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

Lilly

Status and phase: Completed; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: capecitabine; Drug: gemcitabine; Drug: docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191438

6136

B9E-MC-S273

Details and patient eligibility

About

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

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients with inflammatory breast disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)