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 sites550 target enrollmentAugust 21, 2006

Overview

No summary available.

Registry

who.int

Start Date

August 21, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

CESAR Central European Society for

•\-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.

•\-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).