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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 29, 2005
Last updated: May 24, 2011
Last verified: May 2011
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.

Condition Intervention Phase
Drug: Epirubicin with Cyclophosphamide, followed by a Taxane
Drug: Epirubicin with a Taxane
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Disease free survival at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess safety in both treatment arms at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Compare overall survival between the 2 treatment arms at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 606
Study Start Date: November 2000
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B

ET (8 cycles)

T = docetaxel or paclitaxel

Drug: Epirubicin with a Taxane

Epirubicin = 75 mg/m2 per cycle

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

Other Name: Epirubicin, ellence,
Experimental: A

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

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

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

Other Name: Epirubicin, ellence,


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00140075

  Show 54 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00140075     History of Changes
Other Study ID Numbers: 378-ONC-0030-184 
Study First Received: August 29, 2005
Last Updated: May 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Skin Diseases
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on May 24, 2016