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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
History of Changes
  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:

U.S. FDA Resources

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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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
Adjuvants, Immunologic
Epirubicin
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013