Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer

NCT ID: NCT00140075

Last Updated: 2011-05-26

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

606 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2006-08-31

Brief Summary

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The purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. The study will also evaluate the side effects of both treatment combinations.

Detailed Description

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Conditions

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Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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B

ET (8 cycles)

T = docetaxel or paclitaxel

Group Type EXPERIMENTAL

Epirubicin with a Taxane

Intervention Type DRUG

Epirubicin = 75 mg/m2 per cycle

Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2

A

EC (4 cycles) followed by T (4 cycles) for a total of 8 cycles

T = docetaxel or paclitaxel

Group Type EXPERIMENTAL

Epirubicin with Cyclophosphamide, followed by a Taxane

Intervention Type DRUG

Epirubicin = 90 mg/m2 Cyclophosphamide = 600 mg/m2

Followed by a taxane; paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2

Interventions

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Epirubicin with Cyclophosphamide, followed by a Taxane

Epirubicin = 90 mg/m2 Cyclophosphamide = 600 mg/m2

Followed by a taxane; paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2

Intervention Type DRUG

Epirubicin with a Taxane

Epirubicin = 75 mg/m2 per cycle

Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2

Intervention Type DRUG

Other Intervention Names

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Epirubicin, ellence, Epirubicin, ellence,

Eligibility Criteria

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Inclusion Criteria

* Breast Cancer Stage T1-3, N1, M0
* Suitable candidate for anthracycline-containing adjuvant chemotherapy

Exclusion Criteria

* Evidence of residual tumor following surgery, or metastatic disease
* Received prior therapy for breast cancer
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Mobile, Alabama, United States

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Tucson, Arizona, United States

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Bakersfield, California, United States

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Berkeley, California, United States

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Fountain Valley, California, United States

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Fountian Valley, California, United States

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Gilroy, California, United States

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Poway, California, United States

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Soquel, California, United States

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Colorado Springs, Colorado, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Lake Worth, Florida, United States

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Lecanto, Florida, United States

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Miami, Florida, United States

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Miami Shores, Florida, United States

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Port Saint Lucie, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Macon, Georgia, United States

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Belleville, Illinois, United States

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Skokie, Illinois, United States

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Baton Rouge, Louisiana, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Harper Woods, Michigan, United States

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Hattiesburg, Mississippi, United States

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Jackson, Mississippi, United States

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Mount Holly, New Jersey, United States

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Willingboro, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Great Neck, New York, United States

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Staten Island, New York, United States

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Burlington, North Carolina, United States

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Greenville, North Carolina, United States

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Raleigh, North Carolina, United States

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Lawton, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Lemoyne, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Germantown, Tennessee, United States

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Knoxville, Tennessee, United States

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Corpus Christi, Texas, United States

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Tyler, Texas, United States

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Arlington, Virginia, United States

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Portsmouth, Virginia, United States

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Richmond, Virginia, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

Related Links

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Other Identifiers

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378-ONC-0030-184

Identifier Type: -

Identifier Source: org_study_id

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