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RECRUITING
NCT05860465
PHASE2/PHASE3

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer

Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

View on ClinicalTrials.gov

Summary

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.

Official title: A Phase II/III Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4/6 Inhibitor Combined With Endocrine Therapy

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

254

Start Date

2023-09-08

Completion Date

2026-12-30

Last Updated

2026-01-14

Healthy Volunteers

No

Interventions

DRUG

SPH4336 Tablets

SPH4336 Tablets :Administered by oral; Letrozole tablets:Administered by oral; Fulvestrant injection:Administered by intravenous infusion

DRUG

SPH4336 Tablets Placebo

SPH4336 Tablets Placebo :Administered by oral; Letrozole tablets:Administered by oral; Fulvestrant injection:Administered by intravenous infusion

Locations (22)

Affiliated Cancer Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Liuzhou people's Hospital

Liuchow, Guangxi, China

Anyang Cancer Hospital

Anyang, He'nan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, He'nan, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University cancer Hospital

Harbin, Heilongjiang, China

Xiangyang Cancer Hospital

Wuhan, Hubei, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, China

The second people's hospital of neijiang

Neijiang, Sichuan, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Zhejiang cancer Hospital

Hangzhou, Zhejiang, China

Peking Union Medical College Hospital

Beijing, China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Fujian Cancer Hospital

Fuzhou, China

First Affiliated Hospital of Kunming Medical University

Kunming, China

Shenzhen Hospital of University of Hong Kong

Shenzhen, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China