Adding JS105 to dalpiciclib and fulvestrant for PIK3CA‑mutated, HR‑positive, HER2‑negative recurrent or metastatic breast cancer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open‑label, multicentre Phase III comparison of JS105 plus dalpiciclib and fulvestrant versus dalpiciclib and fulvestrant alone in adults with PIK3CA‑mutated, HR‑positive, HER2‑negative recurrent or metastatic breast cancer. Eligible patients are 18–75 years old with ECOG 0–1 and at least one measurable lesion or bone‑only metastases and must provide tumor tissue or blood for PIK3CA testing. Key exclusions include prior fulvestrant or PI3K/AKT/mTOR inhibitor treatment and untreated or active CNS metastases or significant uncontrolled effusions. The trial measures efficacy and safety outcomes to determine whether the three‑drug combination provides better disease control than the two‑drug regimen.

Why it matters

Who can join: the full rules

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;

Where it's running

• Chinese Acadamy of Medical Sciences and Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting
• Henan Provincial Cancer Hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Qianna Zhan, Master
• Email: zhan@junshipharma.com
• Phone: 13526615319

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.