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.

NCT ID: NCT07207070

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-12
• Study Completion Date: 2030-05-31

Brief 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

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JS105+Dalpiciclib+Fulvestrant

Patients will receive JS105, Dalpiciclib and Fulvestrant.

Group Type: EXPERIMENTAL

JS105

Intervention Type: DRUG

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

Dalpiciclib

Intervention Type: DRUG

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

Fulvestrant 50 Mg/mL Intramuscular Solution

Intervention Type: DRUG

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.

Dalpiciclib+Fulvestrant

Patients will receive Dalpiciclib and Fulvestrant.

Group Type: ACTIVE_COMPARATOR

Dalpiciclib

Intervention Type: DRUG

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

Fulvestrant 50 Mg/mL Intramuscular Solution

Intervention Type: DRUG

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.

Interventions

JS105

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

Intervention Type: DRUG

Dalpiciclib

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. At the time of signing the consent form, age must be between 18 and 75 years old, males and females;

2. Patients with unresectable PIK3CA-mutated HR-positive HER2-negative recurrent or metastatic breast cancer;

3. Consent to provide tumour tissue or blood samples to determine the PIK3CA mutation status;

4. ECOG 0 or 1;

5. At least one measurable lesion as per RECIST v1.1, or only bone metastases;

6. Expected survival≥12 weeks;

7. Good organ function;

8. Patients voluntarily join the study and sign the informed consent;

Exclusion Criteria

1. Previously treated with fulvestrant or PI3K/AKT/mTOR inhibitors;

2. Presence of untreated or active central nervous system (CNS) metastases;

3. Presence of significant clinical symptoms or uncontrolled pleural effusion, ascites, or pericardial effusion that require repeated drainage (once a month or more frequently);

4. Untreated spinal cord compression, or previously treated spinal cord compression without clinical evidence of disease stability for at least 4 weeks prior to the first study treatment;

5. Have received other anti-tumor treatment within 2-4 weeks before the first dose;

6. Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1;

7. Coexisting uncontrolled accompanying diseases, including but not limited to: history of type I diabetes or uncontrolled type II diabetes, presence of active infection, severe cardiovascular or cerebrovascular diseases, etc;

8. Having another malignant tumour within the last 5 years prior to the first study treatment, except for malignancies that are expected to be cured after treatment;

9. Active hepatitis B or C;

10. Known hypersensitivity to any of the study drugs or their excipients;

11. Pregnant or breastfeeding females;

12. Presence of other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participation in the study, affect treatment compliance, or interfere with study results, as judged by the investigator;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Risen (Suzhou) Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xianming Luo, Doctor

Role: STUDY_DIRECTOR

Medical Director

Locations

Chinese Acadamy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Henan Provincial Cancer Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qianna Zhan, Master

Role: CONTACT

Phone: 13526615319

Email: zhan@junshipharma.com

Huiyu Lan, Master

Role: CONTACT

Phone: 15000239047

Email: huiyu_lan@junshipharma.com

Facility Contacts

Min Yan, Ph.D

Role: primary

Binghe Xu, Ph.D

Role: primary

Other Identifiers

JS105-004-III-BC

Identifier Type: -

Identifier Source: org_study_id