Phase III Study of Gemcitabine Plus a Cytotoxic Agent Versus Two Cytotoxic Agents

Phase 3CompletedNCT00191438

Eli Lilly and Company300 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Breast Neoplasms

Interventions

gemcitabineDRUG

capecitabineDRUG

docetaxelDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Locally advanced and/or metastatic breast cancer. * Measurable disease * Previously treated with anthracycline Exclusion Criteria: * Patients with inflammatory breast disease

Locations (6)

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

Saint-Herblain, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

Overall toxicity

Quality of Life

Overall Survival

Overall Response Rate

Time to Treatment Failure

Data from ClinicalTrials.gov

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