Locally Advanced or Metastatic Breast CancerPhase 3NCT07354022
A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.
A Phase 3 study testing HRS-8080 Tablet ; Dalpiciclib Isethionate and Fulvestrant injection ;Dalpiciclib Isethionate in people with Locally Advanced or Metastatic Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Locally Advanced or Metastatic Breast Cancer
- What is being tested?
- HRS-8080 Tablet ; Dalpiciclib Isethionate and Fulvestrant injection ;Dalpiciclib Isethionate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 912 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2026to Dec 2031
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 - 75 years old;
- Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1;
- Patients with histologically confirmed locally advanced or metastatic breast cancer;
- Patients with prior adjuvant endocrine resistance following curative-intent surgery;
- Menstrual status: postmenopausal, perimenopausal, or premenopausal;
- Presence of evaluable lesions;
- Organ function must meet required criteria.
Who cannot join
- Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy;
- Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene);
- Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression;
- Patients with a history of clinically significant cardiovascular disease;
- Participants who have not recovered from adverse effects caused by prior therapies;
- Participants with a history of another malignancy within the past 5 years or currently having another malignancy;
- Known hypersensitivity to HRS-8080, fulvestrant, dalpiciclib, or any of their components, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital Fifth Medical Center
Beijing, Beijing Municipality, 100000
Zefei Jiang
About this study
Official title: A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.
The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.
- Being tested
- HRS-8080 Tablet ; Dalpiciclib Isethionate, Fulvestrant injection ;Dalpiciclib Isethionate
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-8080 Tablet ; Dalpiciclib IsethionateDrug
- HRS-8080 Tablet
- Dalpiciclib Isethionate
Fulvestrant injection ;Dalpiciclib IsethionateDrug
- Fulvestrant injection
- Dalpiciclib Isethionate
| Study group | Role | What they receive |
|---|---|---|
| HRS-8080 combined with Dalpiciclib | Experimental | Not described Receives: Drug: HRS-8080 Tablet ; Dalpiciclib Isethionate |
| Fulvestrant combined with Dalpiciclib | Active comparator | Not described Receives: Drug: Fulvestrant injection ;Dalpiciclib Isethionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator assessed Progression free survival (PFS)
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause during the study.
Measured: Up to 5 years.
Secondary outcomes (12)
Progression free survival (PFS) evaluated by the blinded independent central review (BICR)
Measured: Up to 5 years
Overall response rate (ORR)
Measured: Up to 5 years
Clinical benefit rate (CBR)
Measured: Up to 5 years
Duration of response (DOR)
Measured: Up to 5 years
Overall survival (OS)
Measured: Up to 8 years
The incidence and severity of adverse events (AEs)
Measured: Up to 5 years
The incidence and severity of serious adverse events (SAEs)
Measured: Up to 5 years
Number of participants with vital sign abnormalities over the course of the study. Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature
Measured: Up to 5 years
Number of participants with clinical laboratory test abnormalities for haematology and biochemistry parameters over the course of the study
Measured: Up to 5 years
Heart rate (beats per minute) measured by 12-lead electrocardiography.
Measured: Up to 5 years
QT interval (ms) measured by 12-lead electrocardiography.
Eastern Cooperative Oncology Group (ECOG) performance status. ECOG performance status was measured on a 6 point grade scale.
0: Fully active, able to carry on all pre-disease performance without restriction.
- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- Dead.
Measured: Up to 5 years
Plasma concentrations of HRS-8080 and dalpiciclib isethionate
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start5 May 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 912 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354022
- Sponsor's protocol ID
- HRS-8080-301
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.
- ClinicalTrials.gov ID
- NCT07354022
- Acronym / sponsor ID
- HRS-8080-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 912 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 May 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 21 Jan 2026 (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.
The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-8080 combined with Dalpiciclib | Experimental | Drug: HRS-8080 Tablet ; Dalpiciclib Isethionate |
| Fulvestrant combined with Dalpiciclib | Active comparator | Drug: Fulvestrant injection ;Dalpiciclib Isethionate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged 18 - 75 years old;
- Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1;
- Patients with histologically confirmed locally advanced or metastatic breast cancer;
- Patients with prior adjuvant endocrine resistance following curative-intent surgery;
- Menstrual status: postmenopausal, perimenopausal, or premenopausal;
Key exclusion criteria (7 listed)
- Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy;
- Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene);
- Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression;
- Patients with a history of clinically significant cardiovascular disease;
- Participants who have not recovered from adverse effects caused by prior therapies;
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 |
|---|---|---|
| HRS-8080 Tablet ; Dalpiciclib Isethionate* HRS-8080 Tablet * Dalpiciclib Isethionate | Drug | HRS-8080 combined with Dalpiciclib |
| Fulvestrant injection ;Dalpiciclib Isethionate* Fulvestrant injection * Dalpiciclib Isethionate | Drug | Fulvestrant combined with Dalpiciclib |
Primary outcome
Investigator assessed Progression free survival (PFS)
Time frame: Up to 5 years.
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause during the study.
12 secondary outcomes
Progression free survival (PFS) evaluated by the blinded independent central review (BICR)
Time frame: Up to 5 years
Overall response rate (ORR)
Time frame: Up to 5 years
Clinical benefit rate (CBR)
Time frame: Up to 5 years
Duration of response (DOR)
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 8 years
The incidence and severity of adverse events (AEs)
Time frame: Up to 5 years
The incidence and severity of serious adverse events (SAEs)
Time frame: Up to 5 years
Number of participants with vital sign abnormalities over the course of the study. Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature
Time frame: Up to 5 years
Number of participants with clinical laboratory test abnormalities for haematology and biochemistry parameters over the course of the study
Time frame: Up to 5 years
Heart rate (beats per minute) measured by 12-lead electrocardiography.
Time frame: Up to 5 years
QT interval (ms) measured by 12-lead electrocardiography.
Time frame: Up to 5 years
Plasma concentrations of HRS-8080 and dalpiciclib isethionate
Time frame: Up to approximately 2 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 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HRS-8080 Tablet ; Dalpiciclib Isethionate and Fulvestrant injection ;Dalpiciclib Isethionate in people with Locally Advanced or Metastatic Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 1 site 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 7 inclusion and 7 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Zhan Zhang (+86 17721286165, Zhan.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator assessed Progression free survival (PFS) (time frame: Up to 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 2 Jun 2026.