Epirubicin and Docetaxel Combination (ET) or Epirubicin Followed by Docetaxel (E/T) for Node Negative (N0) High Risk Breast Cancer Patients
Information source: Hellenic Oncology Research Group
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Docetaxel (Drug); Epirubicin (Drug); Epirubicin (Drug); Docetaxel (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hellenic Oncology Research Group Official(s) and/or principal investigator(s):
Dimitris Mavrudis, MD, Principal Investigator, Affiliation: University Hospital of Heraklion Dept. of Medical Oncology
Overall contact:
Dora Hatzidaki, Phone: +302810392570, Email: dorachat@med.uoc.gr
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Disease-free interval between the two treatment arms
Secondary outcome: Comparison of overall survival and safety between the two treatment arms
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Dora Hatzidaki, Phone: +302810392570, Email: dorachat@med.uoc.gr
"Laikon" General Hospital, Athens, Greece; Recruiting
George Tavoularis, Phone: +302106457968, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Aris Polyzos, MD, Principal Investigator
"Marika Iliadis" Hospital of Athens, Athens, Greece; Recruiting
George Tavoularis, Phone: +302106457968, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Nikos Malamos, MD, Principal Investigator
"Metaxa's" Anticancer Hospital of Pireas, Athens, Greece; Recruiting
George Tavoularis, Phone: +302106457968, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Nikos Ziras, MD, Principal Investigator
"IASO" General Hospital of Athens, Athens, Greece; Recruiting
George Tavoularis, Phone: +302106457968, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Stelios Giassas, MD, Principal Investigator
401 Military Hospital of Athens, Athens, Greece; Recruiting
George Tavoularis, Phone: +302106457968, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Charalampos Christophillakis, MD, Principal Investigator
Air Forces Military Hospital of Athens, Athens, Greece; Recruiting
George Tavoularis, Phone: +302106457968, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Nikos Kentepozidis, MD, Principal Investigator
"Agios Savvas" Anticancer Hospital of Athens, Athens, Greece; Recruiting
George Tavoularis, Phone: +302106457968, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Alekos Ardavanis, MD, Principal Investigator
State General Hospital of Larissa, Larissa, Greece; Recruiting
George Tavoularis, Phone: +302106457968, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Athanasios Athanasiadis, MD, Principal Investigator
"Theagenion" Anticancer Hospital of Thessaloniki, Thessaloniki, Greece; Recruiting
George Tavoularis, Phone: +302106457968, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Ioannis Boukovinas, MD, Principal Investigator
"AXEPA" General Hospital of Thessaloniki, Thessaloniki, Greece; Recruiting
George Tavoularis, Phone: +302106457968, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Paris Makrantonakis, MD, Principal Investigator
University Hospital of Alexandroupolis Dept. of Medical Oncology, Alexandroupolis, Greece; Recruiting
George Tavoularis, Phone: +302106457968, Email: secretary@horg.gr
Spyros Georgiadis, Phone: +302106457968, Email: secretary@horg.gr
Stelios Kakolyris, MD, Principal Investigator
University Hospital of Heraklion, Heraklion, Crete 71110, Greece; Recruiting
Dora Hatzidaki, Phone: +302810392570, Email: dorachat@med.uoc.gr
Dimitris Mavrudis, MD, Principal Investigator
Additional Information
Starting date: April 2002
Ending date: April 2013
Last updated: July 15, 2008
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