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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2004-10-31

Brief Summary

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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.

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Detailed Description

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Upon determination of eligibility, all patients will receive:

Docetaxel + Epirubicin

Both drugs will be repeated at 21-day intervals

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Docetaxel

Intervention Type DRUG

Epirubicin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No