Actively Recruiting
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.
Led by Risen (Suzhou) Pharma Tech Co., Ltd. · Updated on 2025-12-30
312
Participants Needed
2
Research Sites
237 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Unresectable PIK3CA-mutated hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer
- Consent to provide tumor tissue or blood samples to confirm PIK3CA mutation
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable lesion by RECIST v1.1 or bone metastases only
- Expected survival of at least 12 weeks
- Good organ function
- Voluntary participation with signed informed consent
You will not qualify if you...
- Previous treatment with fulvestrant or PI3K/AKT/mTOR inhibitors
- Untreated or active central nervous system metastases
- Significant symptoms or uncontrolled fluid buildup requiring frequent drainage
- Untreated spinal cord compression or unstable previously treated spinal cord compression
- Anti-tumor treatment within 2 to 4 weeks before starting study treatment
- Unresolved toxicities from prior anti-tumor therapy above Grade 1
- Uncontrolled diseases including type I diabetes or uncontrolled type II diabetes, active infection, severe cardiovascular or cerebrovascular disease
- Another malignant tumor within 5 years except those expected to be cured
- Active hepatitis B or C infection
- Known allergy to study drugs or their ingredients
- Pregnant or breastfeeding women
- Other serious physical or mental conditions or lab abnormalities that increase study risk or affect compliance, as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Chinese Acadamy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Henan Provincial Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
Research Team
Q
Qianna Zhan, Master
CONTACT
H
Huiyu Lan, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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