LUX-Breast 1; An Open Label, Randomised Phase III Trial of BIBW 2992 and Vinorelbine Versus Trastuzumab and Vinorelbine in Patients With Metastatic HER2-overexpressing Breast Cancer Failing One Prior Trastuzumab Treatment

CompletadoFase 3ClinicalTrials.gov

ID: NCT01125566Tipo: INTERVENTIONALInicio: 22 de jun de 2010Fin estimado: 6 de jul de 2018

Traducción no disponible, mostrando original

Resumen

To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Histologically confirmed diagnosis of HER2-overexpression breast cancer
Stage IV metastatic disease
Must have progressed on one prior trastuzumab treatment
no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)
Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
Must have (archived) tumour tissue sample available for central re-assessment of HER2-status
At least one measurable lesion according to RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 .

Criterios de exclusión

Prior treatment with Epidermal Growth Factor Receptor/Human Epidermal Growth Factor Receptor(EGFR/HER2)-targeted small molecules or antibodies other than trastuzumab
Prior treatment with vinorelbine
Known pre-existing interstitial lung disease
Active brain metastases
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 randomisation.
Cardiac left ventricular function with resting ejection fraction of less than 50%.
Patients unable to comply with the protocol.
Any contraindications for therapy with vinorelbine or trastuzumab.
Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.
Use of any investigational drug within 4 weeks of randomisation.
Inadequate hepatic, renal and haematologic organ function

Intervenciones

drug

BIBW 2992

patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management

drug

trastuzumab

patients receive trastuzumab 2mg/kg intravenously every week

drug

vinorelbine

patients receive vinorelbine 25mg/m² intravenously every week

drug

vinorelbine

patients receive vinorelbine 25mg/m² intravenously every week

Ubicaciones

Instituto Medico de Asistencia e Investigaciones S. A.

Buenos Aires, Argentina

Hospital Britanico

Capital Federal, Argentina

Sanatorio de la Provodencia

Ciudad Autonoma de Bs As, Argentina

Sanatorio Parque

Rosario, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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