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Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer

17. června 2016 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

26

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Austrálie
    • Victoria
      • East Bentleigh, Victoria, Austrálie
        • 1200.89.61002 Boehringer Ingelheim Investigational Site
    • Western Australia
      • Perth, Western Australia, Austrálie
        • 1200.89.61003 Boehringer Ingelheim Investigational Site
  • Hongkong
      • Hong Kong, Hongkong
        • 1200.89.85201 Boehringer Ingelheim Investigational Site
  • Korejská republika
      • Seoul, Korejská republika
        • 1200.89.82001 Boehringer Ingelheim Investigational Site
      • Seoul, Korejská republika
        • 1200.89.82002 Boehringer Ingelheim Investigational Site
  • Spojené království
      • Bournemouth, Spojené království
        • 1200.89.44002 Boehringer Ingelheim Investigational Site
      • London, Spojené království
        • 1200.89.44001 Boehringer Ingelheim Investigational Site
      • London, Spojené království
        • 1200.89.44003 Boehringer Ingelheim Investigational Site
  • Spojené státy
    • California
      • Los Angeles, California, Spojené státy
        • 1200.89.10001 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Durham, North Carolina, Spojené státy
        • 1200.89.10005 Boehringer Ingelheim Investigational Site
  • Thajsko
      • Bangkok, Thajsko
        • 1200.89.66002 Boehringer Ingelheim Investigational Site
      • Bangkok, Thajsko
        • 1200.89.66004 Boehringer Ingelheim Investigational Site
      • Chiangmai, Thajsko
        • 1200.89.66003 Boehringer Ingelheim Investigational Site
      • Hat-Yai, Songkhla, Thajsko
        • 1200.89.66001 Boehringer Ingelheim Investigational Site
  • Tunisko
      • Ariana, Tunisko
        • 1200.89.21601 Boehringer Ingelheim Investigational Site
      • Sousse, Tunisko
        • 1200.89.21602 Boehringer Ingelheim Investigational Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion criteria:

  1. Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
  2. Locally advanced or metastatic disease
  3. Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)
  4. For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment
  5. Investigator-confirmed diagnosis of Inflammatory Breast Cancer
  6. Must have biopsiable disease

Exclusion criteria:

  1. Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population)
  2. Must not have received prior vinorelbine treatment

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Afatinib once daily (OD)
Patients receive afatinib monotherapy once daily until progression of their disease
Lék: Afatinib once daily (OD)
Patient to receive afatinib monotherapy until progression of their disease
Lék: Vinorelbine Weekly
Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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).
Časové okno: 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.
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).
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.
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).
Časové okno: 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.
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).
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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Časové okno: 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.
Objective response was defined on a patient level as a best response of CR or PR.
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.
Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Časové okno: 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.
Objective response was defined on a patient level as a best response of CR or PR.
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.
Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Časové okno: 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.
Objective response was defined on a patient level as a best response of CR or PR.
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.
Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).
Časové okno: 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.
Objective response was defined on a patient level as a best response of CR or PR.
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.
Part A: Duration of Unconfirmed Objective Response.
Časové okno: From first drug administration until end of Part A, up to 929 days.
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)).
From first drug administration until end of Part A, up to 929 days.
Part B: Duration of Unconfirmed Objective Response.
Časové okno: From first drug administration until end of Part B, up to 929 days.
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).
From first drug administration until end of Part B, up to 929 days.
Part A: Progression Free Survival.
Časové okno: From first drug administration until end of Part A, up to 713 days.
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.
From first drug administration until end of Part A, up to 713 days.
Part B: Progression Free Survival.
Časové okno: From first drug administration until end of Part B, up to 230 days.
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.
From first drug administration until end of Part B, up to 230 days.
Progression Free Survival Over the Whole Sudy.
Časové okno: From first drug administration until end of study, up to 700 days.
PD was evaluated according to the RECIST version 1.1. Number of days from the start of monotherapy to the date of second PD.
From first drug administration until end of study, up to 700 days.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Boehringer Ingelheim

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. srpna 2011

Primární dokončení (Aktuální)

1. listopadu 2014

Dokončení studie (Aktuální)

1. listopadu 2014

Termíny zápisu do studia

První předloženo

28. března 2011

První předloženo, které splnilo kritéria kontroly kvality

28. března 2011

První zveřejněno (Odhad)

29. března 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

19. července 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. června 2016

Naposledy ověřeno

1. června 2016

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 1200.89
  • 2010-024454-10 (Číslo EudraCT: EudraCT)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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