First- Line Treatment of Postmenopausal Patients with Endocrine Responsive Metastatic Breast Cancer. A Randomized, Multicenter Study Comparing Letrozole Combined with Standard Chemotherapy Vs Letrozole Single Agent. The CELER (= CEsar LEtrozole Randomized phase III) Study - CELER Study

CESAR Central European Society for0 个研究点目标入组 550 人开始时间: 2006年1月25日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•-Postmenopausal women defined by at least one of the following criteria:
•women >50 years: no spontaneous menses for at least 2 years
•Any age: no spontaneous menses in the last 1 year with FSH, LH and estradiol levels in the postmenopausal range for the laboratory of reference
•Any age: bilateral oophorectomy or castration via radiotherapy with amenorrhea lasting > 3 months.
•-Histological or cytological evidence of breast cancer.
•-Estrogen and/or progesterone receptors positive, according to the definition of the reference laboratory, evaluated on the primary tumor or on a metastasis.
•-Patients with documented measurable and/or non-measurable metastatic disease according to RECIST criteria; patients with bone metastases as only site of disease are also eligible.
•-Performance Status 0-2 (ECOG scale).
•-Life expectancy > 6 months.
•-Adequate bone marrow reserve as evaluated with peripheral pretreatment values of Hb >10 g/dL, WBC > 3500/uL, Platelets > 100.000 > ?L.
•-Adequate renal function (creatinine within the normal range for the institution).
•-Adequate liver function (bilirubin within the normal range and liver enzymes < 2.5 times the normal upper limit for the institution).
•-Written informed consent.
•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

•-Patients who according to the treating physician require chemotherapy.
•-Patients considered for curative surgery
•-Prior systemic antitumor therapy for metastatic breast cancer.
•-If an anthracycline containing chemotherapy is chosen: Prior application of anthracyclines during adjuvant chemotherapy to an extent that would compromise an adequate dosage in anthracycline containing chemotherapy as first-line treatment.
•-Systemic investigational drugs within the prior month.
•-Treatment with trastuzumab (Herceptin) containing regimens .
•-Prior use of aromatase inhibitors.
•-Patients receiving LHRH agonists/antagonists.
•-Known CNS metastases
•-Uncontrolled cardiac disease (i.e. severe hypertension, angina pectoris despite treatment, history of uncontrolled atrial or ventricular arrhythmia, myocardial infarction in the prior six months).
•-Other concurrent or previous malignancies within the last 5 years except for contralateral breast carcinoma, cone biopsied in-situ carcinoma of the cervix uteri or adequately treated basal or squamous cell carcinoma of the skin.
•-History of non compliance to medical regimens and patients who are considered unreliable.
•-Any contraindication for the selected chemotherapy regimen.

发起方

CESAR Central European Society for