Clareo Health | Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer
Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer
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Keep this study
Lead
Hellenic Oncology Research Group
With
University Hospital of Crete
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 versus 4 cycles of paclitaxel as adjuvant chemotherapy in women with axillary lymph node positive breast cancer
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
