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
- Conditions
- Este estudio es para evaluar el uso de letrozol frente a anastrozol en el tratamiento adyuvante en pacientes de elevado riesgo. La población en estudio son mujeres posmenopáusicas que recientemente hayan sufrido su primera cirugía de cáncer de mama y con afectación ganglionar y receptores hormonales. La primera cirugía puede haber sido una mastectomia total, una mastectomia parcial o una cuadrantectomia de su cáncer de mama primario.
- Registration Number
- EUCTR2005-004263-35-ES
- Lead Sponsor
- ovartis Farmacéutica SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 4032
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method