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LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures

15. března 2019 aktualizováno: Boehringer Ingelheim

LUX-Breast 2; An Open Label, Phase II Trial of Afatinib (BIBW 2992) in Patients With Metastatic HER2-overexpressing Breast Cancer Failing HER2-targeted Treatment in the Neoadjuvant and/or Adjuvant Treatment Setting

The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW 2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant or adjuvant setting

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

74

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

  • Hongkong
      • Hong Kong, Hongkong
        • Queen Mary Hospital
      • Shatin, Hongkong
        • Prince of Wales Hospital
  • Indie
      • Amravati, Indie, 444606
        • Sujan Surgical Cancer Hospital
      • Maharashtra, Indie, 422 004
        • Curie Manavata Cancer Centre
      • Maharashtra, Indie, 400 012
        • Tata Memorial Hospital
      • Nagpur, Indie, 440010
        • Central India Cancer Research Institute
      • Pune, Indie, 411001
        • Ruby Hall Clinic
      • Thiruvananthapuram, Indie, 695 011
        • Regional Cancer Center
  • Polsko
      • Gdansk, Polsko, 80-211
        • University Clinical Center, Gdansk
  • Ruská Federace
      • Kazan, Ruská Federace, 420029
        • St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
      • Krasnodar, Ruská Federace, 350040
        • Clinical Oncology Dispensary No. 1, Dept. Chemotherapy
      • Moscow, Ruská Federace, 129128
        • N.A. Semashko Central Clinical Hospital, Moscow
      • Pyatigorsk, Ruská Federace, 357502
        • SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary"
      • Samara, Ruská Federace, 443 031
        • SBIH "Samara Regional Clinical Oncol. Dispensary", Samara
      • Sochi, Ruská Federace, 354057
        • GUZ "Oncological Dispesary #2"
      • Stavropol, Ruská Federace, 355 047
        • Stavropol Regional Clin. Oncology Dispensary Dept. Oncology
      • Yaroslavl, Ruská Federace, 150 040
        • Yaroslavl Regional Clinical Oncology Hosp. Dept.Chemotherapy
  • Spojené království
      • Barnstaple, Spojené království, EX31 4JB
        • North Devon District Hospital
      • Bournemouth, Spojené království, BH7 7DW
        • Royal Bournemouth and Christchurch Hospital
      • Exeter, Spojené království, EX2 5DW
        • Royal Devon and Exeter Hospital
      • London, Spojené království, W6 8RF
        • Charing Cross Hospital
  • Tchaj-wan
      • Taichung, Tchaj-wan, 404
        • China Medical University Hospital
      • Taichung, Tchaj-wan, 40705
        • Taichung Veterans General Hospital
      • Taipei, Tchaj-wan, 100
        • National Taiwan University Hospital
      • Taipei, Tchaj-wan, 10449
        • MacKay Memorial Hospital
      • Taipei, Tchaj-wan, 112
        • Taipe Veterans General Hospital
      • Taipei, Tchaj-wan, 112
        • Koo Foundation Sun Yet-Sen Cancer Center

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. Stage IV metastatic disease
  3. At least one measurable lesion according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1). Skin, bone and brain lesions are considered non-target lesions
  4. Must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and lapatinib treatment in the neoadjuvant and/or adjuvant setting

Exclusion criteria:

  1. Prior first line therapy for metastatic breast cancer
  2. Known pre-existing interstitial lung disease
  3. Active brain metastases
  4. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to trial treatment.
  5. Cardiac left ventricular function with resting ejection fraction of less than 50%.
  6. Prior treatment with Epidermal Growth Factor Receptor (EGFR)/HER2-targeted small molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or adjuvant setting
  7. Prior treatment with paclitaxel in the past 12 months
  8. Must not have received prior vinorelbine treatment - Further exclusion criteria apply

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: Nerandomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Afatinib 40mg once daily (OD)
Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
Lék: Afatinib 40mg once daily (OD)
Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
Experimentální: Paclitaxel 80 mg/m2 weekly
Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
Lék: Paclitaxel 80 mg/m2 weekly
Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
Experimentální: Vinorelbine 25 mg/m2 weekly
Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy
Lék: Vinorelbine 25 mg/m2 weekly
Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1
Časové okno: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Objective response according to RECIST v1.1. Best overall response of confirmed complete response (CR) or confirmed partial response (PR) recorded since first administration of trial medication and until the earliest of disease progression, death or start of next treatment in each part separately. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of participants with OR along with exact 95% Confidence Interval by Clopper and Pearson is presented.
From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Best Overall Response According to RECIST v1.1 (With Confirmation)
Časové okno: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented. Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Best Overall Response According to RECIST v1.1 (Regardless of Confirmation)
Časové okno: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part (without clinical disease assessment) .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented. Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Progression Free Survival (PFS)
Časové okno: From drug start date in monotherapy to 1st disease progression and drug start date in combination therapy to 2nd disease progression
Progression Free Survival is defined as the time from the drug start date to the date of 1st disease progression or death for monotherapy and 2nd disease progression or death from the drug start date of the combination therapy for combination therapy'. Median is calculated from the Kaplan-Meier curve.
From drug start date in monotherapy to 1st disease progression and drug start date in combination therapy to 2nd disease progression
Duration of Objective Response According to RECIST v1.1
Časové okno: From the first objective response to the time of progression or death, up to 1562 days
Duration of objective response, defined as the time from first objective response to the time of progression or death. (regardless of confirmation). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
From the first objective response to the time of progression or death, up to 1562 days
Percentage of Patients With Highest Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade of 3 or Higher
Časové okno: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Percentage of patients with highest common terminology criteria for adverse events (CTCAE) version 3.0 Grade of 3 or higher.
From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP)
Časové okno: Baseline and End of treatment period, up to 1562 days
Change from baseline to end of treatment in systolic blood pressure (SBP).
Baseline and End of treatment period, up to 1562 days
Change From Baseline to End of Treatment in Diastolic Blood Pressure (DBP)
Časové okno: Baseline and End of treatment period, up to 1562 days
Change from baseline to end of treatment in diastolic blood pressure (DBP).
Baseline and End of treatment period, up to 1562 days
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values
Časové okno: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Number of patient with possibly clinically significant (PCS) laboratory values by functional group (haematology, differentials, coagulation, electrolytes, enzymes, and substrates). Acronyms Used: Prothrombin time-International normalized ratio (PT-INR), Alanine aminotransferase/Glutamic pyruvic transaminase (ALT/GPT) Serum glutamic pyruvic transaminase (SGPT), Aspartate aminotransferase/Glutamic-oxaloacetic transaminase (AST/GOT) Serum glutamic-oxaloacetic transaminase (SGOT)
From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 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 (Aktuální)

24. května 2011

Primární dokončení (Aktuální)

13. března 2017

Dokončení studie (Aktuální)

13. března 2017

Termíny zápisu do studia

První předloženo

6. ledna 2011

První předloženo, které splnilo kritéria kontroly kvality

6. ledna 2011

První zveřejněno (Odhad)

7. ledna 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. června 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. března 2019

Naposledy ověřeno

1. března 2019

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 1200.98
  • 2010-021945-29 (Číslo EudraCT)

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