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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014