PREOPERATIVE HORMONE THERAPY FOR POSTMENOPAUSAL WOMEN WITH ER AND/OR PGR POSITIVE BREAST CANCER: A DOUBLE BLIND RANDOMIZED PARALLEL GROUP PHASE IIB/III TRIAL, COMPARING THE EFFICACY OF 4 MONTHS PREOPERATIVE LETROZOLE (2.5 MG DAILY) WITH PREOPERATIVE TAMOXIFEN (20 MG DAILY)

OVARTIS BIOSCIENSES PERÚ S.A.,0 个研究点目标入组 0 人开始时间: 1999年10月29日最近更新: 2023年9月4日

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•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

•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.

发起方

OVARTIS BIOSCIENSES PERÚ S.A.,