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Completed

NCT Number: NCT00140075

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Epirubicin, ellence,

Epirubicin with a Taxane

Drug

Epirubicin = 75 mg/m2 per cycle

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

Other names: Epirubicin, ellence,

Primary outcomes

  1. Disease free survival at 3 years

    Time frame: 3 years

Secondary outcomes

  1. Assess safety in both treatment arms at 3 years

    Time frame: 3 years

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

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase III, Randomized Study Of Epirubicin/Cyclophosphamide Followed By Taxane (Sequential Chemotherapy) Versus Epirubicin/Taxane (Concurrent Chemotherapy) As Adjuvant Treatment For Operable, Node-Positive Breast Cancer

Important dates

Study start
2000
Primary completion
2006
Study completion
2006
First posted
Aug 31, 2005
Registry last updated
May 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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