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Completed

NCT Number: NCT01061359

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

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)

Completed

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

About this study

Postmarketing surveillance study. Non-Probability Sample

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epirubicin: Observational Study

Drug

Observational: Chemotherapy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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®))

Important dates

Study start
1999
Primary completion
2009
Study completion
2009
First posted
Feb 3, 2010
Registry last updated
Dec 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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