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

Completed · Phase 2

Conditions studied: Locally Advanced Breast Cancer (LABC)

In brief

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.

Key facts

Study ID

NCT00286247

Run by

Introgen Therapeutics

People needed

60

Last updated by the study team

2008-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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