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NCT01061359 Clinical Trial

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

Breast Neoplasm Clinical Trial

Official title:
Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer ((ANWENDUNGSBEOBACHTUNG,MOI 99056 -Neo-/Adjuvante Chemotherapie Des Primären Mammakarzinoms Der Frau Mit Farmorubicin®))

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01061359
Other study ID # 378-ONC-0030-0144
Secondary ID A6051029/MOI9905
Status Completed
Phase N/A
First received February 1, 2010
Last updated December 16, 2010
Start date January 1999
Est. completion date October 2009

Study information
Verified date December 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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)

Description:

Postmarketing surveillance study. Non-Probability Sample

Recruitment information / eligibility
Status Completed
Enrollment 1981
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Epirubicin: Observational Study
Observational: Chemotherapy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Disease Free Survival (DFS) Percentage of participants with DFS who completed 5 year follow-up visit. 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y No
Secondary Time to Progression (TTP) 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y No
Secondary Time to Recurrence (DFI) 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y No
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