MedDataX Logo

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

NCT ID: NCT01061359

Last Updated: 2010-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1981 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-01-31

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Postmarketing surveillance study. Non-Probability Sample

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasm

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Breast Cancer Neoadjuvant Treatment Chemotherapy Adjuvant Epirubicin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-Interventional Study

Chemotherapy containing Epirubicin

Epirubicin: Observational Study

Intervention Type DRUG

Observational: Chemotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Epirubicin: Observational Study

Observational: Chemotherapy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=378-ONC-0030-0144&StudyName=Application%20Of%20Epirubicin%20Within%20A%20Neo-/Adjuvant%20Chemotherapy%20In%20Patients%20With%20Primary%20Breast%20Cancer

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A6051029/MOI99056

Identifier Type: -

Identifier Source: secondary_id

378-ONC-0030-0144

Identifier Type: -

Identifier Source: org_study_id