LY01005和诺雷得®治疗绝经前乳腺癌的多中心随机对照Ⅲ期临床研究

Xiying Shao; Qingyuan Zhang; Zhaofeng Niu; Man Li; Jingfen Wang; Zhanhong Chen; Ruizhen Luo; Guangdong Qiao; Jianguo Wang; Liyuan Qian; Ronghua Yang; Zhendong Chen; Jian Wang; Yumin Yao; Jianghua Ou; Tao Sun; Qiao Cheng; Yongsheng Wang; Jian Huang; Hongying Zhao; Wuyun Su; Zhong Ouyang; Yu Ding; Lilin Chen; Sumei Yang; Mengsheng Cui; Aimin Zang; Enxiang Zhou; Peizhi Fan; Jing Zhang; Qiang Liu; Yuee Teng; Hui Li; Jianyun Nie; Jin Yang; Xiaojia Wang; Zefei Jiang

doi:10.3760/cma.j.cn112152-20240126-00051

LY01005和诺雷得^®治疗绝经前乳腺癌的多中心随机对照Ⅲ期临床研究

Translated title of the contribution: Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex^® for patients with premenopausal breast cancer

Xiying Shao
, Qingyuan Zhang
, Zhaofeng Niu
, Man Li
, Jingfen Wang
, Zhanhong Chen
, Ruizhen Luo
, Guangdong Qiao
, Jianguo Wang
, Liyuan Qian
, Ronghua Yang
, Zhendong Chen
, Jian Wang
, Yumin Yao
, Jianghua Ou
, Tao Sun
, Qiao Cheng
, Yongsheng Wang
, Jian Huang
, Hongying Zhao

Wuyun Su, Zhong Ouyang, Yu Ding, Lilin Chen, Sumei Yang, Mengsheng Cui, Aimin Zang, Enxiang Zhou, Peizhi Fan, Jing Zhang, Qiang Liu, Yuee Teng, Hui Li, Jianyun Nie, Jin Yang, Xiaojia Wang, Zefei Jiang

Zhejiang Cancer Hospital
Harbin Medical University
Yuncheng Central Hospital
Dalian Medical University
Linyi Cancer Hospital
Cangzhou Hospital of Integrated TCM-WM
Yantai Yuhuangding Hospital
Xiangtan Central Hospital
Central South University
Changzhou Cancer Hospital
Anhui Medical University
Weihai Maternal and Child Health Hospital
Liaocheng People's Hospital
Xinjiang Medical University
Liaoning Tumor Hospital & Institute
First Affiliated Hospital of Chongqing Medical University
Shandong Cancer Hospital
Xuzhou Cancer Hospital
Affiliated Hospital of Inner Mongolia Medical University
The First Affiliated Hospital of Xiamen University
Zibo Central Hospital
Zhongshan Hospital Affiliated to Xiamen University
Changzhi Medical College
Hebei University
Hunan Normal University
Hebei General Hospital
Sun Yat-Sen University
China Medical University
Sichuan Cancer Hospital and Institute
Yunnan Cancer Hospital
The First Affiliated Hospital of Xi’an Jiaotong University
General Hospital of People's Liberation Army

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

Abstract

Background To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex^® in Chinese patients with premenopausal breast cancer. Methods From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex^® every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex^®. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex^®. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex^® group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion LY01005 is as effective as Zoladex^® in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

Translated title of the contribution	Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex^® for patients with premenopausal breast cancer
Original language	Chinese (Traditional)
Pages (from-to)	340-348
Number of pages	9
Journal	Zhonghua zhong liu za zhi [Chinese journal of oncology]
Volume	47
Issue number	4
DOIs	https://doi.org/10.3760/cma.j.cn112152-20240126-00051
State	Published - 23 Apr 2025
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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10.3760/cma.j.cn112152-20240126-00051

Cite this

Shao, X., Zhang, Q., Niu, Z., Li, M., Wang, J., Chen, Z., Luo, R., Qiao, G., Wang, J., Qian, L., Yang, R., Chen, Z., Wang, J., Yao, Y., Ou, J., Sun, T., Cheng, Q., Wang, Y., Huang, J., ... Jiang, Z. (2025). LY01005和诺雷得^®治疗绝经前乳腺癌的多中心随机对照Ⅲ期临床研究. Zhonghua zhong liu za zhi [Chinese journal of oncology], 47(4), 340-348. https://doi.org/10.3760/cma.j.cn112152-20240126-00051

