Status:

TERMINATED

Enzastaurin in Combination of Capecitabine to Treat Breast Cancer

Lead Sponsor:

Eli Lilly and Company

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

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 breas...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

March 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

86 Patients enrolled

Trial Details

Trial ID

NCT00437294

Start Date

March 1 2007

End Date

March 1 2009

Last Update

August 10 2020

Active Locations (20)

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Page 1 of 5 (20 locations)

1

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, 1430

2

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, 3500

3

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, 4000

4

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.

Garran, Australian Capital Territory, Australia, 2605