Epirubicin and Docetaxel in the Treatment of Patients With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00193024
• Other study ID #: SCRI BRE 39
• Secondary ID: 378-ONC-0030-219
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: May 2, 2011
• Start date: September 2001
• Est. completion date: October 2004

Study information

• Verified date: May 2011
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The epirubicin/docetaxel combination is one of the most active and best tolerated taxane/anthracycline combinations. In this phase II trial, we will further evaluate the feasibility, safety and effectiveness of the docetaxel/epirubicin combination, when administered as first-line treatment for metastatic breast cancer.

Description:

Upon determination of eligibility, all patients will receive:

Docetaxel + Epirubicin

Both drugs will be repeated at 21-day intervals

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: October 2004
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 consent.

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Docetaxel

• Epirubicin

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Aventis Pharmaceuticals, Pharmacia and Upjohn

References & Publications (1)

Hainsworth JD, Yardley DA, Spigel DR, Meluch AA, Rinaldi D, Schnell FM, Greco FA. Docetaxel and epirubicin as first-line treatment for patients with metastatic breast cancer: a Minnie Pearl Cancer Research Network Phase II trial. Cancer Invest. 2006 Aug-S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
Secondary	Safety of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer

External Links

•   Published article in Cancer Investigation