Clinical trial NCT00140075: Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adenocarcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 606
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Disease free survival at 3 years
timeFrame: 3 years
Secondary outcomes:
measure: Assess safety in both treatment arms at 3 years
timeFrame: 3 years
measure: Compare overall survival between the 2 treatment arms at 3 years
timeFrame: 3 years
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Bakersfield
country: United States
facility: Pfizer Investigational Site
state: California
city: Berkeley
country: United States
facility: Pfizer Investigational Site
state: California
city: Fountain Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Fountian Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Gilroy
country: United States
facility: Pfizer Investigational Site
state: California
city: Poway
country: United States
facility: Pfizer Investigational Site
state: California
city: Soquel
country: United States
facility: Pfizer Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lake Worth
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lecanto
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami Shores
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Port St. Lucie
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Macon
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Belleville
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Harper Woods
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Hattiesburg
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Mt. Holly
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Willingboro
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: Great Neck
country: United States
facility: Pfizer Investigational Site
state: New York
city: Staten Island
country: United States
facility: Pfizer Investigational Site
state: New York
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Lawton
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Lemoyne
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Germantown
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Corpus Christi
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Tyler
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Portsmouth
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: