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Breast Diseases

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Letrozole

SPH4336 Tablets ：Orally, 400mg once a day; 28 days/cycle

Letrozole tablets ：Orally, 2.5mg once a day; 28 days/cycle

SPH4336 Tablets 400mg

SPH4336 Tablets Placebo：Orally,28 days/cycle

Letrozole tablets ：Orally, 2.5mg once a day; 28 days/cycle

SPH4336 Tablets Placebo

Shusen Wang

Jian Liu

Zhihong Wang

Jing Sun

Xinshuai Wang

Feng Yao

Zhixiang Zhuang

An Xiao

Jingwei Xu

Xinlan Liu

Baojiang Li

Huiping Li

Weipeng Zhao

This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer

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

Randomized, Double-blind, Placebo-controlled, Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.

from the start date of study treatment to the date of progression disease or death , whichever occurred first.

DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.

DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause.

Determination of the overall survival times of all patients.

Shanghai Pharmaceuticals Holding Co., Ltd

Fulvestrant

SPH4336 Tablets; Letrozole tablets; Fulvestrant injection

SPH4336 Tablets Placebo; Letrozole tablets; Fulvestrant injection

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

SPH4336 Tablets

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

Bin Yu

Cuizhi Geng

Qingyuan Zhang

Yuehua Wang

Jifeng Feng

Yongmei Yin

Ying Cheng

Yue'e Teng

Jin Yang

Xujuan Wang

Jianyun Nie

Zhanhong Chen

Chunmei Bai

Jun Qian

Weiwei Huang

Jinxian Qian

Haiman Jing

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.

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

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

DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease

DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause

Determination of the overall survival times of all patients

Adverse event type, incidence, duration, correlation with study drug

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer	NCT05744687	Locally Advance...	SPH4336 Tablets... SPH4336 Tablets...	18 Years - 75 Years	Shanghai Pharmaceuticals Holding Co., Ltd
Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer	NCT05860465	Locally Advance...	SPH4336 Tablets SPH4336 Tablets...	18 Years - 75 Years	Shanghai Pharmaceuticals Holding Co., Ltd

Spots Global Cancer Trial Database for sph4336 tablets placebo