Leuplin SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 651
- 主要终点
- Number of Participants Reporting One or More Adverse Drug Reactions
研究概览
简要总结
The purpose of this survey is to examine the safety and efficacy of long-term use (96 weeks) of leuprorelin acetate SR (slow release) 11.25 milligram (mg) for injection (Leuplin SR 11.25 mg for Injection) in premenopausal breast cancer patients in daily medical practice, as well as to examine factors that can influence the safety and efficacy of treatment with leuprorelin acetate SR 11.25 mg for injection (Leuplin SR 11.25 mg for Injection).
详细描述
This survey was designed to examine the safety and efficacy of long-term use (96 weeks) of leuprorelin acetate 3 months depot for injection (Leuplin SR 11.25 mg for Injection) in premenopausal breast cancer patients in daily medical practice, as well as to examine factors that can influence the safety and efficacy of treatment with leuprorelin acetate SR 11.25 mg for injection (Leuplin SR 11.25 mg for Injection).
For adults, 11.25 mg of leuprorelin acetate is usually administered subcutaneously once every 12 weeks. Prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. The powder is then fully suspended in the fluid while ensuring that bubbles are not generated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal breast cancer patients (patients with advanced or recurrent breast cancer and patients who received adjuvant therapy).
排除标准
- •Patients with a history of treatment with Leuplin SR 11.25 mg for Injection
研究组 & 干预措施
leuprorelin acetate
Subcutaneous administration of leuprorelin acetate once every 12 weeks
干预措施: Leuprorelin acetate (Drug)
结局指标
主要结局
Number of Participants Reporting One or More Adverse Drug Reactions
时间窗: Baseline up to 96 weeks
Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Number of Participants Reporting One or More Serious Adverse Drug Reactions
时间窗: Baseline up to 96 weeks
Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The event occurred was breast cancer female
次要结局
- Percentage of Participants With Advanced or Recurrent Breast Cancer (Best Response)(Week 24, 48,96)
- Percentage of Participants With Progression Free Survival(Baseline up to 96 weeks)
- Percentage of Participants With Recurrence-free Survival Who Were Treated With the Drug as Adjuvant Therapy(Baseline up to 96 weeks)