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

Tracking Information

First Received Date ^ICMJE

August 29, 2005

Last Updated Date

March 17, 2008

Start Date ^ICMJE

November 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Disease free survival at 3 years

Change History

Complete list of historical versions of study NCT00140075 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Safety and Efficacy - assess safety in both treatment arms at 3 years; compare overall survival between the 2 treatment arms at 3 years

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Adenocarcinoma

Intervention ^ICMJE

Drug: Epirubicin with Cyclophosphamide, followed by a Taxane
Drug: Epirubicin with a Taxane

Study Arms / Comparison Groups

Experimental:
ET (8 cycles)

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

T = docetaxel or paclitaxel

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

603

Estimated Completion Date

December 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00140075

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc

Study ID Numbers ^ICMJE

378-ONC-0030-184

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP