A randomised multi-center Phase IIIb, open label, study of letrozole vs anastrazole in the adjuvant treatment of postmenopausal women with hormone receptor and node positive breast cancerEstudio multicéntrico, aleatorizado, abierto y de fase IIIb de comparación de letrozol frente a anastrozol en el tratamiento complementario de las mujeres posmenopáusicas con cáncer de mama con afectación ganglionar y receptores hormonales positivos

ovartis Farmacéutica SA0 个研究点目标入组 4,032 人开始时间: 2006年3月27日最近更新: 2014年10月27日

试验速览

暂无简介。

•provision of written informed consent
•undergone a total mastectomy, a lumpectomy, or a quadrantectomy for primary breast cancer.
•the date of randomization must be no more than:
•4 weeks from completion of surgery or.
•4 weeks after completion of adjuvant chemotherapy.
•Note adjuvant radiation and endocrine therapy e.g. letrozole and anastrozole can be given at the same time as radiotherapy due to non-overlapping toxicity profile.
•presence of node positive disease.
•receptor-positive tumors, defined ER =10 fmol/mg cytosol protein; or =10% of the tumor cells positive by immunocytochemical evaluation.
•postmenopausal whether induced by surgery, radiotherapy or chemotherapy, or by being naturally amenorrheic, for 1 year or more if younger than 50 and for 6 months if 50 or older.
•postmenopausal levels of FSH/LH/E2 (follicle stimulating hormone, luteinizing hormone, estrogen) according to the definition of postmenopausal range” for the laboratory involved.
•WBC = 3.0 x 109/L, granulocytes = 1.5 X 109/L and platelets = 100 x 109/L.
•AST/SGOT or ALT/SGPT = 3 times ULN.
•serum creatinine = 2 times ULN.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•presence of metastatic disease.
•concomitant or prior bilateral breast cancer.
•previous or concomitant other (non-breast cancer) malignancy within the previous 5 years.
•presence of other non-malignant systemic diseases which may prevent prolonged follow-up.
•if no history of previous coronary heart disease but has at least two other coronary heart disease risk factors: LDL =160 mg/dL OR if fewer than two other coronary heart disease risk factors: LDL =190 mg/dL.
•total fasting cholesterol = ?240 mg/dL.
•patients on lipid-lowering agents, diet, or other measures for hyperlipidemia at baseline.
•progressed on neoadjuvant endocrine therapy
•hormone replacement therapy (HRT) within 4 weeks before trial treatment was initiated.
•adjuvant anti-estrogen therapy for more than 1 month immediately following surgery, radiotherapy and/or chemotherapy.
•Breast cancer chemoprevention with anti-estrogens if less than 18 months between stopping and diagnosis of breast cancer.
•Severe hepatic dysfunction defined as Child-Pugh grade C.

发起方

ovartis Farmacéutica SA