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

NCT00140075 | Completed Phase 3

• 1 other identifier: 378-ONC-0030-184
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 54

Brief Summary

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.

Conditions

Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Disease free survival at 3 years

  3 years

Secondary Outcomes (2)

• Assess safety in both treatment arms at 3 years

  3 years

• Compare overall survival between the 2 treatment arms at 3 years

  3 years

Study Arms (2)

B

EXPERIMENTAL

ET (8 cycles) T = docetaxel or paclitaxel

Drug: Epirubicin with a Taxane

A

EXPERIMENTAL

EC (4 cycles) followed by T (4 cycles) for a total of 8 cycles T = docetaxel or paclitaxel

Drug: Epirubicin with Cyclophosphamide, followed by a Taxane

Interventions

Epirubicin with Cyclophosphamide, followed by a Taxane DRUG

Epirubicin = 90 mg/m2 Cyclophosphamide = 600 mg/m2 Followed by a taxane; paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2

Also known as: Epirubicin, ellence,

A

Epirubicin with a Taxane DRUG

Epirubicin = 75 mg/m2 per cycle Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2

Also known as: Epirubicin, ellence,

B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Evidence of residual tumor following surgery, or metastatic disease
• Received prior therapy for breast cancer

Sponsors & Collaborators

• Pfizer: lead

Study Sites (54)

Pfizer Investigational Site

Mobile, Alabama, 36608, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85712, United States

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Bakersfield, California, 93309, United States

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Pfizer Investigational Site

Berkeley, California, 94704, United States

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Pfizer Investigational Site

Fountain Valley, California, 92708, United States

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Fountian Valley, California, 92708, United States

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Gilroy, California, 95020, United States

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Poway, California, 92064, United States

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Pfizer Investigational Site

Soquel, California, 95073, United States

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Colorado Springs, Colorado, 80907, United States

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Pfizer Investigational Site

Jacksonville, Florida, 32224, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, 34741, United States

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Lake Worth, Florida, 33461, United States

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Lecanto, Florida, 34461, United States

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Miami, Florida, 33176, United States

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Miami Shores, Florida, 33138, United States

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Port Saint Lucie, Florida, 34952, United States

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Tampa, Florida, 33607, United States

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Atlanta, Georgia, 30309, United States

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Macon, Georgia, 31201, United States

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Belleville, Illinois, 62226, United States

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Pfizer Investigational Site

Skokie, Illinois, 60076, United States

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Pfizer Investigational Site

Baton Rouge, Louisiana, 70809, United States

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Pfizer Investigational Site

New Orleans, Louisiana, United States

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Pfizer Investigational Site

Baltimore, Maryland, 21236, United States

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Pfizer Investigational Site

Baltimore, Maryland, 21237, United States

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Pfizer Investigational Site

Boston, Massachusetts, 02120, United States

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Harper Woods, Michigan, United States

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Hattiesburg, Mississippi, 39401, United States

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Jackson, Mississippi, 39202, United States

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Mount Holly, New Jersey, 08060, United States

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Willingboro, New Jersey, 08046, United States

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Albuquerque, New Mexico, 87102, United States

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Brooklyn, New York, 11235, United States

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Great Neck, New York, 11021', United States

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Staten Island, New York, 10310, United States

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Burlington, North Carolina, 27216, United States

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Greenville, North Carolina, 27854, United States

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Raleigh, North Carolina, 27607, United States

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Pfizer Investigational Site

Lawton, Oklahoma, 73505, United States

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Oklahoma City, Oklahoma, 73104, United States

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Lemoyne, Pennsylvania, 17043, United States

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Philadelphia, Pennsylvania, 19106, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, 29201, United States

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Germantown, Tennessee, 38138, United States

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Knoxville, Tennessee, 37923, United States

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Corpus Christi, Texas, 78412, United States

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Tyler, Texas, 11937, United States

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Pfizer Investigational Site

Arlington, Virginia, 22205, United States

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Pfizer Investigational Site

Portsmouth, Virginia, 23704, United States

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Pfizer Investigational Site

Richmond, Virginia, 23226, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53209, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Adenocarcinoma

Interventions

Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 31, 2005
• Study Start: November 1, 2000
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: May 26, 2011

Record last verified: 2011-05

Locations

US (54)