N/A
N=1,972
Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer
Breast Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT01061359 ↗Enrolled (actual)
1,972
Serious AEs
0.8%
Results posted
Nov 2010
Primary outcome: Primary: Percentage of Participants With Disease Free Survival (DFS) — 83.7 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Epirubicin: Observational Study (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Disease Free Survival (DFS) |
83.7 | — |
| SECONDARY Time to Progression (TTP) |
— | — |
| SECONDARY Time to Recurrence (DFI) |
— | — |
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)
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01061359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.