Breast CancerPhase 3NCT07207070
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.
A Phase 3 study testing JS105, Dalpiciclib and Fulvestrant 50 Mg/mL Intramuscular Solution in people with Breast Cancer, run by Risen (Suzhou) Pharma Tech Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- JS105, Dalpiciclib and Fulvestrant 50 Mg/mL Intramuscular Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 2 sitesChina
- Study dates
- 12 Nov 2025to 31 May 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Chinese Acadamy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Min Yan, Ph.D, 0371-65588404, ym200678@126.com
Min Yan, Ph.D
- Recruiting
Henan Provincial Cancer Hospital
Zhengzhou, Henan, 450003
Binghe Xu, Ph.D, 13501028690, xubinghe@medmail.com.cn
Binghe Xu, Ph.D
About this study
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
- Breast Cancer
- Being tested
- JS105, Dalpiciclib, Fulvestrant 50 Mg/mL Intramuscular Solution
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS105Drug
Patients will receive oral JS105 on Days 1-28 of each 4-week cycle.
DalpiciclibDrug
Patients will receive oral Dalpiciclib for 3 weeks, followed by 1 week off in each 4-week cycle；
Fulvestrant 50 Mg/mL Intramuscular SolutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| JS105+Dalpiciclib+Fulvestrant | Experimental | Patients will receive JS105, Dalpiciclib and Fulvestrant. Receives: Drug: JS105; Drug: Dalpiciclib; Drug: Fulvestrant 50 Mg/mL Intramuscular Solution |
| Dalpiciclib+Fulvestrant | Active comparator | Patients will receive Dalpiciclib and Fulvestrant. Receives: Drug: Dalpiciclib; Drug: Fulvestrant 50 Mg/mL Intramuscular Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blind Independent Central Review (BICR) assessed PFS based on RECIST v1.1 (BICR-PFS)
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first).
Measured: Up to 3.5 years
Secondary outcomes (8)
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Measured: Up to 5 years
Investigator-assessed Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first).
Measured: Up to 3.5 years
1-year and 2-year Progression-Free Survival (PFS) rate
1-year and 2-year Progression-Free Survival (PFS) rate
Measured: Up to 3.5 years
Objective Response Rate (ORR)
Objective Response Rate (ORR) as Assessed by Investigator or BICR according to RECIST v1.1
Measured: Up to 5 years
Duration of Objective Response (DOR)
Duration of Objective Response (DOR) as Assessed by Investigator or BICR according to RECIST v1.1
Measured: Up to 5 years
Disease Control Rate(DCR)
Disease Control Rate(DCR) as Assessed by Investigator or BICR according to RECIST v1.1
Measured: Up to 5 years
Adverse Event
Collect Serious Adverse Events (SAEs) and Adverse Events (AEs) from the time of signing the Informed Consent Form (ICF) until the safety follow-up visit.Evaluate the safety of the investigational drug.
Measured: Up to 5 years
Plasma Concentration of JS105
Collect JS105 PK sample to evaluate the blood drug concentration after the administration of JS105.
Measured: Up to 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start12 Nov 2025
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group：JS105:Dose according to the protocal, orally, once daily (QD), administered continuously. Dalpiciclib :Dose according to the protocal, orally, QD, taken for 3 weeks, followedby 1 week off in each 4-week cycle； Fulvestrant Dose according to the protocal, administered intramuscularly on day 1 and day 15 of the first cycle and then on day 1 of each subsequent 4-week cycle. Control group：Dalpiciclib : Dose according to the protocal, orally, QD, taken for 3 weeks, followed by 1 week off in each 4-week cycle；Fulvestrant: Dose according to the protocal, administered intramuscularly on day 1 and day 15 of the first cycle and then on day 1 of each subsequent 4-week cycle.
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Risen (Suzhou) Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xianming Luo, Doctor, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207070
- Sponsor's protocol ID
- JS105-004-III-BC
- Status last verified
- Dec 2025
- First submitted
- 26 Sep 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- JS105-004-III-BC
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Risen (Suzhou) Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group：JS105:Dose according to the protocal, orally, once daily (QD), administered continuously. Dalpiciclib :Dose according to the protocal, orally, QD, taken for 3 weeks, followedby 1 week off in each 4-week cycle； Fulvestrant Dose according to the protocal, administered intramuscularly on day 1 and day 15 of the first cycle and then on day 1 of each subsequent 4-week cycle. Control group：Dalpiciclib : Dose according to the protocal, orally, QD, taken for 3 weeks, followed by 1 week off in each 4-week cycle；Fulvestrant: Dose according to the protocal, administered intramuscularly on day 1 and day 15 of the first cycle and then on day 1 of each subsequent 4-week cycle.
| Arm | Type | Receives |
|---|---|---|
| JS105+Dalpiciclib+Fulvestrant | Experimental | Drug: JS105, Drug: Dalpiciclib, Drug: Fulvestrant 50 Mg/mL Intramuscular SolutionPatients will receive JS105, Dalpiciclib and Fulvestrant. |
| Dalpiciclib+Fulvestrant | Active comparator | Drug: Dalpiciclib, Drug: Fulvestrant 50 Mg/mL Intramuscular SolutionPatients will receive Dalpiciclib and Fulvestrant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS105Patients will receive oral JS105 on Days 1-28 of each 4-week cycle. | Drug | JS105+Dalpiciclib+Fulvestrant |
| DalpiciclibPatients will receive oral Dalpiciclib for 3 weeks, followed by 1 week off in each 4-week cycle； | Drug | Dalpiciclib+Fulvestrant, JS105+Dalpiciclib+Fulvestrant |
| Fulvestrant 50 Mg/mL Intramuscular SolutionPatients 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. | Drug | Dalpiciclib+Fulvestrant, JS105+Dalpiciclib+Fulvestrant |
Primary outcome
Blind Independent Central Review (BICR) assessed PFS based on RECIST v1.1 (BICR-PFS)
Time frame: Up to 3.5 years
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first).
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xianming Luo, Doctor study director
Medical Director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JS105, Dalpiciclib and Fulvestrant 50 Mg/mL Intramuscular Solution in people with Breast Cancer, run by Risen (Suzhou) Pharma Tech Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qianna Zhan, Master (13526615319, zhan@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blind Independent Central Review (BICR) assessed PFS based on RECIST v1.1 (BICR-PFS) (time frame: Up to 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.