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Compares treatment options for Breast Cancer
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.
ClinicalTrials.gov ID: NCT07207070
What this study is testing
What is JS105?
JS105 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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;
You likely can't join if
- 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...
- Untreated spinal cord compression, or previously treated spinal cord compression without clinical evidence of disease stability for at least 4 weeks...
- 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;
See the full eligibility 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;
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.