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Fulvestrant

Exemestane

Letrozole

SPH4336 Tablets; Letrozole tablets; Fulvestrant; Exemestane

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

SPH4336 Tablets

Shusen Wang

Yueyin Pan

Yingying Du

Bin Yu

Cuizhi Geng

Qingyuan Zhang

Jing Sun

Xinshuai Wang

Yuehua Wang

Yongmei Yin

Ying Cheng

Jiuwei Cui

Xinlan Liu

Xujuan Wang

Bing Zhaoi

Zhanhong Chen

Chunmei Bai

Gongsheng Jin

Chao Deng

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases.

Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.

A Phase II Study of SPH4336 in Combination With Endocrine Therapy in HR-positive, HER2-negative Breast Cancer Patients With Brain Metastases.

Objective response rate according to response assessment in neuro-oncology-brain metastases (RANO-BM) criteria.

DoR is measured from the date of first evidence of a confirmed response (CR or PR), as defined by RANO-BM, to the date objective progression or death from any cause.

Percentage of participants with BOIR of CR, PR, or SD: IDCR, as defined by RANO-BM is reported.

Determination of the overall survival times of all patients.

Adverse event type, incidence, correlation with study drug

Shanghai Pharmaceuticals Holding Co., Ltd

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

SPH4336 Tablets Placebo

Jifeng Feng

Yue'e Teng

Jin Yang

Jianyun Nie

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.	NCT05872347	Breast Cancer B...	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

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