Breast Cancer
Conditions
Keywords
Early breast cancer, Axillary node positive, HER-2 negative, Adjuvant chemotherapy, Dose dense, Docetaxel, FEC
Brief 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
Detailed description
Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. At least five large randomized clinical trials demonstrated that the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an anthracycline-based regimen resulted in superior clinical outcome for women with node positive or high risk node-negative early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer. Data from at least one trial suggest that four cycles of a non-anthracycline but taxane-containing adjuvant regimen (docetaxel plus cyclophosphamide) provide outcomes that are at least as good, if not better than four cycles of doxorubicin/cyclophosphamide combination.
Interventions
DRUGDocetaxel
ARM A: Docetaxel 75 mg/m2 as an IV infusion over 1h on day 1 every 2 weeks for 4 cycles ARM B: Docetaxel 75 mg/m2 as an IV infusion over 1h on day 1 every 3 weeks for 6 cycles
DRUGEpirubicin
ARM A: Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
DRUGCyclophosphamide
ARM A: Cyclophosphamide 500 mg/m2 IV push on day 1 every 2 weeks for 4 cycles ARM B: Cyclophosphamide 600 mg/m2 IV push on day 1 every 3 weeks for 6 cycles
DRUG5-fluoruracil
ARM A: 5-fluoruracil 500 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
Sponsors
University Hospital of Crete
Hellenic Oncology Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 3 years |
| Recurrence rate | Relapses by the time of 3-years follow up |
Countries
Greece
Outcome results
None listed