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Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine (KNOWHER)

4. März 2020 aktualisiert von: BELEN RUIZ-ANTORAN

Use Of Pertuzumab And Trastuzumab Emtansine In Adult Patients With Her2-Positive Metastatic Or Locally Recurrent Unresectable Breast Cancer

The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

This is a retrospective, non-interventional, non-comparative, observational cohort study / registry in the Spain. The study design will reflect real-life clinical management of patients with HER2-positive MBC. Type and frequency of actual patient visits and all evaluations will be done as for routine clinical practice.

The analysis of the efficacy and safety results obtained in patients receiving pertuzumab or TDM1 in those early access systems is of utmost importance. These real-world patients with advanced breast cancer may have different characteristics than those enrolled in clinical trials and clinicians must often extrapolate into therapeutic decisions not fully supported by a robust evidence.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

220

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Spanien
      • Madrid, Spanien, 28222
        • Puerta de Hierro University Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 100 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

This study will include a cohort of approximately 700 adult patients from the Spain with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab under compassionate use or early access program. The decision to initiate use of Trastuzumab emtansine (T-DM1) and Pertuzumab is made independently by the participant and their health care provider and is not mandated by the study design or protocol.

Beschreibung

Inclusion Criteria:

  • Adult patients (age ≥ 18 years at enrolment) with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab.
  • Patients who initiate Trastuzumab emtansine (T-DM1) and Pertuzumab under Spanish compassionate use or early access program.

Exclusion Criteria:

  • Given the characteristics of the study there are no exclusion criteria.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Pertuzumab
Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Pertuzumab under Spanish compassionate use or early access program
Trastuzumab emtansine
Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) under Spanish compassionate use or early access program

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall survival.
Zeitfenster: Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).
The time between the date of start of treatment and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive
Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression free survival.
Zeitfenster: Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)
The time from start of treatment to the date of the first documented tumour progression as determined by the clinician (may be based on clinical examination or radiographic or laboratory features).
Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)
Best overall response rate
Zeitfenster: Through study completion, an average of 4 year
Response rate is defined as the proportion of patients with complete response (CR) or partial response (PR) based on their best overall response as written in the medical record
Through study completion, an average of 4 year
Duration of response (DOR)
Zeitfenster: Through study completion, an average of 4 year
The time between the date of first confirmed response to the date of the first documented tumour progression, or death due to any cause, whichever occurs first. At the time of the analysis, several limitations should be taken into consideration for this retrospective study: DOR is only appraisable if measurable disease and DOR data availability in the medical records (ideally assessed with the RECIST criteria) could be incomplete.
Through study completion, an average of 4 year
Time to treatment failure
Zeitfenster: Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)
Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)
Time to Objective Response
Zeitfenster: Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)
The time from start of treatment to the date of the first confirmed response (evaluated for responders only)
Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)
Time to change treatment
Zeitfenster: Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)
Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)
Time to next treatment
Zeitfenster: Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)
Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)
All suspected Grade 3/4/5 adverse reactions
Zeitfenster: Through study completion, an average of 4 year
Through study completion, an average of 4 year
Adverse events of special interest to anti HER2 Mab (AESI)
Zeitfenster: Through study completion, an average of 4 year
  • AESIs regarding treatment with T-DM1: Hepatic disorder (specific analytical alteration)
  • AESIs regarding treatment with Pertuzumab: Interstitial Lung Disease
Through study completion, an average of 4 year
AEs of scientific interest
Zeitfenster: Through study completion, an average of 4 year
  • An asymptomatic decline in LVEF requiring treatment or leading to discontinuation of study treatment (regarding treatment with T-DM1 and Pertuzumab)
  • Other AEs leading to treatment discontinuation
Through study completion, an average of 4 year

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

BELEN RUIZ-ANTORAN

Ermittler

  • Hauptermittler: Belén Ruiz-Antorán, PhD, Department of Clinical Pharmacology, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Dezember 2017

Primärer Abschluss (Tatsächlich)

1. Oktober 2018

Studienabschluss (Tatsächlich)

31. Januar 2020

Studienanmeldedaten

Zuerst eingereicht

11. Januar 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Januar 2017

Zuerst gepostet (Schätzen)

19. Januar 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. März 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. März 2020

Zuletzt verifiziert

1. März 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ML29844

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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