Status:
COMPLETED
Epirubicin and Docetaxel Combination (ET) or Epirubicin Followed by Docetaxel (E/T) for Node Negative (N0) High Risk Breast Cancer Patients
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
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-po...
Eligibility Criteria
Inclusion
- 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+) (after an amendment on 15.05.2008 women with HER2 (3+) were not included); 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
- 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.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
658 Patients enrolled
Trial Details
Trial ID
NCT00424606
Start Date
June 1 2001
End Date
August 1 2013
Last Update
May 20 2015
Active Locations (12)
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1
University Hospital of Heraklion
Heraklion, Crete, Greece, 71110
2
University Hospital of Alexandroupolis Dept. of Medical Oncology
Alexandroupoli, Greece
3
"Agios Savvas" Anticancer Hospital of Athens
Athens, Greece
4
"IASO" General Hospital of Athens
Athens, Greece