Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer
NCT01061359
ABOUT THIS STUDY
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- Pre- and postmenopausal female patients with histologically confirmed primary breast cancer
- Metastatic breast cancer, locally advanced or recurrent breast cancer, previous cancer
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Descriptive Information | ||||
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Brief Title | Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer | |||
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®)) | |||
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) | |||
Detailed Description | Postmarketing surveillance study. Non-Probability Sample | |||
Study Type | Observational | |||
Study Design | Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Female patients with primary breast cancer | |||
Condition | Breast Neoplasm | |||
Intervention | Drug: Epirubicin: Observational Study
Observational: Chemotherapy | |||
Study Groups/Cohorts | Non-Interventional Study
Chemotherapy containing Epirubicin Intervention: Drug: Epirubicin: Observational Study | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 1981 | |||
Original Actual Enrollment | Same as current | |||
Actual Study Completion Date | October 2009 | |||
Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01061359 | |||
Other Study ID Numbers | 378-ONC-0030-0144 A6051029/MOI99056 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Pfizer | |||
Verification Date | December 2010 |