Recruiting 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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JS105, Dalpiciclib, Fulvestrant 50 Mg/mL Intramuscular Solution.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug JS105
Patients will receive oral JS105 on Days 1-28 of each 4-week cycle. - Drug Dalpiciclib
Patients will receive oral Dalpiciclib for 3 weeks, followed by 1 week off in each 4-week cycle； - 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.
Primary outcome measures
- Blind Independent Central Review (BICR) assessed PFS based on RECIST v1.1 (BICR-PFS) [Time frame: Up to 3.5 years]
Secondary outcome measures (8)
- Overall Survival (OS) [Time frame: Up to 5 years]
- Investigator-assessed Progression-Free Survival (PFS) [Time frame: Up to 3.5 years]
- 1-year and 2-year Progression-Free Survival (PFS) rate [Time frame: Up to 3.5 years]
- Objective Response Rate (ORR) [Time frame: Up to 5 years]
- Duration of Objective Response (DOR) [Time frame: Up to 5 years]
- Disease Control Rate(DCR) [Time frame: Up to 5 years]
- Adverse Event [Time frame: Up to 5 years]
- Plasma Concentration of JS105 [Time frame: Up to 3.5 years]
Eligibility criteria
Inclusion criteria
- At the time of signing the consent form, age must be between 18 and 75 years old, males and females;
- Patients with unresectable PIK3CA-mutated HR-positive HER2-negative recurrent or metastatic breast cancer;
- Consent to provide tumour tissue or blood samples to determine the PIK3CA mutation status;
- ECOG 0 or 1;
- At least one measurable lesion as per RECIST v1.1, or only bone metastases;
- Expected survival≥12 weeks;
- Good organ function;
- Patients voluntarily join the study and sign the informed consent;
Exclusion criteria
- Previously treated with fulvestrant or PI3K/AKT/mTOR inhibitors;
- Presence of untreated or active central nervous system (CNS) metastases;
- Presence of significant clinical symptoms or uncontrolled pleural effusion, ascites, or pericardial effusion that require repeated drainage (once a month or more frequently);
- 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;
- Have received other anti-tumor treatment within 2-4 weeks before the first dose;
- Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1;
- 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;
- 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;
- Active hepatitis B or C;
- Known hypersensitivity to any of the study drugs or their excipients;
- Pregnant or breastfeeding females;
- 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Chinese Acadamy of Medical Sciences and Peking Union Medical College — Beijing
- Henan Provincial Cancer Hospital — Zhengzhou
Identifiers
NCT: NCT07207070 · JS105-004-III-BC