A randomized, multi-center Phase IIIb, open label, study of letrozole vs anastrozole in the adjuvant treatment of postmenopausal women with hormone receptor and node positive breast cancer

Conditions: Hormone receptor positive breast cancer in postmenopausal women
MedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2005-004263-35-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 4000

Inclusion Criteria

-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: 0
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

-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