Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer

Completed

• Conditions: Breast Neoplasm

• Registration Number: NCT01061359
• Lead Sponsor: Pfizer

Brief Summary

Evaluation of efficacy of treatment with epirubicin (5 years follow-up). Evaluation of frequency of dose reduction. Evaluation of frequency of neoadjuvant treatment with E(120mg) / C(600mg). Evaluation of unexpected and serious adverse events.

(E=Epirubicin; C =Cyclophosphamide)

Detailed Description

Postmarketing surveillance study. Non-Probability Sample

Study Timeline

• Study Start: 1999-01
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Results First Submitted: 2010-10-14
• Results First Submitted QC: 2010-10-14
• Results First Posted: 2010-11-18
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-16
• Last Update Posted: 2010-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1981

Inclusion Criteria

• Pre- and postmenopausal female patients with histologically confirmed primary breast cancer

Exclusion Criteria

• Metastatic breast cancer, locally advanced or recurrent breast cancer, previous cancer history

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Disease Free Survival (DFS)	3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y	Percentage of participants with DFS who completed 5 year follow-up visit.

Secondary Outcome Measures

Name	Time	Method
Time to Progression (TTP)	3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
Time to Recurrence (DFI)	3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y