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

• Conditions: MedDRA version: 8.0Level: PTClassification code 10055113; hormone-receptor-positive metastatic breast cancer

• Registration Number: EUCTR2005-001701-26-DE
• Lead Sponsor: CESAR Central European Society for

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 550

Inclusion Criteria

-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

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified