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Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients


Upon determination of eligibility, all patients will be receive:

Gemcitabine + Epirubicin + Docetaxel


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic Complete Response (pCR)

Outcome Time Frame:

18 Months

Safety Issue:

No

Principal Investigator

Denise A. Yardley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Institutional Review Board

Study ID:

SCRI BRE 51

NCT ID:

NCT00193050

Start Date:

November 2001

Completion Date:

March 2009

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms
  • Inflammatory Breast Neoplasms

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