Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 75Years
FEMALE
NCT05860465

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

Led by Shanghai Pharmaceuticals Holding Co., Ltd · Updated on 2026-01-14

254

Participants Needed

22

Research Sites

172 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who voluntarily participate and sign informed consent
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Locally advanced or metastatic breast cancer not suitable for surgery or local therapies
  • At least one measurable tumor lesion
  • Laboratory results meeting organ function requirements
  • Agreement to use effective contraception
Not Eligible

You will not qualify if you...

  • Inflammatory breast cancer
  • Unsuitable for endocrine therapy as determined by the investigator
  • History of other cancers before study treatment
  • Known metastases to the central nervous system
  • Taking anti-tumor traditional Chinese patent medicines at consent
  • Surgery before study treatment without recovery from side effects
  • Participation in other investigational drug trials before study treatment
  • Pregnant or breastfeeding women
  • History of serious heart conditions or abnormal heart function
  • History of ischemic stroke or severe blood clots
  • Positive for hepatitis B or C with active infection or known HIV infection
  • History of severe allergies or allergy to study drug ingredients
  • Conditions affecting drug administration or absorption
  • Uncontrolled infections
  • History of drug abuse, heavy drinking, neurological or mental disorders
  • Other diseases posing excessive risk or making patients ineligible as per investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 22 locations

1

Affiliated Cancer Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510060

Actively Recruiting

2

Liuzhou people's Hospital

Liuzhou, Guangxi, China, 545026

Actively Recruiting

3

Anyang Cancer Hospital

Anyang, He'nan, China, 455001

Actively Recruiting

4

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, He'nan, China, 450052

Actively Recruiting

5

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050011

Actively Recruiting

6

Harbin Medical University cancer Hospital

Harbin, Heilongjiang, China, 150081

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7

Xiangyang Cancer Hospital

Wuhan, Hubei, China, 441021

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8

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China, 210009

Actively Recruiting

9

Jiangsu Province Hospital

Nanjing, Jiangsu, China, 210029

Actively Recruiting

10

Jilin Cancer Hospital

Changchun, Jilin, China, 130012

Actively Recruiting

11

The First Hospital of China Medical University

Shenyang, Liaoning, China, 110002

Actively Recruiting

12

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China, 750003

Actively Recruiting

13

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, China, 710061

Actively Recruiting

14

The second people's hospital of neijiang

Neijiang, Sichuan, China, 641199

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15

Yunnan Cancer Hospital

Kunming, Yunnan, China, 650118

Actively Recruiting

16

Zhejiang cancer Hospital

Hangzhou, Zhejiang, China, 310005

Actively Recruiting

17

Peking Union Medical College Hospital

Beijing, China, 100730

Actively Recruiting

18

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Actively Recruiting

19

Fujian Cancer Hospital

Fuzhou, China

Actively Recruiting

20

First Affiliated Hospital of Kunming Medical University

Kunming, China

Actively Recruiting

21

Shenzhen Hospital of University of Hong Kong

Shenzhen, China

Actively Recruiting

22

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Actively Recruiting

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Research Team

S

Shusen Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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