Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

374

Participants

Timeline

Start Date

April 24, 2023

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2026

Conditions
Locally Advanced or Metastatic Breast Cancer
Interventions
DRUG

SPH4336 Tablets 400mg

"SPH4336 Tablets :Orally, 400mg once a day; 28 days/cycle~Letrozole tablets :Orally, 2.5mg once a day; 28 days/cycle"

DRUG

SPH4336 Tablets Placebo

"SPH4336 Tablets Placebo:Orally,28 days/cycle~Letrozole tablets :Orally, 2.5mg once a day; 28 days/cycle"

Trial Locations (9)

100142

RECRUITING

Peking University Cancer Hospital, Beijing

130022

RECRUITING

The Second Norman Bethune Hospital of Jilin Univer, Changchun

337099

RECRUITING

Pingxiang People's Hospital, Pingxiang

350014

RECRUITING

Fujian Cancer Hospital, Fuzhou

450052

RECRUITING

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

455001

RECRUITING

AnYang Tumor Hospital, Anyang

510060

RECRUITING

Affiliated Cancer Hospital, Sun Yat-sen University, Guangzhou

550000

RECRUITING

The Affiliated Cancer Hospital of Guizhou Medical University, Guiyang

750003

RECRUITING

General Hospital of Ningxia Medical University, Yinchuan

All Listed Sponsors
lead

Shanghai Pharmaceuticals Holding Co., Ltd

INDUSTRY