drugset / Trial / NCT00191789

Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer

NCT00191789 ↗

Phase 2 Completed 65 enrolled Eli Lilly and Company
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.

Timeline

Start
2003-02
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 70 mg/m2 —
Subject Doxorubicin Other / unclassified 60 mg/m2 —
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous