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

28 oktober 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

46

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall response rate (ORR)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Response Rate (ORR)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Up to approximately 8 months
Number of participants with adverse events
Up to approximately 8 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Celgene Corporation

Onderzoekers

  • Studie directeur: Lorena Pellín, MD, Celgene Spain

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2016

Primaire voltooiing (Werkelijk)

1 augustus 2016

Studie voltooiing (Werkelijk)

1 augustus 2016

Studieregistratiedata

Eerst ingediend

12 januari 2016

Eerst ingediend dat voldeed aan de QC-criteria

12 januari 2016

Eerst geplaatst (Schatting)

13 januari 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

1 november 2016

Laatste update ingediend die voldeed aan QC-criteria

28 oktober 2016

Laatst geverifieerd

1 oktober 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CEL-CMM-2015-01

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