the day of the last follow-up assessment or the day of the last tumor assessment in case the foregoing is not available.
Up to approximately 8 months
Adverse Events (AEs)
Tidsramme: Up to approximately 8 months
Number of participants with adverse events
Up to approximately 8 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Celgene Corporation

Etterforskere

  • Studieleder: Lorena Pellín, MD, Celgene Spain

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. januar 2016

Primær fullføring (Faktiske)

1. august 2016

Studiet fullført (Faktiske)

1. august 2016

Datoer for studieregistrering

Først innsendt

12. januar 2016

Først innsendt som oppfylte QC-kriteriene

12. januar 2016

Først lagt ut (Anslag)

13. januar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

1. november 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. oktober 2016

Sist bekreftet

1. oktober 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CEL-CMM-2015-01

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. .

Kliniske studier på Brystneoplasmer

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Rwanda

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere