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

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ClinicalTrials.gov Identifier: NCT01061359
Recruitment Status : Completed
First Posted : February 3, 2010
Results First Posted : November 18, 2010
Last Update Posted : December 29, 2010
Sponsor:
Information provided by:
Pfizer

Brief 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)


Condition or disease Intervention/treatment
Breast Neoplasm Drug: Epirubicin: Observational Study

Detailed Description:
Postmarketing surveillance study. Non-Probability Sample

Study Type : Observational
Actual Enrollment : 1981 participants
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®))
Study Start Date : January 1999
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
Non-Interventional Study
Chemotherapy containing Epirubicin
Drug: Epirubicin: Observational Study
Observational: Chemotherapy



Primary Outcome Measures :
  1. 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 ]
    Percentage of participants with DFS who completed 5 year follow-up visit.


Secondary Outcome Measures :
  1. Time to Progression (TTP) [ Time Frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y ]
  2. Time to Recurrence (DFI) [ Time Frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061359


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

Additional Information:
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
First Posted: February 3, 2010    Key Record Dates
Results First Posted: November 18, 2010
Last Update Posted: December 29, 2010
Last Verified: December 2010

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epirubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action