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A Phase II Trial of Epirubicin/Docetaxel in the First-Line Treatment of Patients With Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Phase II Trial of Epirubicin/Docetaxel in the First-Line Treatment of Patients With Metastatic Breast Cancer

Upon determination of eligibility, all patients will receive:

Docetaxel + Epirubicin

Both drugs will be repeated at 21-day intervals

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

- Metastatic breast cancer confirmed by biopsy.

- Received no previous chemotherapy for metastatic breast cancer.

- Prior hormonal therapy is acceptable.

- Measurable or evaluable disease.

- Able to perform activities of daily living without considerable assistance

- Adequate bone marrow, liver and kidney function

- Must be able to understand the nature of this study and give written informed

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

- Age < 18 years.

- Cardiac ejection fraction < 45%.

- Women who are pregnant or lactating.

- Patients with meningeal metastases are ineligible.

- Moderate peripheral neuropathy

- History of hypersensitivity reaction to Taxotere

- Males with metastatic breast cancer

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:


Study Design:

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

Outcome Measure:

Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

September 2001

Completion Date:

October 2004

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms