To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

432

Participants

Timeline

Start Date

July 1, 2022

Primary Completion Date

July 2, 2025

Study Completion Date

June 30, 2026

Conditions
HR-positive, HER2-negative Breast Neoplasms
Interventions
DRUG

TQB3616 capsule

TQB3616 capsule is a CDK (cyclin-dependent kinases) 4/6 kinase inhibitor, which can selectively inhibit THE activity of CDK4/6 kinase, make it form a complex with Cyclin D, reduce the phosphorylation level of retinoblastoma protein (Rb) in cancer cells, and prevent cells from entering S phase from G1 phase

DRUG

Placebo

It is a placebo

DRUG

Fulvestrant injection

Fulvestrant is a competitive estrogen receptor antagonist, and its mechanism is related to the down-regulation of estrogen receptor (ER) protein level

Trial Locations (88)

45008

Henan Cancer Hospital, Zhengzhou

100034

Peking University First Hospital, Beijing

100142

Beijing Cancer Hospital, Beijing

110002

The First Affiliated Hospital of China Medical University, Shenyang

110042

Liaoning Cancer Hospital & Institute, Shenyang

116000

The Second Hosptial of DaLian Medical University, Dalian

116001

Affiliated Zhongshan Hospital of Dalian University, Dalian

121012

The First Affiliated Hospital of Jinzhou Medical University, Jinzhou

130012

Jilin Cancer Hospital, Changchun

130021

The First Hospital of Jilin University, Changchun

130041

Second Hospital of Jilin University, Changchun

150081

Affiliated Cancer Hospital of Harbin Medical University, Harbin

150086

The Second Affiliated Hospital of Harbin Medical University, Harbin

154007

Jiamusi Cancer Hospital, Jiamusi

200040

Huadong Hospital, Shanghai

200123

Shanghai Oriental Hospital, Shanghai

200433

Shanghai Changhai Hospital, Shanghai

210008

Nanjing Drum Tower Hospital, Nanjing

210029

Jiangsu province hospital, Nanjing

213000

Changzhou Cancer Hospital, Changzhou

221004

The Affiliated Hospital of Xuzhou Medical University, Xuzhou

223300

Huai'an First People's Hospital, Huai'an

226001

Affiliated Hospital of Nantong University, Nantong

233099

The First Affiliated Hospital of Bengbu Medical College, Bengbu

241000

The First Affiliated Hospital of Wannan Medical College, Wuhu

250117

Shandong Cancer Hospital, Jinan

255020

Zibo Central Hospital, Zibo

256699

Binzhou Medical College Affiliated Hospital, Binzhou

261000

Weifang Hospital of Traditional Chinese Midicine, Weifang

264008

Yantai Yantai Mountain hospital, Yantai

266071

Qingdao University Affiliated Hospital, Qingdao

272000

Affiliated Hospital of Jining Medical University, Jining

276000

Linyin Cancer Hospital, Linyi

300060

Tianjin Medical University Cancer Hospital, Tianjin

300308

Tianjin Medical University Cancer Hospital Konggang Hospital, Tianjin

310006

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medcine, Hangzhou

310009

The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

330000

The Third Hospital of Nanchang, Nanchang

341099

The First Affiliated Hospital of Gannan Medical University, Ganzhou

350014

Fujian Provincial Cancer Hospital, Fuzhou

400000

Chongqing University Cancer Hospital, Chongqing

400083

The Southwest Hospital of AMU, Chongqing

410000

The Second Xiangya Hospital of Central South University, Changsha

Xiangya Hospital of Central South University, Changsha

410031

Hunan Cancer Hospital, Changsha

415003

The First People's Hospital of Changde, Changde

443003

Yichang Central People's Hospital, Yichang

450052

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

471003

Luoyang Central Hospital, Luoyang

473000

Nanyang Central Hospital, Nanyang

510060

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

510080

Nanfang Hospital Southern Medical University, Guangzhou

510630

The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou

512025

Yue Bei People's Hospital, Shaoguan

518020

ShenZhen People's Hospital, Shenzhen

518036

PeKing University ShenZhen Hosipital, Shenzhen

519099

The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai

522095

Jieyang People's Hospital, Jieyang

525000

Maoming people's hospital, Maoming

528403

Zhongshan City People's Hospital, Zhongshan

537000

Yulin First People's Hospital, Yulin

541199

The Second Affiliated Hospital of Guilin Medical University, Guilin

610083

Chinese People's Liberation Army Western Theater General Hospital, Chengdu

629000

Suining Central Hospital, Suining

646000

The Affiliated Hospital of Southwest Medical University, Luzhou

650106

Yunnan Cancel Hospital, Kunming

710000

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

710032

First Affiliated University Hospital of PLA Air Force Military Medical, Xi'an

710038

Second Affiliated Hospital of PLA Air Force Military Medical, Xi'an

710100

Xi'an International Medical Center Hospital, Xi'an

730000

Gansu Provincial Cancer Hospital, Lanzhou

Gansu Wuwei Tumour Hospital, Wuwei

730030

Lanzhou University Second Hospital, Lanzhou

750003

General Hospital of Ningxia Medical, Yinchuan

810000

Qinghai University affiliated hospital, Xining

830011

Cancer Hospital affiliated to Xinjiang Medical University, Ürümqi

071000

The Affiliated Hospital of Hebei University, Baoding

061013

Cangzhou Central Hospital, Cangzhou

Hebei Cangzhou Hospital of Integrated Traditional Chinese, Cangzhou

067020

Affiliated Hospital of Chengde Medical University, Chengde

065000

Hebei Petro China Central Hospital, Langfang

050011

The Fourth Hospital of Hebei Medical University, Shijiazhuang

024005

Affiliated Hospital of Chifeng University, Chifeng

010000

Inner Mongolia Autonomous Region Cancer Hospital, Hohhot

The Affilliate Hospital of Inner Mongolia Medical Univercity, Hohhot

046000

Changzhi People's Hospital, Changzhi

030013

Shanxi Cancer Hospital, Taiyuan

All Listed Sponsors
lead

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY