Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

February 18, 2022

Primary Completion Date

October 30, 2026

Study Completion Date

December 30, 2026

Conditions
Breast Cancer
Interventions
DRUG

Afuresertib

The starting doses of the combination therapy are afuresertib 125 mg PO, QD plus fulvestrant 500 mg IM, D1, 15 in the first cycle and afuresertib 125 mg PO, QD plus fulvestrant 500 mg IM, D1 Q4W in the subsequent cycles

DRUG

Afuresertib/placebo

afuresertib/placebo 125mg QD combined with fulvestrant 500mg Q4W (D1, 15 in cycle 1)

Trial Locations (55)

22031

RECRUITING

Virginia Cancer Specialists, Fairfax

30318

COMPLETED

Piedmont Cancer Institute, Atlanta

39216

COMPLETED

University of Mississippi Medical Center, Jackson

52242

COMPLETED

University of Iowa, Iowa City

90404

COMPLETED

Providence St. Johns Health Center, Santa Monica

100021

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

100142

RECRUITING

Beijing Cancer Hospital, Beijing

100730

RECRUITING

Peking Union Medical College Hospital (PUMCH), Beijing

110000

RECRUITING

Liaoning Cancer Hospital, Shenyang

110001

RECRUITING

The First Hospital of China Medical University, Shenyang

110004

RECRUITING

Shengjing Hospital of China Medical University, Shenyang

130000

RECRUITING

The first hospital of Jilin University, Changchun

130012

RECRUITING

Jilin Provincial Cancer Hospital, Changchun

150081

RECRUITING

Harbin Medical University Cancer Hospital, Harbin

200020

RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai

200032

RECRUITING

Zhongshan Hospital, Fudan University, Shanghai

210009

RECRUITING

Jiangsu Cancer Hospital, Nanjing

210029

RECRUITING

Jiangsu Provincial People's Hospital, Nanjing

215006

RECRUITING

The First Affiliated Hospital of Soochow University, Suzhou

225001

RECRUITING

Northern Jiangsu People's Hospital, Yangzhou

230031

RECRUITING

Anhui Provincial Cancer Hospital, Hefei

233004

RECRUITING

The First Affiliated Hospital of Bengbu Medical College, Bengbu

250117

RECRUITING

Shandong Cancer Hospital, Jinan

300060

RECRUITING

Tianjin Medical University Cancer Institute & Hospital, Tianjin

310003

RECRUITING

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

310016

RECRUITING

Sir-run shaw Hospital Zhejiang University of Medicine, Hangzhou

310022

RECRUITING

Zhejiang Cancer Hospital, Hangzhou

315040

RECRUITING

Ningbo Li Huili Hospital, Ningbo

317000

RECRUITING

Taizhou Hospital, Taizhou

350014

RECRUITING

Fujian Cancer Hospital, Fuzhou

400016

RECRUITING

The First Affiliated Hospital of Chongqing Medical University, Chongqing

400030

RECRUITING

Chongqing University Cancer Hospital, Chongqing

410013

RECRUITING

Hunan Cancer Hospital, Changsha

430022

RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

RECRUITING

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan

RECRUITING

Wuhan Central Hospital, Wuhan

430079

RECRUITING

Hubei Cancer Hospital, Wuhan

450008

RECRUITING

Henan Cancer Hospital, Zhengzhou

450052

RECRUITING

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

455000

RECRUITING

Anyang cancer hospital, Anyang

510000

RECRUITING

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

510050

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

528000

RECRUITING

The First People's Hospital of Foshan, Foshan

528403

RECRUITING

Zhongshan People's Hospital, Zhongshan

530021

RECRUITING

Guangxi Zhuang Autonomous Region People's Hospital, Nanning

RECRUITING

The First Affiliated Hospital of Guangxi Medical University, Nanning

610041

RECRUITING

Sichuan Cancer Hospital, Chengdu

RECRUITING

West China Hospital, Sichuan University, Chengdu

610072

RECRUITING

Sichuan Provincial People's Hospital, Chengdu

710061

RECRUITING

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

05401

COMPLETED

University of Vermont, Burlington

071000

RECRUITING

Affiliated Hospital of Hebei University, Baoding

050011

RECRUITING

The Fourth Hospital of Hebei Medical University, Shijiazhuang

063000

RECRUITING

Tangshan People's Hospital, Tangshan

Unknown

RECRUITING

Affiliated Hospital of Nantong University, Nantong

All Listed Sponsors
lead

Laekna Limited

INDUSTRY