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)
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.
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Kontakte und Standorte
Studienorte
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Athens, Griechenland, GR11528
- Athens
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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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
Zeitfenster: 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
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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
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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
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Studienleiter: Kiki Karvounis, GenesisPharma Medical Department
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- NIPMS-GENESIS-ONCO-GRC-001
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