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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00140075
First received: August 29, 2005
Last updated: May 24, 2011
Last verified: May 2011
  Purpose

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
Adenocarcinoma
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,

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00140075

  Show 54 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov 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:
Adenocarcinoma
Breast Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Cyclophosphamide
Taxane
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014