None listed
Conditions
Interventions
Patients received either letrozole 2 5 mg or tamoxifen 20 mg orally once daily for four months prior to surgery unless the patient was withdrawn earlier due to progressive disease (PD), an adverse event, or patient/investigator request Surgery was scheduled four months from the date the patient received her first treatment to ensure that there was no interval between the last study treatment day and the patient´s operation Patients were considered to have completed the study when they had receiv
see description above
Sponsors
NOVARTIS BIOSCIENSES PERÚ S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. were poslmenopausal women with untreated primary breast cancer, confirmed by core needle biopsy, with 10% nuclear Postmenopausal breast cancer patients with ER and/or PgR positive tumors, 2.Clinical staging mandated T2-4a-c,NO-2, MO tumors. 3.defined postmenopausal status 4. Tumors, measurable by clinical examination, mammography and ultrasound. 5. Proper functioning of bone marrow(RC >3.5 x109/L . plaquetes >100.0 x109/L, and Hb 11.0 g/dL). 6. Adequate renal founction (<120 umol/L ) and liver function (bilirrubine < 25 :umol/L, AST (SGOT <60 U/L). 7. a life expectancy of at least six months 8. written informed consent
Exclusion criteria
Exclusion criteria: 1. prior exposure to letrozole or tamoxifen. 2. . endocrine pathology: DM, confirmed hypothyroidism, sd. Cushing, Addison´s disease (treated or not). 3. Patients with unstable angina or uncontrolled heart disease (Class III / IV) 4. Patients with bilateral breast tumors 5. candidates for conservative surgery 6. evidence of inflammatory breast cancer or metastasis 7. any other neoplasm, except ca uterine cervix treated with conization or basal or squamous cell carcinoma of adequately treated skin or other cancer curable as hodking lymphoma and not hodking if more than 5 years have passed and there has been no recurrence. 8. Concomitant antineoplastic treatment QT, immunotherapy, MRB, endocrine therapy, bisphosphonates and radiotherapy. Patients who have received THR will not be excluded if it is found to have been discontinued 2 weeks before the trial. 9. Concomitant treatment with steroids for other indications than cancer, with the exception of aerosols for COPD and intra-articular injection as an anti-inflammatory treatment. 10. Other experimental drugs. 11. History of non-compliance with medical treatment or unreliable patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:palpation Measure:response clinical rate Timepoints:at 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:percentage of patients who undergo breast conserving surgery (lumpectomy/quadrantectomy)instead of mastectomy. Measure:breast conserving surgery Timepoints:at surgery ; Outcome name:mammography and ultrasound Measure:Response rate (complete response CR+partial response PR) Timepoints:at 4 months ; Outcome name:percentage of patients alive in each treatment arm Measure:overall survival Timepoints:at 5 years post surgery | — |
Outcome results
None listed