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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Locally Advanced Breast Cancer (LABC)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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INGN 201

Intervention Type GENETIC

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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MDACC ID-00-008

Identifier Type: -

Identifier Source: secondary_id

INT 201-010