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A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.

NCT07207070 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2025-12-30

No results posted yet for this study

Summary

This study is a randomised, open-label, multicentre phase III clinical study evaluating the efficacy and safety of JS105 combined with Dalpiciclib and Fulvestrant compared with Dalpiciclib and Fulvestrant in patients with PIK3CA-mutated, HR-positive, HER2-negative recurrent or metastatic breast cancer.

Conditions

Interventions

DRUG

JS105

Patients will receive oral JS105 on Days 1-28 of each 4-week cycle.

DRUG

Dalpiciclib

Patients will receive oral Dalpiciclib for 3 weeks, followed by 1 week off in each 4-week cycle；

DRUG

Fulvestrant 50 Mg/mL Intramuscular Solution

Patients will receive intramuscular Fulvestrant on day 1 and day 15 of the first cycle and then on day 1 of each subsequent 4-week cycle.

Sponsors & Collaborators

  • Risen (Suzhou) Pharma Tech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xianming Luo, Doctor · Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-12
Primary Completion
2029-05-31
Completion
2030-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07207070 on ClinicalTrials.gov