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Enzastaurin in Combination of Capecitabine to Treat Breast Cancer

NCT00437294 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2020-08-10

Study results available
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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 breast cancer who were previously treated with an anthracycline and a taxane.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Argentina
  • Australia
  • France
  • Mexico
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00437294 on ClinicalTrials.gov