OncoMatch/Clinical Trials/NCT07207070
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.
Is NCT07207070 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including JS105 and Dalpiciclib for breast cancer.
Treatment: JS105 · Dalpiciclib · Fulvestrant 50 Mg/mL Intramuscular Solution — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PIK3CA mutation
PIK3CA-mutated
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: fulvestrant
Previously treated with fulvestrant
Cannot have received: PI3K/AKT/mTOR inhibitor
Previously treated with PI3K/AKT/mTOR inhibitors
Cannot have received: other anti-tumor treatment
Have received other anti-tumor treatment within 2-4 weeks before the first dose
Lab requirements
Blood counts
Good organ function
Kidney function
Good organ function
Liver function
Good organ function
Good organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07207070 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior fulvestrant, PI3K/AKT/mTOR inhibitor, other anti-tumor treatment disqualifies patients from enrollment.
Does this trial require PIK3CA?
Yes, PIK3CA mutation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages