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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00140075

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 III

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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

ClinicalTrials.gov processed this record on February 12, 2012