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This study is a prospective, controlled phase IV clinical trial among postmenopausal patients with hormone receptor-positive breast cancer.The main purpose is to compare the effects of steroidal aromatase inhibitor (AI) exemestane and non-steroidal AIs on the lipid levels of breast cancer patients.
Full description
The study subjects are composed of postmenopausal women with hormone receptor-positive breast cancer who have received exemestane, anastrozole or letrozole followed by testing of safety variables such as low-density lipoprotein- cholesterol (LDL-C), triglyceride(TC), total cholesterol, high-density lipoprotein cholesterol(HDL), blood calcium, transaminase and fasting plasma glucose at different time intervals in two years.
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Inclusion and exclusion criteria
Inclusion Criteria:
Pathologic analysis verifies to be early-stage invasive breast cancer while immunohistochemistry shows estrogen receptor(ER) and/or progesterone receptor(PR) positive (ER/PR positive is defined that >1% of cells are positive).
The patients have received surgery for breast cancer and recovered well for an interval of at least 1 week.
The patients have received post-operational adjuvant chemotherapy and/or adjuvant radiotherapy whereas the interval of chemotherapy and/or adjuvant radiotherapy is more than 2 weeks.
The postmenopausal women have been confirmed to be to menopausal as defined in NCCN guidelines(including post bilateral oophorectomy; age≥60 year-old; age≤60 year-old, menopause for more than 1 year and plasma Follicle-Stimulating Hormone (FSH) and estradiol levels meet the menopausal scope).
Do not receive concomitant endocrine therapy, e.g. drug-induced menopause, tamoxifen.
The patients do not have severe cardiopulmonary dysfunction.
ECOG score: 0-1
The patients have enough organ function and meet the scope of aromatase inhibitors(AIs) therapy. The laboratory test indexes must comply with the following requirements:
Blood routine: neutrophil≥1.5G/L, platelet count ≥75G/L, hemoglobin ≥100g/L Liver function: serum bilirubin ≤ 2 times the upper limit of normal value; ALT and AST≤3 times the upper limit of normal value; Renal function: serumcreatinine≤140μmol/L
Serum low density lipoprotein-cholesterol(LDL-C) value <3.37mmol/L
Imaging examination identifies none of local recurrence or distal metastasis.
No other combined malignancy.
The patients have good compliance to the therapy and follow-up to be scheduled and are able to understand the study protocol and sign the Informed Consent Form.
Exclusion criteria
500 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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