Epirubicin and Docetaxel Combination (ET) or Epirubicin Followed by Docetaxel (E/T) for Node Negative (N0) High Risk Breast Cancer Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

January 18, 2007

Last Updated Date

September 25, 2009

Start Date ^ICMJE

April 2002

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Disease-free interval between the two treatment arms [ Time Frame: Five years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Comparison of Disease-free interval between the two treatment arms at five years

Change History

Complete list of historical versions of study NCT00424606 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Comparison of overall survival and safety between the two treatment arms [ Time Frame: Five years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Comparison of Overall survival and safety between the two treatment arms

Descriptive Information

Brief Title ^ICMJE

Epirubicin and Docetaxel Combination (ET) or Epirubicin Followed by Docetaxel (E/T) for Node Negative (N0) High Risk Breast Cancer Patients

Official Title ^ICMJE

A Multicenter Randomized Phase III Study of Adjuvant Treatment With Epirubicin Followed by Docetaxel (E/T) Versus Epirubicin and Docetaxel Combination (ET) in High Risk Lymph Node Negative Breast Cancer Patients

Brief Summary

The combination of taxanes, and especially docetaxel, with an anthracycline seems to be an important part of the chemotherapy regimens used in the adjuvant setting of patients with early-stage node-positive breast cancer patients. Whether sequential or concurrent administration of these drugs is preferable is not yet known, especially in patients with node-negative high risk tumors.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: Docetaxel
Drug: Epirubicin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

724

Estimated Completion Date

April 2013

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histologically or cytologically confirmed breast adenocarcinoma.
Within 20-45 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
Absence of lymph node involvement after eclosion and hormone (E&H) staining and light microscopy evaluation.
Premenopausal or postmenopausal women with at least one of the following tumor characteristics is required in order to characterize the tumor as high risk:
- Estrogen receptor (ER) (-) and progesterone receptor (PR)(-);
- Ki-67 + > 30%; Grade III; HER2 (3+);Perineural infiltration or presence of tumor emboli in blood or lymph vessels.
Postmenopausal women with tumors 1-2 cm are eligible if the tumor has at least 2 of the above mentioned high risk criteria.
Premenopausal and postmenopausal women with tumors measuring > 2 cm are eligible irrespectively of the expression of the above adverse prognostic tumor criteria.
Absence of any clinical or radiological evidence of local or metastatic disease.
Age > 18 years.
Performance status (WHO) < 3.
Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3).
Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2 mg/dl).
Adequate cardiac function (LVEF > 50%).
Negative pregnancy test.
Informed consent.

Exclusion Criteria:

Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
Other concurrent uncontrolled illness that could affect compliance with the study.
Psychiatric illness or social situation that would preclude study compliance.
Pregnant or nursing women.
History of allergic reaction attributed to docetaxel.
Other concurrent investigational agents.

Gender

Female

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dora Hatzidaki	+302810392570	dorachat@med.uoc.gr
Contact: Sofia Mavraki	+302810392987

Location Countries ^ICMJE

Greece

Administrative Information

NCT ID ^ICMJE

NCT00424606

Responsible Party

V. Georgoulias, Hellenic Oncology Research Group

Study ID Numbers ^ICMJE

CT/01.04

Study Sponsor ^ICMJE

Hellenic Oncology Research Group

Collaborators ^ICMJE

University Hospital of Crete

Investigators ^ICMJE

Principal Investigator:

Dimitris Mavrudis, MD

University Hospital of Heraklion Dept. of Medical Oncology

Information Provided By

Hellenic Oncology Research Group

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP