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Clinical Trials/NCT00191438
NCT00191438
Completed
Phase 3

Phase III Study of Docetaxel in Combination With Gemcitabine Versus Docetaxel in Combination With Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer

Eli Lilly and Company1 site in 1 country300 target enrollmentOctober 2002
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ConditionsBreast Neoplasms
Drugsgemcitabinecapecitabinedocetaxel

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Breast Neoplasms
Sponsor
Eli Lilly and Company
Enrollment
300
Locations
1
Primary Endpoint
Progression free survival. The final analysis will occur when 250 patients have progressed or died.
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This is a phase III randomized study which compares two different regimens of chemotherapy. The purpose of the study is to determine which of the two regimens will make the tumor smaller or disappear, and for how long. In addition the disease-related symptoms will be evaluated. The safety of the drugs will be determined based upon evaluation of the side effects

Registry
clinicaltrials.gov
Start Date
October 2002
End Date
March 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Locally advanced and/or metastatic breast cancer.
  • •Measurable disease
  • •Previously treated with anthracycline

Exclusion Criteria

  • •Patients with inflammatory breast disease

Outcomes

Primary Outcomes

Progression free survival. The final analysis will occur when 250 patients have progressed or died.

Secondary Outcomes

  • Quality of Life
  • Overall Survival
  • Overall Response Rate
  • Time to Treatment Failure
  • Overall toxicity

Study Sites (1)

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