Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Central European Cooperative Oncology Group
Arm A: the FEC75 regimen will be given at the following doses:
Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
Arm B: the FEC90 regimen will be given at the following doses:
Fluorouracil 500mg/m2 by i.v. bolus or infusion.Epirubicin 90mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion.
All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms on Day 2 of each cycle.
Six cycles of adjuvant chemotherapy will be administered in both arms (A + B)
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
patients with histological diagnosis of invasive breast cancer
Patients with early stage I, II,III breast cancer amendable for complete surgical resection.
Patients with any nodal status
Patients with ER and PR -negative tumors. In case of axillary involvement:any hormonal receptors status.
perfomance Status 0-1 on the ECOG Scale
patients indicated for adjuvant chemotherapy
No previous chemotherapy or radiotherapy
Patients have to be randomized within 8 weeks after surgery. Its recommended that patients will start chemotherapy within 1 month after surgical treatment.
You may not be if
active infection
pregnancy/breast feeding
serious concomitant systemic disorders incompatible with the study
Second primary malignancy (expect in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
Use of any other investigational agent within 4 weeks before enrollment into the study
Cocurrent administration of radiation therapy, chemotherapy, hormonal therapy or immunotherapy
Clareo Health | Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer
