None listed
Conditions
Interventions
Tamoxifen + Navelbine Type of group
20 mg Tamoxifen daily + 30 mg / m2 Navelbine on day 1 and 8 every 3 weeks for a period of 3 to 6 cycles
Sponsors
Institut de Recherche Pierre,
Eligibility
Inclusion criteria
Inclusion criteria: • Women with locally advanced breast carcinoma histologically confirmed with T> 3 cm (excluding T4d) requiring radical mastectomy • Patients not previously submitted to chemotherapy, hormone therapy, radiotherapy or immunotherapy for the treatment of locally advanced disease. • 60 years old • Patients with evaluable primitive lesion. • Patients with Performance Status <2 according to ECOG / OMS • Patients with a life expectancy of more than 3 months. • Patients with positive estrogen receptors. • Patients who have signed the consent form after having been informed in detail about the study by the participating physician and before having been subjected to any specific procedure of the study.
Exclusion criteria
Exclusion criteria: • Patients with T4d are excluded. • Patients with symptoms of brain disorders or presence of metastatic disease. • Patients with uncontrolled infection. • Physically unstable patients (for example, unstable diabetes or uncontrolled high blood pressure) • Patients with other malignancies except basal cell carcinoma of the skin or carcinoma of the cervix located and adequately treated. • Patients who have at least one of the following laboratory values: Neutrophils 1.5 x N (N - the maximum normal value), Transaminases> 2.5 x N (N - the maximum normal value), Creatinine 130 umoles / l or WHO grade I • Patients who have participated in a drug research study in the previous 30 days. • Psychological, family, sociological or geographic conditions that do not allow medical follow-up and compliance with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:• Physical examination (mandatory) • Mammography + ultrasound examination of the breast (mandatory) • Abdominal CT scan (mandatory) • Thoracic radiography (mandatory) • Bone tomography (mandatory) • ultrasound examination of the breast and armpits (if necessary) Measure:Efficacy Timepoints:Evaluations every 3 treatment cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical History, Physical Examination, Performance status, GSB, differential, platelets, SGOT, SGPT, Gamma-GT, alkaline phosphatase and total bilirubin Measure:Safety Timepoints:During each of the cycles | — |
Outcome results
None listed