hormone-receptor-positive metastatic breast cancer MedDRA version: 8.0 Level: PT Classification code 10055113
Conditions
Interventions
Trade Name: Femara-Filmtabletten
Product Name: Femara
Product Code: Letrozole
Pharmaceutical Form: Film-coated tablet
Product Name: Chemotherapy
Pharmaceutical Form:
INN or Proposed INN: Letrozole
Sponsors
CESAR Central European Society for
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the time to-progression (TTP) of therapy with Letrozole (arm A) with therapy with Letrozole in combination with standard chemotherapy (arm B).;Secondary Objective: Secondary objectives are • the comparisons of arm A with arm B with respect to the primary endpoint TTP separately in the subgroups of patients with - measurable disease and non-measurable disease / bone metastases only at entry - visceral and non-visceral disease at entry. • the comparisons of arm A with arm B with respect to: - quality-of-life (QoL) results , - objective response rate (ORR), - time-to- treatment-failure (TTF) - safety - overall survival (OS). ;Primary end point(s): The primary evaluation of the primary endpoint TTP will be the comparison of - chemotherapy given in combination with Letrozole (Arm B) versus Letrozole single agent (Arm A); This comparisons will be adjusted statistically for randomizing center, measurability/non-measurability of disease, and presence/absence of visceral lesions This designated primary confirmative evaluation of this study comprises a one-sided statistical hypothesis test on the significance level of 5% .The primary endpoint, TTP, will be statistically analyzed by the Cox proportional hazards regression method. The hazard ratio (HR), 95% confidence interval (CI) for the HR, and Chi-squared P-value derived from the Wald statistic will be reported. Median TTP with its 95% confidence interval and the 2 year survival rate with its 95% confidence interval will be estimated by the Kaplan-Meier product-limit method separately for each arm | — |
Countries
Austria, Czech Republic, Germany, Hungary, Slovenia
Outcome results
None listed