Effects of Adjuvant Endocrine Therapy With Aromatase Inhibitors on the Postoperative Lipid Levels in Postmenopausal Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Ratio of patients whose low density lipoprotein-cholesterol（LDL-C） level ≥ 4.14 mmol/L in 2 years of administration among groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •The patients are not qualified to receive the adjuvant endocrine therapy with AIs.
- •The patients previously received other endocrine therapy (e.g. tamoxifen) simultaneity or the treatment with AIs (excluding those with a course of less than 3 months)
- •The patients received or are receiving the lipid-lowering therapy.
- •The patients suffer from other combined malignancy.
- •The patients have uncontrollable mental illness.
- •The patients experience severe cardiovascular diseases in the recent 6 months (e.g. unstable angina, chronic heart failure, uncontrollable hypertension >150/90 mmHg, myocardial infarction or cerebrovascular disorders).
排除标准
- 未提供
研究组 & 干预措施
steroidal aromatase inhibitors(AIs)
Exemestane 25mg Qd for 5 years
干预措施: Exemestane (Drug)
non-steroidal aromatase inhibitors(AIs)
Letrozole 2.5mg Qd or Anastrozole 1mg Qd for 5 years
干预措施: Letrozole (Drug)
non-steroidal aromatase inhibitors(AIs)
Letrozole 2.5mg Qd or Anastrozole 1mg Qd for 5 years
干预措施: Anastrozole (Drug)
结局指标
主要结局
Ratio of patients whose low density lipoprotein-cholesterol（LDL-C） level ≥ 4.14 mmol/L in 2 years of administration among groups
时间窗: Change of LDL-C level from Baseline to up to 2 years
次要结局
未报告次要终点
研究者
Peng Yuan
Principal Investigator
Chinese Academy of Medical Sciences