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

This study has been completed.
Sponsor:
Information provided by:
Introgen Therapeutics
ClinicalTrials.gov Identifier:
NCT00286247
First received: February 1, 2006
Last updated: March 28, 2008
Last verified: March 2008

February 1, 2006
March 28, 2008
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Complete list of historical versions of study NCT00286247 on ClinicalTrials.gov Archive Site
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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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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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Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Locally Advanced Breast Cancer (LABC)
Genetic: INGN 201
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00286247
INT 201-010, MDACC ID-00-008
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Introgen Therapeutics
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Introgen Therapeutics
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP