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

Pfizer1,981 enrolled

Overview

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)

Postmarketing surveillance study. Non-Probability Sample

Study Type

OBSERVATIONAL

Enrollment

1,981

Conditions

Breast Neoplasm

Interventions

Epirubicin: Observational StudyDRUG

Observational: Chemotherapy

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Participants With Disease Free Survival (DFS)

Percentage of participants with DFS who completed 5 year follow-up visit.

Time frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y

Secondary Outcomes

Time to Progression (TTP)

Time frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y

Time to Recurrence (DFI)

Time frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y

Data from ClinicalTrials.gov

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