drugset / Trial / NCT00286247

Study to Determine the Efficacy and Safety of Docetaxel and Doxorubicin With INGN 201 in Locally Advanced Breast Cancer

NCT00286247

Phase 2 Completed 60 enrolled Introgen Therapeutics
Non-randomizedSingle-groupOpen-labelTreatment

Summary

A maximum of 60 subjects will be enrolled in the trial. It is a non-randomized, open label, single center study. All subjects undergo INGN 201 injection and IV chemotherapy: doxorubicin and docetaxel. This is done on the first 2 days of a 3-week cycle. After completion of 4 to 6 cycles, the subject either proceeds to surgery if the tumors respond to therapy, or goes off study if there is no tumor response.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject CONTUSUGENE LADENOVEC Unknown Other

Indications