Status:
COMPLETED
Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This protocol will evaluate the feasibility and toxicity of dose-dense docetaxel followed by doxorubicin and cyclophosphamide with support given as adjuvant or neoadjuvant treatment of women with node...
Detailed Description
Upon determination of eligibility, patients will receive: Neoadjuvant Docetaxel + Doxorubicin + Cyclophosphamide + Surgery Adjuvant patients will enter the study after surgery and receive Docetaxel+...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Histologically proven breast cancer
- Females, age greater than 18 years
- Ability to perform activites of daily living with minimal assistance
- Normal cardiac function
- Adequate bone marrow, liver and kidney
- Signed informed consent prior to beginning specific protocol procedures
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Prior systemic anticancer therapy for breast cancer
- Prior anthracycline or taxane based chemotherapy for any malignancy
- Pregnant or breast-feeding women.
- Pre-existing moderate to severe motor or sensory neurotoxicity
- Other serious illness or medical condition
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00193115
Start Date
March 1 2004
End Date
January 1 2009
Last Update
August 4 2010
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