Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Female

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 primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborators: Aventis Pharmaceuticals; Eli Lilly and Company; Pharmacia and Upjohn
• Treatments: Docetaxel; Epirubicin; Gemcitabine

Criteria

Inclusion Criteria:

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 Criteria:

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.