Breast Cancer Clinical Trial

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

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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.

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Eligibility Criteria

Documented late stage breast cancer: stage III A-B (excluding inflammatory breast carcinoma) or localized stage IV breast cancer

Male or female

18 years or older

Adequate bone marrow, liver, and kidney function

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT00286247

Recruitment Status:

Completed

Sponsor:

Introgen Therapeutics

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There is 1 Location for this study

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M.D. Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT00286247

Recruitment Status:

Completed

Sponsor:


Introgen Therapeutics

How clear is this clinincal trial information?

Clinical Trial Resources

SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
Clinical Trials for Breast Cancer
Have You Been Diagnosed With Late-Stage Breast Cancer? Know That You Have Treatment Options.
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