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
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