An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer
5 dicembre 2013 aggiornato da: Boehringer Ingelheim
An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen
The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
50
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Brussel, Belgio
- 1200.10.3208 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgio
- 1200.10.3201 Boehringer Ingelheim Investigational Site
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Charleroi, Belgio
- 1200.10.3203 Boehringer Ingelheim Investigational Site
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Gent, Belgio
- 1200.10.3205 Boehringer Ingelheim Investigational Site
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Leuven, Belgio
- 1200.10.3204 Boehringer Ingelheim Investigational Site
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Wilrijk, Belgio
- 1200.10.3206 Boehringer Ingelheim Investigational Site
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Berlin, Germania
- 1200.10.49005 Boehringer Ingelheim Investigational Site
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Düsseldorf, Germania
- 1200.10.49007 Boehringer Ingelheim Investigational Site
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Erlangen, Germania
- 1200.10.49008 Boehringer Ingelheim Investigational Site
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Essen, Germania
- 1200.10.49010 Boehringer Ingelheim Investigational Site
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Kiel, Germania
- 1200.10.49003 Boehringer Ingelheim Investigational Site
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Mainz, Germania
- 1200.10.49004 Boehringer Ingelheim Investigational Site
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München, Germania
- 1200.10.49001 Boehringer Ingelheim Investigational Site
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Wiesbaden, Germania
- 1200.10.49006 Boehringer Ingelheim Investigational Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
Inclusion criteria:
Inclusion Criteria:
- Female patients age 18 years or older
- Histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage IV);
- HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative)
- At least one measurable tumour lesion (RECIST);
- Availability of tumour samples
- Written informed consent that is consistent with ICH-GCP guidelines and local law
- Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 - 2.
Exclusion criteria:
Exclusion Criteria:
- Active infectious disease
- Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea
- Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol
- Active/symptomatic brain metastases
- Cardiac left ventricular function with resting ejection fraction < 50% (below upper limit of normal)
- ANC less than 1500/mm3 platelet count less than 100 000/mm3
- Bilirubin greater than 1.5 mg /dl (>26 and#61549 mol /L, SI unit equivalent)
- AST and ALT greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases
- Serum creatinine greater than 1.5 mg/dl (>132 and#61549 mol/L, SI unit equivalent)
- Patients who are sexually active and unwilling to use a medically acceptable method of contraception
- Pregnancy or breast-feeding
- Concomitant treatment with other investigational drugs or other anti-cancer-therapy during this study and/or during the past two/four weeks, prior to the first treatment with the trial drug. Concurrent treatment with biphosphonates is allowed
- Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors patients unable to comply with the protocol
- Active alcohol or drug abuse
- Other malignancy within the past 5 years
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: BIBW 2992
high dose once daily
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high dose once daily
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Objective Response (OR)
Lasso di tempo: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST).
OR was primary endpoint only for Cohort B.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Clinical Benefit (CB)
Lasso di tempo: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria.
CB was primary endpoint only for Cohort A.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Clinical Benefit (CB)
Lasso di tempo: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria.
CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Time to OR
Lasso di tempo: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Duration of OR
Lasso di tempo: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Progression-free Survival (PFS)
Lasso di tempo: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first.
It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment.
Median time results from unstratified Kaplan-Meier estimates.
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Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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Overall Survival (OS)
Lasso di tempo: From randomisation to end of follow-up.
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OS is defined as time from randomisation to death.
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From randomisation to end of follow-up.
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Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)
Lasso di tempo: Baseline and last assessment
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LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan.
MUGA scan is an useful noninvasive tool for assessing the function of the heart.
Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.
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Baseline and last assessment
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Best Change From Baseline in ECOG Performance Status
Lasso di tempo: baseline till end of treatment
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Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status.
ECOG is measured as score between 0 (fully active) and 5 (dead).
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baseline till end of treatment
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Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)
Lasso di tempo: day 29
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Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.
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day 29
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
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Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2006
Completamento primario (Effettivo)
1 maggio 2009
Date di iscrizione allo studio
Primo inviato
22 gennaio 2007
Primo inviato che soddisfa i criteri di controllo qualità
22 gennaio 2007
Primo Inserito (Stima)
23 gennaio 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
31 dicembre 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
5 dicembre 2013
Ultimo verificato
1 agosto 2013
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1200.10
- 2006-002018-36 (Numero EudraCT: EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .