Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 75Years
FEMALE
NCT05744687

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

Led by Shanghai Pharmaceuticals Holding Co., Ltd · Updated on 2025-08-17

374

Participants Needed

9

Research Sites

161 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of 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.
Not Eligible

You will not qualify if you...

  • Prior treatment with any CDK4/6 inhibitor.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Fujian Cancer Hospital

Fuzhou, Fujian, China, 350014

Actively Recruiting

2

Affiliated Cancer Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510060

Actively Recruiting

3

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China, 550000

Actively Recruiting

4

AnYang Tumor Hospital

Anyang, Henan, China, 455001

Actively Recruiting

5

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China, 450052

Actively Recruiting

6

Pingxiang People's Hospital

Pingxiang, Jiangxi, China, 337099

Actively Recruiting

7

The Second Norman Bethune Hospital of Jilin Univer

Changchun, Jilin, China, 130022

Actively Recruiting

8

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China, 750003

Actively Recruiting

9

Peking University Cancer Hospital

Beijing, China, 100142

Actively Recruiting

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Research Team

S

Shusen Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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