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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01061359
First received: February 1, 2010
Last updated: December 16, 2010
Last verified: December 2010
  Purpose

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)


Condition Intervention
Breast Neoplasm
Drug: Epirubicin: Observational Study

Study Type: Observational
Study Design: Time Perspective: Prospective
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®))

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Disease Free Survival (DFS) [ Time Frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y ] [ Designated as safety issue: No ]
    Percentage of participants with DFS who completed 5 year follow-up visit.


Secondary Outcome Measures:
  • Time to Progression (TTP) [ Time Frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y ] [ Designated as safety issue: No ]
  • Time to Recurrence (DFI) [ Time Frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y ] [ Designated as safety issue: No ]

Enrollment: 1981
Study Start Date: January 1999
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non-Interventional Study
Chemotherapy containing Epirubicin
Drug: Epirubicin: Observational Study
Observational: Chemotherapy

Detailed Description:

Postmarketing surveillance study. Non-Probability Sample

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Female patients with primary breast cancer

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061359

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01061359     History of Changes
Other Study ID Numbers: 378-ONC-0030-0144, A6051029/MOI99056
Study First Received: February 1, 2010
Results First Received: October 14, 2010
Last Updated: December 16, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pfizer:
Breast Cancer
Neoadjuvant Treatment
Chemotherapy
Adjuvant
Epirubicin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Epirubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014