[LY01005和Zoladex®在绝经前乳腺癌患者中进行的III期多中心随机比较研究]
X Y Shao1, Q Y Zhang2, Z F Niu3
1Department of Breast Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China.
Zhonghua zhong liu za zhi [Chinese journal of oncology]
|April 23, 2025
概括
LY01005在维持绝经期前乳腺癌患者的绝经期水平方面表现出与Zoladex®无差的疗效. 这两种性腺激素释放激素 (GnRH) 激动剂在这个中国队列中表现出相似的安全性.
科学领域:
- 在瘤学瘤学.
- 内分泌学 在内分泌学.
背景情况:
- 绝经前乳腺癌的治疗往往包括抑制卵巢功能.
- 激素释放激素 (GnRH) 激动剂是诱导可逆更年期的关键药物.
研究的目的:
- 为了比较每月使用的GnRH激动剂LY01005与Zoladex®的疗效和安全性.
- 为了评估 LY01005 的药理动力学和药理动力学特性.
主要方法:
- 一项随机试验,涉及188名中国绝经前乳腺癌患者.
- 每月注射LY01005或Zoladex®三次循环,结合泰莫西芬.
- 主要终点:从第29天到第85天保持雌激醇 (E2) 的累积概率≤30 pg/ml.
主要成果:
- LY01005实现了93.1%的维持更年期E2水平的概率,而Zoladex® (非劣质) 的概率为86.3%.
- 这两种治疗都显示了E2的同等抑制,黄素化激素 (LH) 和卵泡刺激激素 (FSH) 从基线.
- LY01005表现出LH和FSH的暂时初始增加,随后持续抑制.
结论:
- LY01005在绝经前乳腺癌的卵巢抑制方面有效且与Zoladex®不逊色.
- LY01005具有与Zoladex®相似的安全性,支持其在该患者群体中的使用.
更多相关视频
07:25A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
Published on: March 6, 2018
12.9K
00:04A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
10.6K
相关概念视频
Treatment Resistant Cancers
2.7K
Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
2.7K
Clinical Trials
8.5K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
8.5K
Clinical Trials: Overview
4.7K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.7K
