- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01061359
Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer
December 16, 2010 updated by: Pfizer
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®))
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Postmarketing surveillance study.
Non-Probability Sample
Study Type
Observational
Enrollment (Actual)
1981
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Female patients with primary breast cancer
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Non-Interventional Study
Chemotherapy containing Epirubicin
|
Observational: Chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to Progression (TTP)
Time Frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
|
3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
|
Time to Recurrence (DFI)
Time Frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
|
3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1999
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
February 1, 2010
First Submitted That Met QC Criteria
February 2, 2010
First Posted (Estimate)
February 3, 2010
Study Record Updates
Last Update Posted (Estimate)
December 29, 2010
Last Update Submitted That Met QC Criteria
December 16, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 378-ONC-0030-0144
- A6051029/MOI99056
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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