An Open-Label Randomized, Parallel, Two-Arm Phase II Study Comparing BMS-690514 + Letrozole With Lapatinib + Letrozole in Recurrent and Metastatic Breast Cancer Patients Who Are Hormone Receptor Positive Despite HER2 Status And Who Relapsed While Receiving or After Completing Adjuvant Antiendocrine Therapy

CompletadoFase 2ClinicalTrials.gov

ID: NCT01068704Tipo: INTERVENTIONALInicio: 1 de jun de 2010Fin estimado: 1 de dic de 2010

Oncología Endocrinología Obstetricia y Ginecología

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Documented invasive breast cancer
Greater than 10% tumor cells positive for estrogen receptor and/or progesterone receptor
HER2+ and HER2- (Human Epidermal growth factor Receptor) disease
Rapid disease progression despite treatment with tamoxifen, anastrozole or exemestane
ECOG Performance status = 0 or 1

Criterios de exclusión

Prior hormonal therapy for metastatic disease
Prior hormonal therapy with letrozole for adjuvant disease
Symptomatic brain metastases
Prior treatment with any tyrosine kinase inhibitor

Intervenciones

drug

BMS-690514

Tablets, Oral, 200 mg, once daily, \~ 12 months depending on response

drug

Lapatinib

Tablets, Oral, 1500 mg, once daily, \~ 12 months depending on response

drug

Letrozole

Tablets, Oral, 2.5 mg, once daily, \~ 12 months depending on response

Ubicaciones

Local Institution

La Rioja, La Rioja Province, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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