Status:
COMPLETED
Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. In at least three large randomized clinical trials the addition or sequential admini...
Detailed Description
This trial will compare the dose dense, G-CSF supported sequential administration of 4 cycles of 5-Fluoruracil (F) plus Epirubicin (E 75mg/m2) plus Cyclofosfamide (C) followed by 4 cycles of docetaxel...
Eligibility Criteria
Inclusion
- Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
- Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
- Tumor involvement of at least one axillary lymph node
- Absence of any clinical or radiological evidence of local or metastatic disease
- Premenopausal or postmenopausal women aged 18-75 years old
- Adequate bone marrow function (absolute neutrophil count \>1500/mm3, platelet count \>100.000/mm3, hemoglobin \>10gr/mm3)
- Adequate liver (bilirubin \<1.0 times upper limit of normal and SGOT/SGPT \<2.5 times upper limit of normal) and renal function (creatinine \<1.5mg/dl)
- Adequate cardiac function (LVEF\>50%)
- Written informed consent
Exclusion
- Positive pregnancy test.
- Psychiatric illness or social situation that would preclude study compliance.
- Other concurrent uncontrolled illness.
- Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
- Previous history of other invasive malignancy other than non-melanomatous skin cancer.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
478 Patients enrolled
Trial Details
Trial ID
NCT00431080
Start Date
August 1 2004
End Date
October 1 2007
Last Update
January 21 2008
Active Locations (10)
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1
University Hospital of Crete
Heraklion, Crete, Greece, 71110
2
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
3
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
4
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece