- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01325428
Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
17. Juni 2016 aktualisiert von: Boehringer Ingelheim
An Open Label, Phase II Trial of Afatinib With or Without Vinorelbine for the Treatment of HER2-overexpressing Inflammatory Breast Cancer
The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer.
The study will include patients who have and have not failed prior trastuzumab treatment.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
26
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Victoria
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East Bentleigh, Victoria, Australien
- 1200.89.61002 Boehringer Ingelheim Investigational Site
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Western Australia
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Perth, Western Australia, Australien
- 1200.89.61003 Boehringer Ingelheim Investigational Site
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Hong Kong, Hongkong
- 1200.89.85201 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republik von
- 1200.89.82001 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republik von
- 1200.89.82002 Boehringer Ingelheim Investigational Site
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Bangkok, Thailand
- 1200.89.66002 Boehringer Ingelheim Investigational Site
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Bangkok, Thailand
- 1200.89.66004 Boehringer Ingelheim Investigational Site
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Chiangmai, Thailand
- 1200.89.66003 Boehringer Ingelheim Investigational Site
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Hat-Yai, Songkhla, Thailand
- 1200.89.66001 Boehringer Ingelheim Investigational Site
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Ariana, Tunesien
- 1200.89.21601 Boehringer Ingelheim Investigational Site
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Sousse, Tunesien
- 1200.89.21602 Boehringer Ingelheim Investigational Site
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California
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Los Angeles, California, Vereinigte Staaten
- 1200.89.10001 Boehringer Ingelheim Investigational Site
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North Carolina
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Durham, North Carolina, Vereinigte Staaten
- 1200.89.10005 Boehringer Ingelheim Investigational Site
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Bournemouth, Vereinigtes Königreich
- 1200.89.44002 Boehringer Ingelheim Investigational Site
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London, Vereinigtes Königreich
- 1200.89.44001 Boehringer Ingelheim Investigational Site
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London, Vereinigtes Königreich
- 1200.89.44003 Boehringer Ingelheim Investigational Site
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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 und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
Inclusion criteria:
- Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
- Locally advanced or metastatic disease
- Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)
- For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment
- Investigator-confirmed diagnosis of Inflammatory Breast Cancer
- Must have biopsiable disease
Exclusion criteria:
- Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population)
- Must not have received prior vinorelbine treatment
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Afatinib once daily (OD)
Patients receive afatinib monotherapy once daily until progression of their disease
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Patient to receive afatinib monotherapy until progression of their disease
Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Zeitfenster: This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
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Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
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This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
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Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Zeitfenster: This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
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Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
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This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Zeitfenster: This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
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Objective response was defined on a patient level as a best response of CR or PR.
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This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
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Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Zeitfenster: This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.
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Objective response was defined on a patient level as a best response of CR or PR.
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This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.
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Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Zeitfenster: This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
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Objective response was defined on a patient level as a best response of CR or PR.
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This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
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Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).
Zeitfenster: This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
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Objective response was defined on a patient level as a best response of CR or PR.
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This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
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Part A: Duration of Unconfirmed Objective Response.
Zeitfenster: From first drug administration until end of Part A, up to 929 days.
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Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR).
Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)).
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From first drug administration until end of Part A, up to 929 days.
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Part B: Duration of Unconfirmed Objective Response.
Zeitfenster: From first drug administration until end of Part B, up to 929 days.
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Objective response was defined on a patient level as a best response of CR or PR.
Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS).
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From first drug administration until end of Part B, up to 929 days.
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Part A: Progression Free Survival.
Zeitfenster: From first drug administration until end of Part A, up to 713 days.
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PD was evaluated according to the RECIST version 1.1.
For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1.
The date of progression and date of first administration referred to the respective part of the study A.
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From first drug administration until end of Part A, up to 713 days.
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Part B: Progression Free Survival.
Zeitfenster: From first drug administration until end of Part B, up to 230 days.
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PD was evaluated according to the RECIST version 1.1.
For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1.
The date of progression and date of first administration referred to the respective part of the study B.
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From first drug administration until end of Part B, up to 230 days.
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Progression Free Survival Over the Whole Sudy.
Zeitfenster: From first drug administration until end of study, up to 700 days.
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PD was evaluated according to the RECIST version 1.1.
Number of days from the start of monotherapy to the date of second PD.
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From first drug administration until end of study, up to 700 days.
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
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
1. August 2011
Primärer Abschluss (Tatsächlich)
1. November 2014
Studienabschluss (Tatsächlich)
1. November 2014
Studienanmeldedaten
Zuerst eingereicht
28. März 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. März 2011
Zuerst gepostet (Schätzen)
29. März 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
19. Juli 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
17. Juni 2016
Zuletzt verifiziert
1. Juni 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Hautkrankheiten
- Neubildungen
- Neubildungen nach Standort
- Brusterkrankungen
- Neoplasien der Brust
- Entzündliche Neoplasmen der Brust
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Tubulin-Modulatoren
- Antimitotische Mittel
- Mitose-Modulatoren
- Antineoplastische Mittel, Phytogen
- Proteinkinase-Inhibitoren
- Vinorelbin
- Afatinib
Andere Studien-ID-Nummern
- 1200.89
- 2010-024454-10 (EudraCT-Nummer: EudraCT)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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