Sequential Administration of FE75C and Docetaxel Versus Docetaxel/Cyclophosphamide in HER-2 Negative, Node Positive Breast Cancer

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

In this trial investigators propose to assess the dose dense, G-CSF supported sequential administration of 4 cycles of FEC followed by 4 cycles of docetaxel versus 6 cycles of docetaxel/cyclophosphamide as adjuvant chemotherapy in women with HER-2 negative, axillary lymph node positive breast cancer

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; Mitogens

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.