Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer
NCT01061359
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Adult Trials: 18+ Years
- 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 | ||||
|---|---|---|---|---|
| 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 |
| |||
| 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 | |||