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An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer

5 december 2013 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

50

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • België
      • Brussel, België
        • 1200.10.3208 Boehringer Ingelheim Investigational Site
      • Bruxelles, België
        • 1200.10.3201 Boehringer Ingelheim Investigational Site
      • Charleroi, België
        • 1200.10.3203 Boehringer Ingelheim Investigational Site
      • Gent, België
        • 1200.10.3205 Boehringer Ingelheim Investigational Site
      • Leuven, België
        • 1200.10.3204 Boehringer Ingelheim Investigational Site
      • Wilrijk, België
        • 1200.10.3206 Boehringer Ingelheim Investigational Site
  • Duitsland
      • Berlin, Duitsland
        • 1200.10.49005 Boehringer Ingelheim Investigational Site
      • Düsseldorf, Duitsland
        • 1200.10.49007 Boehringer Ingelheim Investigational Site
      • Erlangen, Duitsland
        • 1200.10.49008 Boehringer Ingelheim Investigational Site
      • Essen, Duitsland
        • 1200.10.49010 Boehringer Ingelheim Investigational Site
      • Kiel, Duitsland
        • 1200.10.49003 Boehringer Ingelheim Investigational Site
      • Mainz, Duitsland
        • 1200.10.49004 Boehringer Ingelheim Investigational Site
      • München, Duitsland
        • 1200.10.49001 Boehringer Ingelheim Investigational Site
      • Wiesbaden, Duitsland
        • 1200.10.49006 Boehringer Ingelheim Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: BIBW 2992
high dose once daily
Geneesmiddel: BIBW 2992
high dose once daily

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Response (OR)
Tijdsspanne: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Clinical Benefit (CB)
Tijdsspanne: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinical Benefit (CB)
Tijdsspanne: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Time to OR
Tijdsspanne: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Duration of OR
Tijdsspanne: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Progression-free Survival (PFS)
Tijdsspanne: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
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.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Overall Survival (OS)
Tijdsspanne: From randomisation to end of follow-up.
OS is defined as time from randomisation to death.
From randomisation to end of follow-up.
Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)
Tijdsspanne: Baseline and last assessment
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.
Baseline and last assessment
Best Change From Baseline in ECOG Performance Status
Tijdsspanne: baseline till end of treatment
Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead).
baseline till end of treatment
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)
Tijdsspanne: day 29
Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.
day 29

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Boehringer Ingelheim

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2006

Primaire voltooiing (Werkelijk)

1 mei 2009

Studieregistratiedata

Eerst ingediend

22 januari 2007

Eerst ingediend dat voldeed aan de QC-criteria

22 januari 2007

Eerst geplaatst (Schatting)

23 januari 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

31 december 2013

Laatste update ingediend die voldeed aan QC-criteria

5 december 2013

Laatst geverifieerd

1 augustus 2013

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1200.10
  • 2006-002018-36 (EudraCT-nummer: EudraCT)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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