A Double-Blind, Randomized, Phase 2 Trial of Capecitabine Plus Enzastaurin Versus Capecitabine Plus Placebo in Patients With Metastatic or Recurrent Breast Cancer Previously Treated With an Anthracycline and a Taxane

TerminadoFase 2ClinicalTrials.gov

ID: NCT00437294Tipo: INTERVENTIONALInicio: 1 de mar de 2007Fin estimado: 1 de mar de 2009

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Have been diagnosed with metastatic or recurrent breast cancer.
Have been previously treated with both an anthracycline and a taxane.
Have not received more than two prior chemotherapy treatment programs.
Have stopped any antitumoral hormonal treatment before you enroll in this study.
Have a negative pregnancy blood test if menstruating or capable of becoming pregnant. You must use an approved birth control method during the study and for 3 months after stopping study treatment.

Criterios de exclusión

Cannot follow the study procedures (for example, you cannot swallow tablets).
Are receiving another treatment for your cancer.
Have received another experimental drug in the last 4 weeks.
Have had serious heart disease within last 6 months.
Are pregnant or breast-feeding.

Intervenciones

drug

enzastaurin

1125 milligrams (mg) loading dose then 500 mg, oral, daily, 21-day cycles until progressive disease

drug

placebo

oral, daily, 21-day cycles until progressive disease

drug

capecitabine

1250 mg/m\^2, BID, days 1-14 of each 21-day cycle until progressive disease

Ubicaciones

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Buenos Aires, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Resistencia, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tucumain, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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