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.
| NCT ID | NCT07207070 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Risen (Suzhou) Pharma Tech Co., Ltd. |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 312 participants |
| Start Date | 2025-11-12 |
| Primary Completion | 2029-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 312 participants in total. It began in 2025-11-12 with a primary completion date of 2029-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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;
Contact & Investigator
Xianming Luo, Doctor
STUDY DIRECTOR
Medical Director
Frequently Asked Questions
Who can join the NCT07207070 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07207070 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 312 participants.
Is NCT07207070 currently recruiting?
Yes, NCT07207070 is actively recruiting participants. Contact the research team at zhan@junshipharma.com for enrollment information.
Where is the NCT07207070 trial being conducted?
This trial is being conducted at Beijing, China, Zhengzhou, China.
Who is sponsoring the NCT07207070 clinical trial?
NCT07207070 is sponsored by Risen (Suzhou) Pharma Tech Co., Ltd.. The principal investigator is Xianming Luo, Doctor at Medical Director. The trial plans to enroll 312 participants.
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