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 cancer - N/A
- Conditions
- This study will be a head to head comparison of letrozole versus anastrozole in the adjuvant treatment of high risk patients. Post-menopausal patients who recently have undergone their primary surgery for their breast cancer are targeted patient population. They must also have hormone positive disease and have lymph node positive disease. The primary surgery could have been a total mastectomy, lumpectomy or quadrantectomy for primary breast cancer.
- Registration Number
- EUCTR2005-004263-35-DE
- Lead Sponsor
- ovartis Pharma Services AG
- 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:
• 12 weeks from completion of surgery or 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.
• Previous diagnosis of metachronous 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