A Prospective Cohort Study of Serum Estradiol (E2) Levels in Breast Cancer Patients During Endocrine Therapy by High Performance Liquid Chromatography-tandem Mass Spectrometry (LC-MS /MS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- The serum E2 levels in breast cancer patients during endocrine therapy.
研究概览
简要总结
The investigators intend to conduct a prospective cohort study to detect E2 levels during endocrine therapy in Chinese breast cancer patients using LC-MS/MS methods, and to determine the proportion of patients with premenopausal E2 levels (OFR or E2 insufficiency) during AIs or FUL endocrine therapy. To further explore the correlation between serum E2 levels and the efficacy of endocrine therapy in Chinese patients, so as to ensure the safety and efficacy of endocrine therapy for patients, and pave the way for further providing more accurate individualized treatment programs.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old;
- •Histologically confirmed breast cancer;
- •Patients with early breast cancer (including natural menopause and artificial menopause using LHRHa), or patients with advanced breast cancer (including natural menopause and artificial menopause using LHRHa) who use AIs (letrozole, anastrozole or exemestane) as adjuvant endocrine therapy, First-line CDK4/6 inhibitors (Palbociclib, Dalpiciclib, Abemaciclib or Ribociclib) +AI endocrine therapy, second-line CDK4/6 inhibitors (Palbociclib, Dalpiciclib, Abemaciclib or Ribociclib) + fluvestrant (FUL) endocrine therapy;
- •Patients with needs for hormone testing;
- •Standard treatment, complete clinical data, including complete efficacy evaluation and follow-up data.
排除标准
- •Breast cancer patients using TAM endocrine therapy;
- •In advanced patients, AIs exceeded first-line use (that is, in advanced disease, one endocrine therapy regimen had been used and failed), and FUL exceeded second-line use (that is, more than one endocrine therapy regimen had been used and failed)
研究组 & 干预措施
AI
Patients with AIs
干预措施: AIs (Drug)
OFS+AI
Patients with OFS+AIs
干预措施: OFS+AIs (Drug)
FUL
Patients with FUL
干预措施: FUL (Drug)
结局指标
主要结局
The serum E2 levels in breast cancer patients during endocrine therapy.
时间窗: From enrollment to 1 months
Consistency between 2 methods
次要结局
未报告次要终点
研究者
Cong Xue
Clinical Professor
Sun Yat-sen University