A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer

PHASE3UnknownINTERVENTIONAL
Enrollment

274

Participants

Timeline

Start Date

May 25, 2022

Primary Completion Date

December 31, 2023

Study Completion Date

July 31, 2025

Conditions
Breast Cancer
Interventions
DRUG

BPI-16350

BPI-16350 400 mg, orally once daily

DRUG

placebo

Placebo 400 mg, orally once daily

DRUG

Fulvestrant

Fulvestrant 500 mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle until progressive disease

Trial Locations (64)

100012

The First Hospital of China Medical University, Shenyang

100039

The First Medical Center of the PLA General Hospital, Beijing

The Seventh Medical Center of the PLA General Hospital, Beijing

100044

The First Affiliated Hospital of Gannan Medical College, Ganzhou

110004

Shengjing Hospital of China Medical University, Shenyang

110801

Liaoning Cancer Hospital & Institute, Shenyang

116023

The Second Affiliated Hospital of Dalian Medical University, Dalian

130012

Jilin Cancer Hospital, Changchun

130041

The Second Hospital of Jilin University, Changchun

132011

Jilin Hospital of Chinese Literature, Siping

150081

Harbin Medical University Cancer Hospital, Harbin

200032

Fudan University Shanghai Cancer Center, Shanghai

210009

Jiangsu Cancer Hospital, Nanjing

215004

The Second Affiliated Hospital of Soochow University, Suzhou

221009

Xuzhou Central Hospital, Xuzhou

230002

Anhui Provincial Hospital, Hefei

230022

The First Affiliated Hospital of Anhui Medical University, Hefei

233099

The First Affiliated Hospital of Bengbu Medical College, Bengbu

250117

Shandong Cancer Hospital, Jinan

261000

Weifang People's Hospital, Weifang

264299

Weihai Municipal Hospital, Weihai

266003

The Affiliated Hospital of Qingdao University, Qingdao

272007

Affiliated Hospital of Jining Medical University, Jining

276002

Linyi Cancer Hospital, Linyi

300181

Tianjin Cancer Hospital, Tianjin

310003

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

310014

Zhejiang Provincial People's Hospital, Hangzhou

330006

The First Affiliated Hospital of Nanchang University, Nanchang

330008

The Third Hospital of Nanchang, Nanchang

350001

Fujian Medical University Union Hospital, Fuzhou

350014

Fujian Cancer Hospital, Fuzhou

361003

The First Affiliated Hospital of Xiamen University, Ximen

400030

Chongqing University Three Gorges Hospital, Chongqing

410031

Hunan Cancer Hospital, Changsha

412007

Zhuzhou Central Hospital, Zhuzhou

415003

The First People's Hospital Of Changde City, Changde

417099

Loudi Central Hospital, Loudi

421001

The First Affiliated Hospital of Nanhua University, Hengyang

Inner Mongolia People's Hospital, Hohhot

422000

Shaoyang Central Hospital, Shaoyang

423099

Chenzhou First People's Hospital, Chenzhou

425002

Yongzhou Central Hospital, Yongzhou

430014

The Central Hospital of Wuhan, Wuhan

430050

Fifth Hospital in WuHan, Wuhan

430060

Renmin Hospital of Wuhan University, Wuhan

430079

Hubei Cancer Hospital, Wuhan

443008

Yichang Central People's Hospital, Yichang

450052

The First Affiliated Hospital of Henan University of Science and Technology, Luoyang

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

455001

Anyang Cancer Hospital, Anyang

473007

The first Affiliated Hospital of Nanyang Medical College, Nanyang

510000

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

510060

Sun Yat-Sen University Cancer Hospital, Guangzhou

515041

Cancer Hospital of Shantou University Medical College, Shantou

530021

The First Affiliated Hospital of Guangxi Medical University, Nanning

610042

Sichuan Cancer Hospital&Institute, Chengdu

610051

The Sixth People's Hospital of Chengdu, Chengdu

650118

Yunnan Cancer Hospital, Kunming

730013

The First Hospital of Lanzhou University, Lanzhou

830000

Cancer Hospital of Xinjiang Medical University, Ürümqi

061012

Cangzhou Hospital of Integrated TCM-WM·Hebei, Cangzhou

067020

Affiliated Hospital of Chengde Medical University, Chengde

063001

Tangshan People's Hospital, Tangshan

054001

Xingtai People's Hospital, Xingtai

All Listed Sponsors
lead

Betta Pharmaceuticals Co., Ltd.

INDUSTRY