Status:
COMPLETED
Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Pharmacia and Upjohn
Eli Lilly and Company
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the prim...
Detailed Description
Upon determination of eligibility, all patients will be receive: Gemcitabine + Epirubicin + Docetaxel
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Adenocarcinoma of the breast confirmed by biopsy
- Female Patients \>18 years of age
- Normal cardiac function
- Ability to perform activities of daily living with minimal assistance
- Chemotherapy naïve or have received prior chemotherapy \> 5 years ago
- Adequate bone marrow, liver and kidney function
- Be informed of the investigational nature of this study
- Sign an informed consent form
- Sentinel lymph node and/or axillary dissection prior to enrollment
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Life expectancy of \< than 6 months
- History of significant heart disease
- Prior chemotherapy or hormonal therapy
- Concurrent Trastuzumab therapy
- History of significant psychiatric disorders
- History of active uncontrolled infection
- 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 :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00193050
Start Date
November 1 2001
End Date
March 1 2009
Last Update
October 26 2021
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