@article{7703e8e1f4eb4445b0c1a780390b6717,

title = "LY01005和诺雷得{\textregistered}治疗绝经前乳腺癌的多中心随机对照Ⅲ期临床研究",

abstract = "Background To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex{\textregistered} in Chinese patients with premenopausal breast cancer. Methods From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex{\textregistered} every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex{\textregistered}. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1\% for LY01005 and 86.3\% for Zoladex{\textregistered}. The between-group difference was 6.8\% (95\% CI: -2.3\%, 15.9\%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex{\textregistered} group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34\% to 90.23\% vs. 82.11\% to 85.02\%; LH: 88.89\% to 95.52\% vs. 89.70\% to 97.02\%; FSH: 75.36\% to 80.85\% vs.73.07\% to 80.24\%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion LY01005 is as effective as Zoladex{\textregistered} in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.",

keywords = "Breast neoplasms, Efficacy, GnRH agonists, LY01005, Pharmacodynamics, Pharmacokinetics, Safety, Zoladex",

author = "Xiying Shao and Qingyuan Zhang and Zhaofeng Niu and Man Li and Jingfen Wang and Zhanhong Chen and Ruizhen Luo and Guangdong Qiao and Jianguo Wang and Liyuan Qian and Ronghua Yang and Zhendong Chen and Jian Wang and Yumin Yao and Jianghua Ou and Tao Sun and Qiao Cheng and Yongsheng Wang and Jian Huang and Hongying Zhao and Wuyun Su and Zhong Ouyang and Yu Ding and Lilin Chen and Sumei Yang and Mengsheng Cui and Aimin Zang and Enxiang Zhou and Peizhi Fan and Jing Zhang and Qiang Liu and Yuee Teng and Hui Li and Jianyun Nie and Jin Yang and Xiaojia Wang and Zefei Jiang",

year = "2025",

month = apr,

day = "23",

doi = "10.3760/cma.j.cn112152-20240126-00051",

language = "繁体中文",

volume = "47",

pages = "340--348",

journal = "Zhonghua zhong liu za zhi [Chinese journal of oncology]",

issn = "0253-3766",

publisher = "Chinese Medical Journals Publishing House Co.Ltd",

number = "4",

}

Shao, X, Zhang, Q, Niu, Z, Li, M, Wang, J, Chen, Z, Luo, R, Qiao, G, Wang, J, Qian, L, Yang, R, Chen, Z, Wang, J, Yao, Y, Ou, J, Sun, T, Cheng, Q, Wang, Y, Huang, J, Zhao, H, Su, W, Ouyang, Z, Ding, Y, Chen, L, Yang, S, Cui, M, Zang, A, Zhou, E, Fan, P, Zhang, J, Liu, Q, Teng, Y, Li, H, Nie, J, Yang, J, Wang, X & Jiang, Z 2025, 'LY01005和诺雷得^®治疗绝经前乳腺癌的多中心随机对照Ⅲ期临床研究', Zhonghua zhong liu za zhi [Chinese journal of oncology], vol. 47, no. 4, pp. 340-348. https://doi.org/10.3760/cma.j.cn112152-20240126-00051

TY - JOUR

T1 - LY01005和诺雷得®治疗绝经前乳腺癌的多中心随机对照Ⅲ期临床研究

AU - Shao, Xiying

AU - Zhang, Qingyuan

AU - Niu, Zhaofeng

AU - Li, Man

AU - Wang, Jingfen

AU - Chen, Zhanhong

AU - Luo, Ruizhen

AU - Qiao, Guangdong

AU - Wang, Jianguo

AU - Qian, Liyuan

AU - Yang, Ronghua

AU - Chen, Zhendong

AU - Wang, Jian

AU - Yao, Yumin

AU - Ou, Jianghua

AU - Sun, Tao

AU - Cheng, Qiao

AU - Wang, Yongsheng

AU - Huang, Jian

AU - Zhao, Hongying

AU - Su, Wuyun

AU - Ouyang, Zhong

AU - Ding, Yu

AU - Chen, Lilin

AU - Yang, Sumei

AU - Cui, Mengsheng

AU - Zang, Aimin

AU - Zhou, Enxiang

AU - Fan, Peizhi

AU - Zhang, Jing

AU - Liu, Qiang

AU - Teng, Yuee

AU - Li, Hui

AU - Nie, Jianyun

AU - Yang, Jin

AU - Wang, Xiaojia

AU - Jiang, Zefei

PY - 2025/4/23

Y1 - 2025/4/23

N2 - Background To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex® in Chinese patients with premenopausal breast cancer. Methods From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex® every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex®. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex®. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex® group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion LY01005 is as effective as Zoladex® in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

AB - Background To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex® in Chinese patients with premenopausal breast cancer. Methods From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex® every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex®. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex®. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex® group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion LY01005 is as effective as Zoladex® in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

KW - Breast neoplasms

KW - Efficacy

KW - GnRH agonists

KW - LY01005

KW - Pharmacodynamics

KW - Pharmacokinetics

KW - Safety

KW - Zoladex

UR - https://www.scopus.com/pages/publications/105003585456

U2 - 10.3760/cma.j.cn112152-20240126-00051

DO - 10.3760/cma.j.cn112152-20240126-00051

M3 - 文章

C2 - 40268551

AN - SCOPUS:105003585456

SN - 0253-3766

VL - 47

SP - 340

EP - 348

JO - Zhonghua zhong liu za zhi [Chinese journal of oncology]

JF - Zhonghua zhong liu za zhi [Chinese journal of oncology]

IS - 4

ER -

LY01005和诺雷得^®治疗绝经前乳腺癌的多中心随机对照Ⅲ期临床研究

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