Breast Cancer
Conditions
Keywords
Early breast cancer, Axillary node positive, HER2 overexpression, Adjuvant chemotherapy, Dose dense, Docetaxel, Trastuzumab, FEC
Brief summary
This trial will compare 6 versus 12 months of trastuzumab in combination with dose dense docetaxel following FE75C as adjuvant chemotherapy in women with axillary lymph node positive breast cancer overexpressing HER2
Detailed description
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 administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive 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. Trastuzumab (anti-HER2 monoclonal antibody) in combination with paclitaxel was superior to paclitaxel alone in women with metastatic breast cancer overexpressing HER2
Interventions
DRUGDocetaxel
Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles
DRUGTrastuzumab
Trastuzumab 6 mg/Kg IV over 30 min every two weeks for 4 cycles. Subsequently,trastuzumab 6 mg/Kg IV over 30 min for 12 months
DRUGEpirubicin
Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
DRUGCyclophosphamide
Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
DRUG5-fluoruracil
5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma * HER2/c-neu over expression should be documented by either immunohistochemistry (score 3+) or FISH/CISH positivity. A score of 2+ by immunohistochemistry is acceptable only if FISH/CISH positive * 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 (N0 with HER2/c-neu over expression are also eligible) * 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%). Normal electrocardiogram and absence of significant heart disease * 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 | 5 years |
| Recurrence rate | Relapses by the time of 3-years follow up |
| Τoxicity profile | Toxicity assessment on each chemotherapy cycle |
| Quality of life between the two treatment arms | Assessment every two cycles |
Countries
Greece
Outcome results
None listed