Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fulvestrant

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

GB491: The dose of GB491 is 150 mg, which should be taken with a meal and taken twice daily at approximately the same time each day, approximately 12 hours apart. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.

Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side.The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.

Placebo: The dose of placebo is 150 mg, which should be taken with a meal and taken twice daily at approximately the same time each day, approximately 12 hours apart. The placebo is administered according to the patient's dose group until the progression of disease occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.

Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.

GB491: The dose of GB491 is 150 mg, which should be taken with a meal and taken twice daily at approximately the same time each day, approximately 12 hours apart.

Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side.

GB491+ Fulvestrant

Placebo: The dose of Placebo is 150 mg, which should be taken with a meal and taken twice daily at approximately the same time each day, approximately 12 hours apart.

Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side.

Placebo+Fulvestrant

Shawn YU, MD

Tingjing Yao, Master

Changlu Hu, Ph.D

Zhendong Chen, Ph.D

Guangyu An, Ph.D

Binghe Xu, Ph.D

Weihong Zhao, Ph.D

Xiaohua Zeng, Ph.D

Hongyuan Li, Ph.D

Huawen Liu, Master

Chunsen Xu, Ph.D

Ru Zeng, Master

Danmei Pang, Ph.D

Shusen Wang, Ph.D

wangshs@sysucc.org.cn

Qianjun Chen, Ph.D

Liang Li, Bachelor

Haixia Wang, Ph.D

Cuiying Wang, Ph.D

Aimin Zang, Ph.D

Qingyuan Zhang, Ph.D

Hongqiang Guo, Ph.D

Yuanting Gu, Ph.D

Jing Cheng, Ph.D

Weiping Tao, Ph.D

Xinhong Wu, Ph.D

Ranhua Cao, Master

Zhengkui Sun, Ph.D

Ying Cheng, Ph.D

Jingwei Xu, Ph.D

Wei Li, Ph.D

Caigang Liu, Ph.D

Tao Sun, Ph.D

Xinlan Liu, Master

Meili Sun, Ph.D

Jing Liang, Ph.D

Weibo Wang, Ph.D

Lihua Song, Ph.D

Changping Shan, Ph.D

Yumin Yao, Ph.D

Wenfeng Li, Ph.D

Zhaofeng Zhu, Ph.D

Hongyan Jia, Ph.D

Xi Yan, Master

Zhongsheng Tong, Ph.D

Bing Zhao, Ph.D

Jianyun Nie, Ph.D

Fuming Qiu, Ph.D

Xiaojia Wang, Ph.D

Binghe Xu, PhD

GB491-004 is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of GB491 in combination with fulvestrant in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer who have progressed on prior endocrine therapy.

GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer

A Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial of GB491 Combined With Fulvestrant in Subjects With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed on Prior Endocrine Therapy

To assess the progression free survial (PFS), which is assessed by BICR.

To assess the progression free survial (PFS), which is assessed by PI.

To assess the objective response rate (ORR)

To assess the clinical benefit rate by BICR

To assess the incidence of SAE by Graded according to the National Cancer Institute (NCI CTCAE)

To assess the incidence of AE by Graded according to the National Cancer Institute (NCI CTCAE)

To assess the incidence of TEAE by Graded according to the National Cancer Institute (NCI CTCAE)

To evaluate the Cmax of GB491 and its metabolites G1T30

To evaluate the Tmax of GB491 and its metabolites G1T30

To evaluate the AUC of GB491 and its metabolites G1T30

Genor Biopharma Co., Ltd.

Spots Global Cancer Trial Database for placebo+fulvestrant